← Trials/Trial dossier/NCT03018028
PIONEER 9
CompletedPhase 3Results postedDose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes
Lead sponsor
Assets
Liraglutide / Semaglutide
Listed sites
16
Recruiting sites
—
Enrollment
243
actual
Study population
Type 2 diabetes
Key I/E criterion
•HbA1c 6.5-9.5%
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
Exclusion criteria
Endpoints (100)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
12 endpointsChange in Body Weight (kg)
Time frame:Week 0, week 26, week 52
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (mean), Kilogram (kg) | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | -0.4 | — |
| Week 52 | 0.0 | — |
| Oral Semaglutide 7 mgWeek 26 | -1.2 | — |
| Week 52 | -0.8 | — |
| Oral Semaglutide 14 mgWeek 26 | -2.4 | — |
| Week 52 | -2.9 | — |
| Liraglutide 0.9 mgWeek 26 | 0.1 | — |
| Week 52 | 0.5 | — |
| PlaceboWeek 26 | -1.1 | — |
| Week 52 | -1.0 | — |
Change in Body Weight (%)
Time frame:Week 0, week 26 and week 52
Body weight, % change
percent change from baseline, improvement
Posted result
| Group | Value (mean), Percentage change | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | -0.64 | — |
| Week 52 | -0.03 | — |
| Oral Semaglutide 7 mgWeek 26 | -1.63 | — |
| Week 52 | -1.23 | — |
| Oral Semaglutide 14 mgWeek 26 | -3.54 | — |
| Week 52 | -4.42 | — |
| Liraglutide 0.9 mgWeek 26 | 0.08 | — |
| Week 52 | 0.68 | — |
| PlaceboWeek 26 | -1.58 | — |
| Week 52 | -1.42 | — |
Change in Body Mass Index
Time frame:Week 0, week 26 and week 52
BMI, change
change from baseline, improvement
Posted result
| Group | Value (mean), Kilogram per square meter (kg/m^2) | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | -0.1 | — |
| Week 52 | 0.0 | — |
| Oral Semaglutide 7 mgWeek 26 | -0.4 | — |
| Week 52 | -0.3 | — |
| Oral Semaglutide 14 mgWeek 26 | -0.9 | — |
| Week 52 | -1.1 | — |
| Liraglutide 0.9 mgWeek 26 | 0.0 | — |
| Week 52 | 0.2 | — |
| PlaceboWeek 26 | -0.4 | — |
| Week 52 | -0.4 | — |
Change in Waist Circumference
Time frame:Week 0, week 26 and week 52
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (mean), Centimeters (cm) | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 0.5 | — |
| Week 52 | 0.2 | — |
| Oral Semaglutide 7 mgWeek 26 | -0.6 | — |
| Week 52 | -1.0 | — |
| Oral Semaglutide 14 mgWeek 26 | -1.3 | — |
| Week 52 | -2.7 | — |
| Liraglutide 0.9 mgWeek 26 | 0.0 | — |
| Week 52 | 1.0 | — |
| PlaceboWeek 26 | -0.5 | — |
| Week 52 | -0.9 | — |
Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No)
Time frame:Week 26 and week 52
≥5% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 1 | — |
| Week 26 | 42 | — |
| Week 52 | 1 | — |
| Week 52 | 37 | — |
| Oral Semaglutide 7 mgWeek 26 | 5 | — |
| Week 26 | 40 | — |
| Week 52 | 5 | — |
| Week 52 | 38 | — |
| Oral Semaglutide 14 mgWeek 26 | 16 | — |
| Week 26 | 28 | — |
| Week 52 | 17 | — |
| Week 52 | 24 | — |
| Liraglutide 0.9 mgWeek 26 | 0 | — |
| Week 26 | 45 | — |
| Week 52 | 2 | — |
| Week 52 | 39 | — |
| PlaceboWeek 26 | 3 | — |
| Week 26 | 38 | — |
| Week 52 | 2 | — |
| Week 52 | 32 | — |
Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No)
Time frame:Week 26 and week 52
≥10% weight-loss responders
threshold achievement, improvement
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 0 | — |
| Week 26 | 43 | — |
| Week 52 | 0 | — |
| Week 52 | 38 | — |
| Oral Semaglutide 7 mgWeek 26 | 0 | — |
| Week 26 | 45 | — |
| Week 52 | 1 | — |
| Week 52 | 42 | — |
| Oral Semaglutide 14 mgWeek 26 | 3 | — |
| Week 26 | 41 | — |
| Week 52 | 6 | — |
| Week 52 | 35 | — |
| Liraglutide 0.9 mgWeek 26 | 0 | — |
| Week 26 | 45 | — |
| Week 52 | 0 | — |
| Week 52 | 41 | — |
| PlaceboWeek 26 | 0 | — |
| Week 26 | 41 | — |
| Week 52 | 0 | — |
| Week 52 | 34 | — |
Change in Body Weight (kg)
Time frame:Week 0, week 26, week 52
Body weight, absolute change (kg)
change from baseline, improvement
Change in Body Weight (%)
Time frame:Week 0, week 26 and week 52
Body weight, % change
percent change from baseline, improvement
Change in Body Mass Index
Time frame:Week 0, week 26 and week 52
BMI, change
change from baseline, improvement
Change in Waist Circumference
Time frame:Week 0, week 26 and week 52
Waist circumference, change
change from baseline, improvement
Participants Who Achieved Weight Loss Above or Equal to 5% (Yes/No)
Time frame:Week 26 and week 52
≥5% weight-loss responders
threshold achievement, improvement
Participants Who Achieved Weight Loss Above or Equal to 10% (Yes/No)
Time frame:Week 26 and week 52
≥10% weight-loss responders
threshold achievement, improvement
Glycemic / diabetes
35 endpointsChange in HbA1c (Week 26)
Time frame:Week 0, week 26
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Percentage point of HbA1c | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgOn-treatment without rescue medication | -1.1 | — |
| In-trial observation period | -1.1 | — |
| Oral Semaglutide 7 mgOn-treatment without rescue medication | -1.7 | — |
| In-trial observation period | -1.6 | — |
| Oral Semaglutide 14 mgOn-treatment without rescue medication | -1.7 | — |
| In-trial observation period | -1.7 | — |
| Liraglutide 0.9 mgOn-treatment without rescue medication | -1.4 | — |
| In-trial observation period | -1.4 | — |
| PlaceboOn-treatment without rescue medication | -0.2 | — |
| In-trial observation period | -0.4 | — |
Change in HbA1c (Week 26)
Time frame:Week 0, week 26
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in HbA1c (Week 52)
Time frame:Week 0, week 52
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Posted result
| Group | Value (mean), Percentage of HbA1c | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mg | -1.0 | — |
| Oral Semaglutide 7 mg | -1.4 | — |
| Oral Semaglutide 14 mg | -1.5 | — |
| Liraglutide 0.9 mg | -1.3 | — |
| Placebo | 0.1 | — |
Change in Fasting Plasma Glucose
Time frame:Week 0, week 26, week 52
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Posted result
| Group | Value (mean), Millimoles per liter (mmol/L) | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | -1.62 | — |
| Week 52 | -1.13 | — |
| Oral Semaglutide 7 mgWeek 26 | -1.60 | — |
| Week 52 | -1.60 | — |
| Oral Semaglutide 14 mgWeek 26 | -2.37 | — |
| Week 52 | -2.29 | — |
| Liraglutide 0.9 mgWeek 26 | -2.48 | — |
| Week 52 | -2.28 | — |
| PlaceboWeek 26 | -0.37 | — |
| Week 52 | 0.33 | — |
Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile
Time frame:Week 0, week 26, week 52
Postprandial glucose
change from baseline, improvement
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | -2.2 | — |
| Week 52 | -1.7 | — |
| Oral Semaglutide 7 mgWeek 26 | -2.6 | — |
| Week 52 | -2.2 | — |
| Oral Semaglutide 14 mgWeek 26 | -3.1 | — |
| Week 52 | -3.1 | — |
| Liraglutide 0.9 mgWeek 26 | -2.8 | — |
| Week 52 | -2.3 | — |
| PlaceboWeek 26 | -0.8 | — |
| Week 52 | -0.0 | — |
Change in Mean Postprandial Increment Over All Meals in SMPG
Time frame:Week 0, week 26 and week 52
Postprandial glucose
change from baseline, improvement
Posted result
| Group | Value (mean), mmol/L | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | -0.7 | — |
| Week 52 | -0.5 | — |
| Oral Semaglutide 7 mgWeek 26 | -1.2 | — |
| Week 52 | -0.9 | — |
| Oral Semaglutide 14 mgWeek 26 | -2.0 | — |
| Week 52 | -2.0 | — |
| Liraglutide 0.9 mgWeek 26 | -1.1 | — |
| Week 52 | -0.6 | — |
| PlaceboWeek 26 | -0.5 | — |
| Week 52 | -0.1 | — |
Change in Fasting Insulin (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of insulin | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 1.19 | — |
| Week 52 | 1.07 | — |
| Oral Semaglutide 7 mgWeek 26 | 1.27 | — |
| Week 52 | 1.16 | — |
| Oral Semaglutide 14 mgWeek 26 | 1.10 | — |
| Week 52 | 1.04 | — |
| Liraglutide 0.9 mgWeek 26 | 1.14 | — |
| Week 52 | 1.06 | — |
| PlaceboWeek 26 | 0.92 | — |
| Week 52 | 0.93 | — |
Change in Fasting C-peptide (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of C-peptide | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 1.15 | — |
| Week 52 | 1.12 | — |
| Oral Semaglutide 7 mgWeek 26 | 1.24 | — |
| Week 52 | 1.19 | — |
| Oral Semaglutide 14 mgWeek 26 | 1.17 | — |
| Week 52 | 1.10 | — |
| Liraglutide 0.9 mgWeek 26 | 1.18 | — |
| Week 52 | 1.11 | — |
| PlaceboWeek 26 | 0.98 | — |
| Week 52 | 0.99 | — |
Change in Fasting Pro-insulin (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of pro-insulin | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 0.69 | — |
| Week 52 | 0.83 | — |
| Oral Semaglutide 7 mgWeek 26 | 0.68 | — |
| Week 52 | 0.78 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.51 | — |
| Week 52 | 0.56 | — |
| Liraglutide 0.9 mgWeek 26 | 0.61 | — |
| Week 52 | 0.72 | — |
| PlaceboWeek 26 | 0.85 | — |
| Week 52 | 1.04 | — |
Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of pro-insulin/insulin ratio | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 0.59 | — |
| Week 52 | 0.78 | — |
| Oral Semaglutide 7 mgWeek 26 | 0.54 | — |
| Week 52 | 0.67 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.49 | — |
| Week 52 | 0.56 | — |
| Liraglutide 0.9 mgWeek 26 | 0.55 | — |
| Week 52 | 0.69 | — |
| PlaceboWeek 26 | 0.92 | — |
| Week 52 | 1.11 | — |
Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
HOMA-IR (insulin sensitivity)
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of insulin resistance | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 0.98 | — |
| Week 52 | 0.93 | — |
| Oral Semaglutide 7 mgWeek 26 | 1.02 | — |
| Week 52 | 0.95 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.83 | — |
| Week 52 | 0.78 | — |
| Liraglutide 0.9 mgWeek 26 | 0.86 | — |
| Week 52 | 0.82 | — |
| PlaceboWeek 26 | 0.88 | — |
| Week 52 | 0.97 | — |
Change in Beta-cell Function (HOMA-B) (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of beta-cell function | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 1.71 | — |
| Week 52 | 1.36 | — |
| Oral Semaglutide 7 mgWeek 26 | 1.93 | — |
| Week 52 | 1.75 | — |
| Oral Semaglutide 14 mgWeek 26 | 1.95 | — |
| Week 52 | 1.86 | — |
| Liraglutide 0.9 mgWeek 26 | 1.89 | — |
| Week 52 | 1.69 | — |
| PlaceboWeek 26 | 1.00 | — |
| Week 52 | 0.89 | — |
Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no)
Time frame:Week 26 and week 52
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 24 | — |
| Week 26 | 19 | — |
| Week 52 | 19 | — |
| Week 52 | 19 | — |
| Oral Semaglutide 7 mgWeek 26 | 33 | — |
| Week 26 | 12 | — |
| Week 52 | 29 | — |
| Week 52 | 14 | — |
| Oral Semaglutide 14 mgWeek 26 | 35 | — |
| Week 26 | 9 | — |
| Week 52 | 33 | — |
| Week 52 | 8 | — |
| Liraglutide 0.9 mgWeek 26 | 24 | — |
| Week 26 | 21 | — |
| Week 52 | 20 | — |
| Week 52 | 21 | — |
| PlaceboWeek 26 | 6 | — |
| Week 26 | 35 | — |
| Week 52 | 4 | — |
| Week 52 | 30 | — |
Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No)
Time frame:Week 26 and week 52
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 13 | — |
| Week 26 | 30 | — |
| Week 52 | 11 | — |
| Week 52 | 27 | — |
| Oral Semaglutide 7 mgWeek 26 | 24 | — |
| Week 26 | 21 | — |
| Week 52 | 20 | — |
| Week 52 | 23 | — |
| Oral Semaglutide 14 mgWeek 26 | 28 | — |
| Week 26 | 16 | — |
| Week 52 | 24 | — |
| Week 52 | 17 | — |
| Liraglutide 0.9 mgWeek 26 | 16 | — |
| Week 26 | 29 | — |
| Week 52 | 11 | — |
| Week 52 | 30 | — |
| PlaceboWeek 26 | 2 | — |
| Week 26 | 39 | — |
| Week 52 | 1 | — |
| Week 52 | 33 | — |
Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)
Time frame:Week 26 and week 52
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 15 | — |
| Week 26 | 28 | — |
| Week 52 | 12 | — |
| Week 52 | 26 | — |
| Oral Semaglutide 7 mgWeek 26 | 26 | — |
| Week 26 | 19 | — |
| Week 52 | 24 | — |
| Week 52 | 19 | — |
| Oral Semaglutide 14 mgWeek 26 | 30 | — |
| Week 26 | 14 | — |
| Week 52 | 28 | — |
| Week 52 | 13 | — |
| Liraglutide 0.9 mgWeek 26 | 15 | — |
| Week 26 | 30 | — |
| Week 52 | 9 | — |
| Week 52 | 32 | — |
| PlaceboWeek 26 | 4 | — |
| Week 26 | 37 | — |
| Week 52 | 4 | — |
| Week 52 | 30 | — |
Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3%
Time frame:Week 26 and week 52
threshold achievement, improvement
componentsHbA1c, change, Body weight, % change
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 7 | — |
| Week 26 | 36 | — |
| Week 52 | 8 | — |
| Week 52 | 30 | — |
| Oral Semaglutide 7 mgWeek 26 | 11 | — |
| Week 26 | 34 | — |
| Week 52 | 7 | — |
| Week 52 | 36 | — |
| Oral Semaglutide 14 mgWeek 26 | 21 | — |
| Week 26 | 23 | — |
| Week 52 | 20 | — |
| Week 52 | 21 | — |
| Liraglutide 0.9 mgWeek 26 | 5 | — |
| Week 26 | 40 | — |
| Week 52 | 2 | — |
| Week 52 | 39 | — |
| PlaceboWeek 26 | 3 | — |
| Week 26 | 38 | — |
| Week 52 | 1 | — |
| Week 52 | 33 | — |
Time to Additional Anti-diabetic Medication
Time frame:Weeks 0 - 52
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgUp to Week 26 | 3 | — |
| Up to Week 52 | 8 | — |
| Oral Semaglutide 7 mgUp to Week 26 | 3 | — |
| Up to Week 52 | 6 | — |
| Oral Semaglutide 14 mgUp to Week 26 | 1 | — |
| Up to Week 52 | 4 | — |
| Liraglutide 0.9 mgUp to Week 26 | 0 | — |
| Up to Week 52 | 4 | — |
| PlaceboUp to Week 26 | 7 | — |
| Up to Week 52 | 15 | — |
Time to Rescue Medication
Time frame:Weeks 0 - 52
time to event, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgUp to Week 26 | 2 | — |
| Up to Week 52 | 7 | — |
| Oral Semaglutide 7 mgUp to Week 26 | 2 | — |
| Up to Week 52 | 5 | — |
| Oral Semaglutide 14 mgUp to Week 26 | 1 | — |
| Up to Week 52 | 4 | — |
| Liraglutide 0.9 mgUp to Week 26 | 0 | — |
| Up to Week 52 | 3 | — |
| PlaceboUp to Week 26 | 7 | — |
| Up to Week 52 | 15 | — |
Change in HbA1c (Week 52)
Time frame:Week 0, week 52
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in Fasting Plasma Glucose
Time frame:Week 0, week 26, week 52
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Change in Self-measured Plasma Glucose 7-point Profile (SMPG) - Mean 7-point Profile
Time frame:Week 0, week 26, week 52
Postprandial glucose
change from baseline, improvement
Change in Mean Postprandial Increment Over All Meals in SMPG
Time frame:Week 0, week 26 and week 52
Postprandial glucose
change from baseline, improvement
Change in Fasting Insulin (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
ratio, improvement
Change in Fasting C-peptide (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
ratio, improvement
Change in Fasting Glucagon (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
ratio, improvement
Change in Fasting Pro-insulin (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
ratio, improvement
Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
ratio, improvement
Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
HOMA-IR (insulin sensitivity)
ratio, improvement
Change in Beta-cell Function (HOMA-B) (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
ratio, improvement
Participants Who Achieved HbA1c < 7.0% (53 mmol/Mol) ADA Target (Yes/no)
Time frame:Week 26 and week 52
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Participants Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol), AACE Target (Yes/No)
Time frame:Week 26 and week 52
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Participants Who Achieved HbA1c Below 7.0% (53 mmol/Mol) Without Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes and no Weight Gain (Yes/No)
Time frame:Week 26 and week 52
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Participants Who Achieved HbA1c Reduction Above or Equal to 1% (10.9 mmol/Mol) and Weight Loss Above or Equal to 3%
Time frame:Week 26 and week 52
threshold achievement, improvement
componentsHbA1c, change, Body weight, % change
Time to Additional Anti-diabetic Medication
Time frame:Weeks 0 - 52
time to event, event
Time to Rescue Medication
Time frame:Weeks 0 - 52
time to event, event
Cardiometabolic biomarkers
15 endpointsChange in Total Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Posted result
| Group | Value (geometric_mean), Ratio of total cholesterol | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 0.92 | — |
| Week 52 | 0.99 | — |
| Oral Semaglutide 7 mgWeek 26 | 0.93 | — |
| Week 52 | 0.95 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.89 | — |
| Week 52 | 0.93 | — |
| Liraglutide 0.9 mgWeek 26 | 0.94 | — |
| Week 52 | 0.95 | — |
| PlaceboWeek 26 | 1.00 | — |
| Week 52 | 1.01 | — |
Change in HDL Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
HDL-C, change
ratio, improvement
LOINC 2085-9
Posted result
| Group | Value (geometric_mean), Ratio of HDL cholesterol | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 0.97 | — |
| Week 52 | 1.05 | — |
| Oral Semaglutide 7 mgWeek 26 | 0.98 | — |
| Week 52 | 1.01 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.96 | — |
| Week 52 | 0.99 | — |
| Liraglutide 0.9 mgWeek 26 | 0.99 | — |
| Week 52 | 0.98 | — |
| PlaceboWeek 26 | 1.03 | — |
| Week 52 | 1.04 | — |
Change in LDL Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
LDL-C, change
ratio, improvement
LOINC 13457-7
Posted result
| Group | Value (geometric_mean), Ratio of LDL cholesterol | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 0.87 | — |
| Week 52 | 0.99 | — |
| Oral Semaglutide 7 mgWeek 26 | 0.89 | — |
| Week 52 | 0.96 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.85 | — |
| Week 52 | 0.91 | — |
| Liraglutide 0.9 mgWeek 26 | 0.91 | — |
| Week 52 | 0.95 | — |
| PlaceboWeek 26 | 1.03 | — |
| Week 52 | 1.06 | — |
Change in VLDL Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
VLDL, change
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of VLDL cholesterol | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 1.02 | — |
| Week 52 | 0.86 | — |
| Oral Semaglutide 7 mgWeek 26 | 0.94 | — |
| Week 52 | 0.84 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.93 | — |
| Week 52 | 0.86 | — |
| Liraglutide 0.9 mgWeek 26 | 0.99 | — |
| Week 52 | 0.87 | — |
| PlaceboWeek 26 | 0.87 | — |
| Week 52 | 0.81 | — |
Change in Triglycerides (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
Triglycerides, change
ratio, improvement
LOINC 2571-8
Posted result
| Group | Value (geometric_mean), Ratio of triglycerides | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 1.03 | — |
| Week 52 | 0.86 | — |
| Oral Semaglutide 7 mgWeek 26 | 0.94 | — |
| Week 52 | 0.84 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.93 | — |
| Week 52 | 0.86 | — |
| Liraglutide 0.9 mgWeek 26 | 0.99 | — |
| Week 52 | 0.87 | — |
| PlaceboWeek 26 | 0.87 | — |
| Week 52 | 0.82 | — |
Change in Fasting Glucagon (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
fasting glucagon ratio to baseline
ratio, improvement
Posted result
| Group | Value (geometric_mean), Ratio of glucagon | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 0.95 | — |
| Week 52 | 0.97 | — |
| Oral Semaglutide 7 mgWeek 26 | 0.89 | — |
| Week 52 | 0.95 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.85 | — |
| Week 52 | 0.92 | — |
| Liraglutide 0.9 mgWeek 26 | 0.91 | — |
| Week 52 | 0.93 | — |
| PlaceboWeek 26 | 0.95 | — |
| Week 52 | 0.96 | — |
Change in Pulse Rate
Time frame:Week 0, week 26, week 52
Heart rate, change
change from baseline, improvement
Posted result
| Group | Value (mean), Beats per minute (beats/min) | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 1 | — |
| Week 52 | 1 | — |
| Oral Semaglutide 7 mgWeek 26 | 2 | — |
| Week 52 | 3 | — |
| Oral Semaglutide 14 mgWeek 26 | 2 | — |
| Week 52 | 4 | — |
| Liraglutide 0.9 mgWeek 26 | 2 | — |
| Week 52 | 2 | — |
| PlaceboWeek 26 | 0 | — |
| Week 52 | 0 | — |
Change in Blood Pressure
Time frame:Week 0, week 26, week 52
change from baseline, improvement
Posted result
| Group | Value (mean), Millimeters of mercury (mmHg) | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26: sBP | -3 | — |
| Week 52: sBP | -0 | — |
| Week 26: dBP | -0 | — |
| Week 52: dBP | -1 | — |
| Oral Semaglutide 7 mgWeek 26: sBP | -5 | — |
| Week 52: sBP | -1 | — |
| Week 26: dBP | -2 | — |
| Week 52: dBP | -0 | — |
| Oral Semaglutide 14 mgWeek 26: sBP | -2 | — |
| Week 52: sBP | -1 | — |
| Week 26: dBP | 1 | — |
| Week 52: dBP | -0 | — |
| Liraglutide 0.9 mgWeek 26: sBP | -1 | — |
| Week 52: sBP | 1 | — |
| Week 26: dBP | -1 | — |
| Week 52: dBP | -0 | — |
| PlaceboWeek 26: sBP | -4 | — |
| Week 52: sBP | -3 | — |
| Week 26: dBP | -3 | — |
| Week 52: dBP | -2 | — |
Change in Total Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
Total cholesterol, change
ratio, improvement
LOINC 2093-3
Change in HDL Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
HDL-C, change
ratio, improvement
LOINC 2085-9
Change in LDL Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
LDL-C, change
ratio, improvement
LOINC 13457-7
Change in VLDL Cholesterol (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
VLDL, change
ratio, improvement
Change in Triglycerides (Ratio to Baseline)
Time frame:Week 0, week 26 and week 52
Triglycerides, change
ratio, improvement
LOINC 2571-8
Change in Pulse Rate
Time frame:Week 0, week 26, week 52
Heart rate, change
change from baseline, improvement
Change in Blood Pressure
Time frame:Week 0, week 26, week 52
change from baseline, improvement
Patient-reported / QoL
10 endpointsChange in SF-36: Sub-domains
Time frame:Week 0, week 26, week 52
change from baseline, improvement
Posted result
| Group | Value (mean), Score on a scale | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26: Physical Functioning | -0.22 | — |
| Week 52: Physical Functioning | -0.31 | — |
| Week 26: Role-Physical | -1.79 | — |
| Week 52: Role-Physical | -2.14 | — |
| Week 26: Bodily Pain | -2.02 | — |
| Week 52: Bodily Pain | -2.43 | — |
| Week 26: General Health | -2.43 | — |
| Week 52: General Health | -0.99 | — |
| Week 26: Vitality | -2.85 | — |
| Week 52: Vitality | -1.93 | — |
| Week 26: Social Functioning | -0.11 | — |
| Week 52: Social Functioning | -0.78 | — |
| Week 26: Role-Emotional | -1.60 | — |
| Week 52: Role-Emotional | -0.70 | — |
| Week 26: Mental Health | -1.90 | — |
| Week 52: Mental Health | -2.41 | — |
| Oral Semaglutide 7 mgWeek 26: Physical Functioning | -0.09 | — |
| Week 52: Physical Functioning | 0.30 | — |
| Week 26: Role-Physical | 0.00 | — |
| Week 52: Role-Physical | 0.15 | — |
| Week 26: Bodily Pain | -0.89 | — |
| Week 52: Bodily Pain | -0.16 | — |
| Week 26: General Health | 0.52 | — |
| Week 52: General Health | -1.24 | — |
| Week 26: Vitality | -0.48 | — |
| Week 52: Vitality | -0.82 | — |
| Week 26: Social Functioning | 0.77 | — |
| Week 52: Social Functioning | -0.58 | — |
| Week 26: Role-Emotional | -0.00 | — |
| Week 52: Role-Emotional | 0.18 | — |
| Week 26: Mental Health | 0.77 | — |
| Week 52: Mental Health | -0.52 | — |
| Oral Semaglutide 14 mgWeek 26: Physical Functioning | 0.04 | — |
| Week 52: Physical Functioning | -0.00 | — |
| Week 26: Role-Physical | 0.05 | — |
| Week 52: Role-Physical | -0.86 | — |
| Week 26: Bodily Pain | 1.18 | — |
| Week 52: Bodily Pain | 0.03 | — |
| Week 26: General Health | 0.41 | — |
| Week 52: General Health | -0.47 | — |
| Week 26: Vitality | -1.49 | — |
| Week 52: Vitality | -1.06 | — |
| Week 26: Social Functioning | -0.45 | — |
| Week 52: Social Functioning | 0.00 | — |
| Week 26: Role-Emotional | 0.35 | — |
| Week 52: Role-Emotional | -0.47 | — |
| Week 26: Mental Health | -2.36 | — |
| Week 52: Mental Health | -1.69 | — |
| Liraglutide 0.9 mgWeek 26: Physical Functioning | 0.09 | — |
| Week 52: Physical Functioning | -0.09 | — |
| Week 26: Role-Physical | 0.10 | — |
| Week 52: Role-Physical | -0.59 | — |
| Week 26: Bodily Pain | 0.48 | — |
| Week 52: Bodily Pain | 0.98 | — |
| Week 26: General Health | -0.00 | — |
| Week 52: General Health | 0.62 | — |
| Week 26: Vitality | -0.18 | — |
| Week 52: Vitality | -0.13 | — |
| Week 26: Social Functioning | -0.66 | — |
| Week 52: Social Functioning | -0.48 | — |
| Week 26: Role-Emotional | -0.09 | — |
| Week 52: Role-Emotional | -0.19 | — |
| Week 26: Mental Health | 1.71 | — |
| Week 52: Mental Health | 0.72 | — |
| PlaceboWeek 26: Physical Functioning | -0.14 | — |
| Week 52: Physical Functioning | -0.00 | — |
| Week 26: Role-Physical | -0.86 | — |
| Week 52: Role-Physical | -0.58 | — |
| Week 26: Bodily Pain | -0.19 | — |
| Week 52: Bodily Pain | -0.79 | — |
| Week 26: General Health | -0.08 | — |
| Week 52: General Health | -0.99 | — |
| Week 26: Vitality | -1.99 | — |
| Week 52: Vitality | -1.60 | — |
| Week 26: Social Functioning | -1.20 | — |
| Week 52: Social Functioning | -1.16 | — |
| Week 26: Role-Emotional | -1.12 | — |
| Week 52: Role-Emotional | -1.80 | — |
| Week 26: Mental Health | -2.17 | — |
| Week 52: Mental Health | -1.31 | — |
Change in SF-36: Physical Component Summary (PCS)
Time frame:Week 0, week 26, week 52
SF-36 physical
change from baseline, improvement
Posted result
| Group | Value (mean), Score on a scale | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | -1.33 | — |
| Week 52 | -1.28 | — |
| Oral Semaglutide 7 mgWeek 26 | -0.38 | — |
| Week 52 | -0.12 | — |
| Oral Semaglutide 14 mgWeek 26 | 0.93 | — |
| Week 52 | 0.02 | — |
| Liraglutide 0.9 mgWeek 26 | -0.14 | — |
| Week 52 | 0.10 | — |
| PlaceboWeek 26 | 0.20 | — |
| Week 52 | -0.10 | — |
Change in SF-36: Mental Component Summary (MCS)
Time frame:Week 0, week 26, week 52
SF-36 mental
change from baseline, improvement
Posted result
| Group | Value (mean), Score on a scale | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | -1.81 | — |
| Week 52 | -1.56 | — |
| Oral Semaglutide 7 mgWeek 26 | 0.56 | — |
| Week 52 | -0.58 | — |
| Oral Semaglutide 14 mgWeek 26 | -1.61 | — |
| Week 52 | -1.16 | — |
| Liraglutide 0.9 mgWeek 26 | 0.49 | — |
| Week 52 | 0.10 | — |
| PlaceboWeek 26 | -2.18 | — |
| Week 52 | -1.94 | — |
Change From Baseline in DTR-QOL: Total Score
Time frame:Week 0, week 26, week 52
change from baseline, improvement
Posted result
| Group | Value (mean), Score on a scale | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 6.67 | — |
| Week 52 | 6.97 | — |
| Oral Semaglutide 7 mgWeek 26 | 7.98 | — |
| Week 52 | 5.52 | — |
| Oral Semaglutide 14 mgWeek 26 | 11.22 | — |
| Week 52 | 8.02 | — |
| Liraglutide 0.9 mgWeek 26 | 9.77 | — |
| Week 52 | 7.12 | — |
| PlaceboWeek 26 | 4.18 | — |
| Week 52 | 0.57 | — |
Change From Baseline in DTR-QOL: Sub-domains
Time frame:Week 0, week 26, week 52
change from baseline, improvement
Posted result
| Group | Value (mean), Score on a scale | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgW26: Burden on social and daily activities | 5.75 | — |
| W52: Burden on social and daily activities | 9.31 | — |
| W26: Anxiety and dissatisfaction with treatment | 6.49 | — |
| W52: Anxiety and dissatisfaction with treatment | 4.93 | — |
| Week 26: Hypoglycemia | 8.33 | — |
| Week 52: Hypoglycemia | 5.81 | — |
| Week 26: Satisfaction with treatment | 8.33 | — |
| Week 52: Satisfaction with treatment | 4.61 | — |
| Oral Semaglutide 7 mgW26: Burden on social and daily activities | 5.87 | — |
| W52: Burden on social and daily activities | 5.49 | — |
| W26: Anxiety and dissatisfaction with treatment | 10.46 | — |
| W52: Anxiety and dissatisfaction with treatment | 5.04 | — |
| Week 26: Hypoglycemia | 3.15 | — |
| Week 52: Hypoglycemia | 1.26 | — |
| Week 26: Satisfaction with treatment | 14.72 | — |
| Week 52: Satisfaction with treatment | 10.85 | — |
| Oral Semaglutide 14 mgW26: Burden on social and daily activities | 7.90 | — |
| W52: Burden on social and daily activities | 3.94 | — |
| W26: Anxiety and dissatisfaction with treatment | 14.68 | — |
| W52: Anxiety and dissatisfaction with treatment | 10.52 | — |
| Week 26: Hypoglycemia | 9.19 | — |
| Week 52: Hypoglycemia | 8.13 | — |
| Week 26: Satisfaction with treatment | 17.14 | — |
| Week 52: Satisfaction with treatment | 16.16 | — |
| Liraglutide 0.9 mgW26: Burden on social and daily activities | 10.11 | — |
| W52: Burden on social and daily activities | 7.60 | — |
| W26: Anxiety and dissatisfaction with treatment | 13.52 | — |
| W52: Anxiety and dissatisfaction with treatment | 7.01 | — |
| Week 26: Hypoglycemia | 3.80 | — |
| Week 52: Hypoglycemia | 4.47 | — |
| Week 26: Satisfaction with treatment | 7.13 | — |
| Week 52: Satisfaction with treatment | 8.43 | — |
| PlaceboW26: Burden on social and daily activities | 6.91 | — |
| W52: Burden on social and daily activities | 2.90 | — |
| W26: Anxiety and dissatisfaction with treatment | 1.83 | — |
| W52: Anxiety and dissatisfaction with treatment | -2.94 | — |
| Week 26: Hypoglycemia | 7.42 | — |
| Week 52: Hypoglycemia | 6.00 | — |
| Week 26: Satisfaction with treatment | -3.25 | — |
| Week 52: Satisfaction with treatment | -5.39 | — |
Change in SF-36: Sub-domains
Time frame:Week 0, week 26, week 52
SF-36 total
change from baseline, improvement
Change in SF-36: Physical Component Summary (PCS)
Time frame:Week 0, week 26, week 52
SF-36 physical
change from baseline, improvement
Change in SF-36: Mental Component Summary (MCS)
Time frame:Week 0, week 26, week 52
SF-36 mental
change from baseline, improvement
Change From Baseline in DTR-QOL: Total Score
Time frame:Week 0, week 26, week 52
change from baseline, improvement
Change From Baseline in DTR-QOL: Sub-domains
Time frame:Week 0, week 26, week 52
change from baseline, improvement
Safety / tolerability / PK
27 endpointsNumber of Treatment-emergent Adverse Events (TEAEs)
Time frame:Weeks 0 - 57
Treatment-emergent AEs (any)
event count, event
Posted result
| Group | Value (number), Adverse events | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mg | 119 | — |
| Oral Semaglutide 7 mg | 111 | — |
| Oral Semaglutide 14 mg | 96 | — |
| Liraglutide 0.9 mg | 116 | — |
| Placebo | 106 | — |
Change in Amylase (Ratio to Baseine)
Time frame:Week 0, week 26, week 52
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of amylase | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 1.03 | — |
| Week 52 | 1.06 | — |
| Oral Semaglutide 7 mgWeek 26 | 1.10 | — |
| Week 52 | 1.10 | — |
| Oral Semaglutide 14 mgWeek 26 | 1.16 | — |
| Week 52 | 1.12 | — |
| Liraglutide 0.9 mgWeek 26 | 1.07 | — |
| Week 52 | 1.06 | — |
| PlaceboWeek 26 | 1.02 | — |
| Week 52 | 1.02 | — |
Change in Lipase (Ratio to Baseine)
Time frame:Week 0, week 26, week 52
ratio, descriptive
Posted result
| Group | Value (geometric_mean), Ratio of lipase | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 | 1.25 | — |
| Week 52 | 1.29 | — |
| Oral Semaglutide 7 mgWeek 26 | 1.35 | — |
| Week 52 | 1.41 | — |
| Oral Semaglutide 14 mgWeek 26 | 1.61 | — |
| Week 52 | 1.47 | — |
| Liraglutide 0.9 mgWeek 26 | 1.47 | — |
| Week 52 | 1.60 | — |
| PlaceboWeek 26 | 1.04 | — |
| Week 52 | 1.03 | — |
Change in ECG Evaluation
Time frame:Week 0, week 26, week 52
categorical status, descriptive
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgNormal (week 0) to normal (week 26) | 34 | — |
| Normal (week 0) to abnormal NCS (week 26) | 4 | — |
| Normal (week 0) to abnormal CS (week 26) | 0 | — |
| Abnormal NCS (week 0) to normal (week 26) | 3 | — |
| Abnormal NCS (week 0) to abnormal NCS (week 26) | 3 | — |
| Abnormal NCS (week 0) to abnormal CS (week 26) | 0 | — |
| Abnormal CS (week 0) to normal (week 26) | 2 | — |
| Abnormal CS (week 0) to abnormal NCS (week 26) | 0 | — |
| Abnormal CS (week 0) to abnormal CS (week 26) | 0 | — |
| Normal (week 0) to normal (week 52) | 37 | — |
| Normal (week 0) to abnormal NCS (week 52) | 1 | — |
| Normal (week 0) to abnormal CS (week 52) | 0 | — |
| Abnormal NCS (week 0) to normal (week 52) | 3 | — |
| Abnormal NCS (week 0) to abnormal NCS (week 52) | 3 | — |
| Abnormal NCS (week 0) to abnormal CS (week 52) | 0 | — |
| Abnormal CS (week 0) to normal (week 52) | 2 | — |
| Abnormal CS (week 0) to abnormal NCS (week 52) | 0 | — |
| Abnormal CS (week 0) to abnormal CS (week 52) | 0 | — |
| Oral Semaglutide 7 mgNormal (week 0) to normal (week 26) | 41 | — |
| Normal (week 0) to abnormal NCS (week 26) | 0 | — |
| Normal (week 0) to abnormal CS (week 26) | 0 | — |
| Abnormal NCS (week 0) to normal (week 26) | 1 | — |
| Abnormal NCS (week 0) to abnormal NCS (week 26) | 5 | — |
| Abnormal NCS (week 0) to abnormal CS (week 26) | 0 | — |
| Abnormal CS (week 0) to normal (week 26) | 0 | — |
| Abnormal CS (week 0) to abnormal NCS (week 26) | 0 | — |
| Abnormal CS (week 0) to abnormal CS (week 26) | 2 | — |
| Normal (week 0) to normal (week 52) | 40 | — |
| Normal (week 0) to abnormal NCS (week 52) | 1 | — |
| Normal (week 0) to abnormal CS (week 52) | 0 | — |
| Abnormal NCS (week 0) to normal (week 52) | 2 | — |
| Abnormal NCS (week 0) to abnormal NCS (week 52) | 4 | — |
| Abnormal NCS (week 0) to abnormal CS (week 52) | 0 | — |
| Abnormal CS (week 0) to normal (week 52) | 0 | — |
| Abnormal CS (week 0) to abnormal NCS (week 52) | 0 | — |
| Abnormal CS (week 0) to abnormal CS (week 52) | 2 | — |
| Oral Semaglutide 14 mgNormal (week 0) to normal (week 26) | 39 | — |
| Normal (week 0) to abnormal NCS (week 26) | 0 | — |
| Normal (week 0) to abnormal CS (week 26) | 0 | — |
| Abnormal NCS (week 0) to normal (week 26) | 3 | — |
| Abnormal NCS (week 0) to abnormal NCS (week 26) | 4 | — |
| Abnormal NCS (week 0) to abnormal CS (week 26) | 0 | — |
| Abnormal CS (week 0) to normal (week 26) | 0 | — |
| Abnormal CS (week 0) to abnormal NCS (week 26) | 0 | — |
| Abnormal CS (week 0) to abnormal CS (week 26) | 1 | — |
| Normal (week 0) to normal (week 52) | 36 | — |
| Normal (week 0) to abnormal NCS (week 52) | 3 | — |
| Normal (week 0) to abnormal CS (week 52) | 0 | — |
| Abnormal NCS (week 0) to normal (week 52) | 2 | — |
| Abnormal NCS (week 0) to abnormal NCS (week 52) | 5 | — |
| Abnormal NCS (week 0) to abnormal CS (week 52) | 0 | — |
| Abnormal CS (week 0) to normal (week 52) | 1 | — |
| Abnormal CS (week 0) to abnormal NCS (week 52) | 0 | — |
| Abnormal CS (week 0) to abnormal CS (week 52) | 0 | — |
| Liraglutide 0.9 mgNormal (week 0) to normal (week 26) | 38 | — |
| Normal (week 0) to abnormal NCS (week 26) | 2 | — |
| Normal (week 0) to abnormal CS (week 26) | 0 | — |
| Abnormal NCS (week 0) to normal (week 26) | 1 | — |
| Abnormal NCS (week 0) to abnormal NCS (week 26) | 4 | — |
| Abnormal NCS (week 0) to abnormal CS (week 26) | 0 | — |
| Abnormal CS (week 0) to normal (week 26) | 0 | — |
| Abnormal CS (week 0) to abnormal NCS (week 26) | 0 | — |
| Abnormal CS (week 0) to abnormal CS (week 26) | 1 | — |
| Normal (week 0) to normal (week 52) | 37 | — |
| Normal (week 0) to abnormal NCS (week 52) | 2 | — |
| Normal (week 0) to abnormal CS (week 52) | 0 | — |
| Abnormal NCS (week 0) to normal (week 52) | 2 | — |
| Abnormal NCS (week 0) to abnormal NCS (week 52) | 3 | — |
| Abnormal NCS (week 0) to abnormal CS (week 52) | 0 | — |
| Abnormal CS (week 0) to normal (week 52) | 0 | — |
| Abnormal CS (week 0) to abnormal NCS (week 52) | 0 | — |
| Abnormal CS (week 0) to abnormal CS (week 52) | 1 | — |
| PlaceboNormal (week 0) to normal (week 26) | 39 | — |
| Normal (week 0) to abnormal NCS (week 26) | 2 | — |
| Normal (week 0) to abnormal CS (week 26) | 0 | — |
| Abnormal NCS (week 0) to normal (week 26) | 1 | — |
| Abnormal NCS (week 0) to abnormal NCS (week 26) | 6 | — |
| Abnormal NCS (week 0) to abnormal CS (week 26) | 0 | — |
| Abnormal CS (week 0) to normal (week 26) | 0 | — |
| Abnormal CS (week 0) to abnormal NCS (week 26) | 1 | — |
| Abnormal CS (week 0) to abnormal CS (week 26) | 0 | — |
| Normal (week 0) to normal (week 52) | 39 | — |
| Normal (week 0) to abnormal NCS (week 52) | 2 | — |
| Normal (week 0) to abnormal CS (week 52) | 0 | — |
| Abnormal NCS (week 0) to normal (week 52) | 3 | — |
| Abnormal NCS (week 0) to abnormal NCS (week 52) | 4 | — |
| Abnormal NCS (week 0) to abnormal CS (week 52) | 0 | — |
| Abnormal CS (week 0) to normal (week 52) | 0 | — |
| Abnormal CS (week 0) to abnormal NCS (week 52) | 1 | — |
| Abnormal CS (week 0) to abnormal CS (week 52) | 0 | — |
Change in Physical Examination
Time frame:Baseline (Week -8), week 26, week 52
categorical status, descriptive
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek -8: Cardiovascular- Normal | 49 | — |
| Week -8: Cardiovascular- Abnormal NCS | 0 | — |
| Week -8: Cardiovascular- Abnormal CS | 0 | — |
| Week 26: Cardiovascular- Normal | 46 | — |
| Week 26: Cardiovascular- Abnormal NCS | 0 | — |
| Week 26: Cardiovascular- Abnormal CS | 0 | — |
| Week 52: Cardiovascular- Normal | 46 | — |
| Week 52: Cardiovascular- Abnormal NCS | 0 | — |
| Week 52: Cardiovascular- Abnormal CS | 0 | — |
| Week -8: Nervous system- Normal | 48 | — |
| Week -8: Nervous system- Abnormal NCS | 1 | — |
| Week -8: Nervous system- Abnormal CS | 0 | — |
| Week 26: Nervous system- Normal | 45 | — |
| Week 26: Nervous system- Abnormal NCS | 1 | — |
| Week 26: Nervous system- Abnormal CS | 0 | — |
| Week 52: Nervous system- Normal | 45 | — |
| Week 52: Nervous system- Abnormal NCS | 1 | — |
| Week 52: Nervous system- Abnormal CS | 0 | — |
| Week -8: Gastrointestinal sys- Normal | 46 | — |
| Week -8: Gastrointestinal sys- Abnormal NCS | 2 | — |
| Week -8: Gastrointestinal sys- Abnormal CS | 1 | — |
| Week 26: Gastrointestinal sys - Normal | 44 | — |
| Week 26: Gastrointestinal sys- Abnormal NCS | 1 | — |
| Week 26: Gastrointestinal sys- Abnormal CS | 1 | — |
| Week 52: Gastrointestinal sys- Normal | 43 | — |
| Week 52: Gastrointestinal sys- Abnormal NCS | 2 | — |
| Week 52: Gastrointestinal sys- Abnormal CS | 1 | — |
| Week -8: General appearance- Normal | 47 | — |
| Week -8: General appearance- Abnormal NCS | 2 | — |
| Week -8: General appearance- Abnormal CS | 0 | — |
| Week 26: General appearance- Normal | 44 | — |
| Week 26: General appearance- Abnormal NCS | 2 | — |
| Week 26: General appearance- Abnormal CS | 0 | — |
| Week 52: General appearance- Normal | 43 | — |
| Week 52: General appearance- Abnormal NCS | 2 | — |
| Week 52: General appearance- Abnormal CS | 1 | — |
| Week -8: Head and neck- Normal | 44 | — |
| Week -8: Head and neck- Abnormal NCS | 5 | — |
| Week -8: Head and neck- Abnormal CS | 0 | — |
| Week 26: Head and neck- Normal | 43 | — |
| Week 26: Head and neck- Abnormal NCS | 3 | — |
| Week 26: Head and neck- Abnormal CS | 0 | — |
| Week 52: Head and neck- Normal | 42 | — |
| Week 52: Head and neck- Abnormal NCS | 4 | — |
| Week 52: Head and neck- Abnormal CS | 0 | — |
| Week -8: Lymph node- Normal | 49 | — |
| Week -8: Lymph node- Abnormal NCS | 0 | — |
| Week -8: Lymph node- Abnormal CS | 0 | — |
| Week 26: Lymph node- Normal | 46 | — |
| Week 26: Lymph node- Abnormal NCS | 0 | — |
| Week 26: Lymph node- Abnormal CS | 0 | — |
| Week 52: Lymph node- Normal | 46 | — |
| Week 52: Lymph node- Abnormal NCS | 0 | — |
| Week 52: Lymph node- Abnormal CS | 0 | — |
| Week -8: Musculoskeletal- Normal | 47 | — |
| Week -8: Musculoskeletal- Abnormal NCS | 2 | — |
| Week -8: Musculoskeletal- Abnormal CS | 0 | — |
| Week 26: Musculoskeletal- Normal | 42 | — |
| Week 26: Musculoskeletal- Abnormal NCS | 4 | — |
| Week 26: Musculoskeletal- Abnormal CS | 0 | — |
| Week 52: Musculoskeletal- Normal | 41 | — |
| Week 52: Musculoskeletal- Abnormal NCS | 5 | — |
| Week 52: Musculoskeletal- Abnormal CS | 0 | — |
| Week -8: Respiratory sys- Normal | 49 | — |
| Week -8: Respiratory sys- Abnormal NCS | 0 | — |
| Week -8: Respiratory sys- Abnormal CS | 0 | — |
| Week 26: Respiratory sys- Normal | 46 | — |
| Week 26: Respiratory sys- Abnormal NCS | 0 | — |
| Week 26: Respiratory sys- Abnormal CS | 0 | — |
| Week 52: Respiratory sys- Normal | 46 | — |
| Week 52: Respiratory sys- Abnormal NCS | 0 | — |
| Week 52: Respiratory sys- Abnormal CS | 0 | — |
| Week -8: Skin- Normal | 46 | — |
| Week -8: Skin- Abnormal NCS | 2 | — |
| Week -8: Skin- Abnormal CS | 1 | — |
| Week 26: Skin- Normal | 44 | — |
| Week 26: Skin- Abnormal NCS | 1 | — |
| Week 26: Skin- Abnormal CS | 1 | — |
| Week 52: Skin- Normal | 44 | — |
| Week 52: Skin- Abnormal NCS | 1 | — |
| Week 52: Skin- Abnormal CS | 1 | — |
| Week -8: Thyroid - Normal | 48 | — |
| Week -8: Thyroid- Abnormal NCS | 1 | — |
| Week -8: Thyroid- Abnormal CS | 0 | — |
| Week 26: Thyroid- Normal | 45 | — |
| Week 26: Thyroid- Abnormal NCS | 1 | — |
| Week 26: Thyroid- Abnormal CS | 0 | — |
| Week 52: Thyroid- Normal | 45 | — |
| Week 52: Thyroid- Abnormal NCS | 1 | — |
| Week 52: Thyroid- Abnormal CS | 0 | — |
| Oral Semaglutide 7 mgWeek -8: Cardiovascular- Normal | 49 | — |
| Week -8: Cardiovascular- Abnormal NCS | 0 | — |
| Week -8: Cardiovascular- Abnormal CS | 0 | — |
| Week 26: Cardiovascular- Normal | 49 | — |
| Week 26: Cardiovascular- Abnormal NCS | 0 | — |
| Week 26: Cardiovascular- Abnormal CS | 0 | — |
| Week 52: Cardiovascular- Normal | 49 | — |
| Week 52: Cardiovascular- Abnormal NCS | 0 | — |
| Week 52: Cardiovascular- Abnormal CS | 0 | — |
| Week -8: Nervous system- Normal | 48 | — |
| Week -8: Nervous system- Abnormal NCS | 0 | — |
| Week -8: Nervous system- Abnormal CS | 1 | — |
| Week 26: Nervous system- Normal | 48 | — |
| Week 26: Nervous system- Abnormal NCS | 0 | — |
| Week 26: Nervous system- Abnormal CS | 1 | — |
| Week 52: Nervous system- Normal | 48 | — |
| Week 52: Nervous system- Abnormal NCS | 0 | — |
| Week 52: Nervous system- Abnormal CS | 1 | — |
| Week -8: Gastrointestinal sys- Normal | 47 | — |
| Week -8: Gastrointestinal sys- Abnormal NCS | 1 | — |
| Week -8: Gastrointestinal sys- Abnormal CS | 1 | — |
| Week 26: Gastrointestinal sys - Normal | 47 | — |
| Week 26: Gastrointestinal sys- Abnormal NCS | 1 | — |
| Week 26: Gastrointestinal sys- Abnormal CS | 1 | — |
| Week 52: Gastrointestinal sys- Normal | 45 | — |
| Week 52: Gastrointestinal sys- Abnormal NCS | 3 | — |
| Week 52: Gastrointestinal sys- Abnormal CS | 1 | — |
| Week -8: General appearance- Normal | 47 | — |
| Week -8: General appearance- Abnormal NCS | 2 | — |
| Week -8: General appearance- Abnormal CS | 0 | — |
| Week 26: General appearance- Normal | 47 | — |
| Week 26: General appearance- Abnormal NCS | 2 | — |
| Week 26: General appearance- Abnormal CS | 0 | — |
| Week 52: General appearance- Normal | 48 | — |
| Week 52: General appearance- Abnormal NCS | 1 | — |
| Week 52: General appearance- Abnormal CS | 0 | — |
| Week -8: Head and neck- Normal | 45 | — |
| Week -8: Head and neck- Abnormal NCS | 1 | — |
| Week -8: Head and neck- Abnormal CS | 3 | — |
| Week 26: Head and neck- Normal | 47 | — |
| Week 26: Head and neck- Abnormal NCS | 0 | — |
| Week 26: Head and neck- Abnormal CS | 2 | — |
| Week 52: Head and neck- Normal | 47 | — |
| Week 52: Head and neck- Abnormal NCS | 0 | — |
| Week 52: Head and neck- Abnormal CS | 2 | — |
| Week -8: Lymph node- Normal | 49 | — |
| Week -8: Lymph node- Abnormal NCS | 0 | — |
| Week -8: Lymph node- Abnormal CS | 0 | — |
| Week 26: Lymph node- Normal | 49 | — |
| Week 26: Lymph node- Abnormal NCS | 0 | — |
| Week 26: Lymph node- Abnormal CS | 0 | — |
| Week 52: Lymph node- Normal | 49 | — |
| Week 52: Lymph node- Abnormal NCS | 0 | — |
| Week 52: Lymph node- Abnormal CS | 0 | — |
| Week -8: Musculoskeletal- Normal | 44 | — |
| Week -8: Musculoskeletal- Abnormal NCS | 3 | — |
| Week -8: Musculoskeletal- Abnormal CS | 2 | — |
| Week 26: Musculoskeletal- Normal | 45 | — |
| Week 26: Musculoskeletal- Abnormal NCS | 2 | — |
| Week 26: Musculoskeletal- Abnormal CS | 2 | — |
| Week 52: Musculoskeletal- Normal | 45 | — |
| Week 52: Musculoskeletal- Abnormal NCS | 2 | — |
| Week 52: Musculoskeletal- Abnormal CS | 2 | — |
| Week -8: Respiratory sys- Normal | 49 | — |
| Week -8: Respiratory sys- Abnormal NCS | 0 | — |
| Week -8: Respiratory sys- Abnormal CS | 0 | — |
| Week 26: Respiratory sys- Normal | 48 | — |
| Week 26: Respiratory sys- Abnormal NCS | 1 | — |
| Week 26: Respiratory sys- Abnormal CS | 0 | — |
| Week 52: Respiratory sys- Normal | 49 | — |
| Week 52: Respiratory sys- Abnormal NCS | 0 | — |
| Week 52: Respiratory sys- Abnormal CS | 0 | — |
| Week -8: Skin- Normal | 48 | — |
| Week -8: Skin- Abnormal NCS | 1 | — |
| Week -8: Skin- Abnormal CS | 0 | — |
| Week 26: Skin- Normal | 47 | — |
| Week 26: Skin- Abnormal NCS | 1 | — |
| Week 26: Skin- Abnormal CS | 1 | — |
| Week 52: Skin- Normal | 47 | — |
| Week 52: Skin- Abnormal NCS | 1 | — |
| Week 52: Skin- Abnormal CS | 1 | — |
| Week -8: Thyroid - Normal | 48 | — |
| Week -8: Thyroid- Abnormal NCS | 0 | — |
| Week -8: Thyroid- Abnormal CS | 1 | — |
| Week 26: Thyroid- Normal | 48 | — |
| Week 26: Thyroid- Abnormal NCS | 0 | — |
| Week 26: Thyroid- Abnormal CS | 1 | — |
| Week 52: Thyroid- Normal | 48 | — |
| Week 52: Thyroid- Abnormal NCS | 0 | — |
| Week 52: Thyroid- Abnormal CS | 1 | — |
| Oral Semaglutide 14 mgWeek -8: Cardiovascular- Normal | 48 | — |
| Week -8: Cardiovascular- Abnormal NCS | 0 | — |
| Week -8: Cardiovascular- Abnormal CS | 0 | — |
| Week 26: Cardiovascular- Normal | 47 | — |
| Week 26: Cardiovascular- Abnormal NCS | 0 | — |
| Week 26: Cardiovascular- Abnormal CS | 0 | — |
| Week 52: Cardiovascular- Normal | 47 | — |
| Week 52: Cardiovascular- Abnormal NCS | 0 | — |
| Week 52: Cardiovascular- Abnormal CS | 0 | — |
| Week -8: Nervous system- Normal | 48 | — |
| Week -8: Nervous system- Abnormal NCS | 0 | — |
| Week -8: Nervous system- Abnormal CS | 0 | — |
| Week 26: Nervous system- Normal | 47 | — |
| Week 26: Nervous system- Abnormal NCS | 0 | — |
| Week 26: Nervous system- Abnormal CS | 0 | — |
| Week 52: Nervous system- Normal | 47 | — |
| Week 52: Nervous system- Abnormal NCS | 0 | — |
| Week 52: Nervous system- Abnormal CS | 0 | — |
| Week -8: Gastrointestinal sys- Normal | 47 | — |
| Week -8: Gastrointestinal sys- Abnormal NCS | 0 | — |
| Week -8: Gastrointestinal sys- Abnormal CS | 1 | — |
| Week 26: Gastrointestinal sys - Normal | 45 | — |
| Week 26: Gastrointestinal sys- Abnormal NCS | 1 | — |
| Week 26: Gastrointestinal sys- Abnormal CS | 1 | — |
| Week 52: Gastrointestinal sys- Normal | 45 | — |
| Week 52: Gastrointestinal sys- Abnormal NCS | 1 | — |
| Week 52: Gastrointestinal sys- Abnormal CS | 1 | — |
| Week -8: General appearance- Normal | 47 | — |
| Week -8: General appearance- Abnormal NCS | 1 | — |
| Week -8: General appearance- Abnormal CS | 0 | — |
| Week 26: General appearance- Normal | 45 | — |
| Week 26: General appearance- Abnormal NCS | 2 | — |
| Week 26: General appearance- Abnormal CS | 0 | — |
| Week 52: General appearance- Normal | 46 | — |
| Week 52: General appearance- Abnormal NCS | 1 | — |
| Week 52: General appearance- Abnormal CS | 0 | — |
| Week -8: Head and neck- Normal | 44 | — |
| Week -8: Head and neck- Abnormal NCS | 1 | — |
| Week -8: Head and neck- Abnormal CS | 3 | — |
| Week 26: Head and neck- Normal | 43 | — |
| Week 26: Head and neck- Abnormal NCS | 1 | — |
| Week 26: Head and neck- Abnormal CS | 3 | — |
| Week 52: Head and neck- Normal | 43 | — |
| Week 52: Head and neck- Abnormal NCS | 2 | — |
| Week 52: Head and neck- Abnormal CS | 2 | — |
| Week -8: Lymph node- Normal | 48 | — |
| Week -8: Lymph node- Abnormal NCS | 0 | — |
| Week -8: Lymph node- Abnormal CS | 0 | — |
| Week 26: Lymph node- Normal | 47 | — |
| Week 26: Lymph node- Abnormal NCS | 0 | — |
| Week 26: Lymph node- Abnormal CS | 0 | — |
| Week 52: Lymph node- Normal | 47 | — |
| Week 52: Lymph node- Abnormal NCS | 0 | — |
| Week 52: Lymph node- Abnormal CS | 0 | — |
| Week -8: Musculoskeletal- Normal | 47 | — |
| Week -8: Musculoskeletal- Abnormal NCS | 0 | — |
| Week -8: Musculoskeletal- Abnormal CS | 1 | — |
| Week 26: Musculoskeletal- Normal | 46 | — |
| Week 26: Musculoskeletal- Abnormal NCS | 0 | — |
| Week 26: Musculoskeletal- Abnormal CS | 1 | — |
| Week 52: Musculoskeletal- Normal | 46 | — |
| Week 52: Musculoskeletal- Abnormal NCS | 0 | — |
| Week 52: Musculoskeletal- Abnormal CS | 1 | — |
| Week -8: Respiratory sys- Normal | 46 | — |
| Week -8: Respiratory sys- Abnormal NCS | 0 | — |
| Week -8: Respiratory sys- Abnormal CS | 2 | — |
| Week 26: Respiratory sys- Normal | 45 | — |
| Week 26: Respiratory sys- Abnormal NCS | 0 | — |
| Week 26: Respiratory sys- Abnormal CS | 2 | — |
| Week 52: Respiratory sys- Normal | 45 | — |
| Week 52: Respiratory sys- Abnormal NCS | 0 | — |
| Week 52: Respiratory sys- Abnormal CS | 2 | — |
| Week -8: Skin- Normal | 45 | — |
| Week -8: Skin- Abnormal NCS | 0 | — |
| Week -8: Skin- Abnormal CS | 3 | — |
| Week 26: Skin- Normal | 44 | — |
| Week 26: Skin- Abnormal NCS | 0 | — |
| Week 26: Skin- Abnormal CS | 3 | — |
| Week 52: Skin- Normal | 44 | — |
| Week 52: Skin- Abnormal NCS | 0 | — |
| Week 52: Skin- Abnormal CS | 3 | — |
| Week -8: Thyroid - Normal | 48 | — |
| Week -8: Thyroid- Abnormal NCS | 0 | — |
| Week -8: Thyroid- Abnormal CS | 0 | — |
| Week 26: Thyroid- Normal | 47 | — |
| Week 26: Thyroid- Abnormal NCS | 0 | — |
| Week 26: Thyroid- Abnormal CS | 0 | — |
| Week 52: Thyroid- Normal | 47 | — |
| Week 52: Thyroid- Abnormal NCS | 0 | — |
| Week 52: Thyroid- Abnormal CS | 0 | — |
| Liraglutide 0.9 mgWeek -8: Cardiovascular- Normal | 48 | — |
| Week -8: Cardiovascular- Abnormal NCS | 0 | — |
| Week -8: Cardiovascular- Abnormal CS | 0 | — |
| Week 26: Cardiovascular- Normal | 45 | — |
| Week 26: Cardiovascular- Abnormal NCS | 0 | — |
| Week 26: Cardiovascular- Abnormal CS | 0 | — |
| Week 52: Cardiovascular- Normal | 45 | — |
| Week 52: Cardiovascular- Abnormal NCS | 0 | — |
| Week 52: Cardiovascular- Abnormal CS | 0 | — |
| Week -8: Nervous system- Normal | 48 | — |
| Week -8: Nervous system- Abnormal NCS | 0 | — |
| Week -8: Nervous system- Abnormal CS | 0 | — |
| Week 26: Nervous system- Normal | 45 | — |
| Week 26: Nervous system- Abnormal NCS | 0 | — |
| Week 26: Nervous system- Abnormal CS | 0 | — |
| Week 52: Nervous system- Normal | 45 | — |
| Week 52: Nervous system- Abnormal NCS | 0 | — |
| Week 52: Nervous system- Abnormal CS | 0 | — |
| Week -8: Gastrointestinal sys- Normal | 47 | — |
| Week -8: Gastrointestinal sys- Abnormal NCS | 0 | — |
| Week -8: Gastrointestinal sys- Abnormal CS | 1 | — |
| Week 26: Gastrointestinal sys - Normal | 44 | — |
| Week 26: Gastrointestinal sys- Abnormal NCS | 0 | — |
| Week 26: Gastrointestinal sys- Abnormal CS | 1 | — |
| Week 52: Gastrointestinal sys- Normal | 44 | — |
| Week 52: Gastrointestinal sys- Abnormal NCS | 0 | — |
| Week 52: Gastrointestinal sys- Abnormal CS | 1 | — |
| Week -8: General appearance- Normal | 47 | — |
| Week -8: General appearance- Abnormal NCS | 1 | — |
| Week -8: General appearance- Abnormal CS | 0 | — |
| Week 26: General appearance- Normal | 44 | — |
| Week 26: General appearance- Abnormal NCS | 1 | — |
| Week 26: General appearance- Abnormal CS | 0 | — |
| Week 52: General appearance- Normal | 44 | — |
| Week 52: General appearance- Abnormal NCS | 1 | — |
| Week 52: General appearance- Abnormal CS | 0 | — |
| Week -8: Head and neck- Normal | 45 | — |
| Week -8: Head and neck- Abnormal NCS | 3 | — |
| Week -8: Head and neck- Abnormal CS | 0 | — |
| Week 26: Head and neck- Normal | 44 | — |
| Week 26: Head and neck- Abnormal NCS | 1 | — |
| Week 26: Head and neck- Abnormal CS | 0 | — |
| Week 52: Head and neck- Normal | 44 | — |
| Week 52: Head and neck- Abnormal NCS | 1 | — |
| Week 52: Head and neck- Abnormal CS | 0 | — |
| Week -8: Lymph node- Normal | 48 | — |
| Week -8: Lymph node- Abnormal NCS | 0 | — |
| Week -8: Lymph node- Abnormal CS | 0 | — |
| Week 26: Lymph node- Normal | 45 | — |
| Week 26: Lymph node- Abnormal NCS | 0 | — |
| Week 26: Lymph node- Abnormal CS | 0 | — |
| Week 52: Lymph node- Normal | 45 | — |
| Week 52: Lymph node- Abnormal NCS | 0 | — |
| Week 52: Lymph node- Abnormal CS | 0 | — |
| Week -8: Musculoskeletal- Normal | 48 | — |
| Week -8: Musculoskeletal- Abnormal NCS | 0 | — |
| Week -8: Musculoskeletal- Abnormal CS | 0 | — |
| Week 26: Musculoskeletal- Normal | 43 | — |
| Week 26: Musculoskeletal- Abnormal NCS | 1 | — |
| Week 26: Musculoskeletal- Abnormal CS | 1 | — |
| Week 52: Musculoskeletal- Normal | 45 | — |
| Week 52: Musculoskeletal- Abnormal NCS | 0 | — |
| Week 52: Musculoskeletal- Abnormal CS | 0 | — |
| Week -8: Respiratory sys- Normal | 47 | — |
| Week -8: Respiratory sys- Abnormal NCS | 1 | — |
| Week -8: Respiratory sys- Abnormal CS | 0 | — |
| Week 26: Respiratory sys- Normal | 44 | — |
| Week 26: Respiratory sys- Abnormal NCS | 1 | — |
| Week 26: Respiratory sys- Abnormal CS | 0 | — |
| Week 52: Respiratory sys- Normal | 44 | — |
| Week 52: Respiratory sys- Abnormal NCS | 1 | — |
| Week 52: Respiratory sys- Abnormal CS | 0 | — |
| Week -8: Skin- Normal | 47 | — |
| Week -8: Skin- Abnormal NCS | 1 | — |
| Week -8: Skin- Abnormal CS | 0 | — |
| Week 26: Skin- Normal | 43 | — |
| Week 26: Skin- Abnormal NCS | 1 | — |
| Week 26: Skin- Abnormal CS | 1 | — |
| Week 52: Skin- Normal | 45 | — |
| Week 52: Skin- Abnormal NCS | 0 | — |
| Week 52: Skin- Abnormal CS | 0 | — |
| Week -8: Thyroid - Normal | 48 | — |
| Week -8: Thyroid- Abnormal NCS | 0 | — |
| Week -8: Thyroid- Abnormal CS | 0 | — |
| Week 26: Thyroid- Normal | 45 | — |
| Week 26: Thyroid- Abnormal NCS | 0 | — |
| Week 26: Thyroid- Abnormal CS | 0 | — |
| Week 52: Thyroid- Normal | 45 | — |
| Week 52: Thyroid- Abnormal NCS | 0 | — |
| Week 52: Thyroid- Abnormal CS | 0 | — |
| PlaceboWeek -8: Cardiovascular- Normal | 49 | — |
| Week -8: Cardiovascular- Abnormal NCS | 0 | — |
| Week -8: Cardiovascular- Abnormal CS | 0 | — |
| Week 26: Cardiovascular- Normal | 49 | — |
| Week 26: Cardiovascular- Abnormal NCS | 0 | — |
| Week 26: Cardiovascular- Abnormal CS | 0 | — |
| Week 52: Cardiovascular- Normal | 49 | — |
| Week 52: Cardiovascular- Abnormal NCS | 0 | — |
| Week 52: Cardiovascular- Abnormal CS | 0 | — |
| Week -8: Nervous system- Normal | 48 | — |
| Week -8: Nervous system- Abnormal NCS | 1 | — |
| Week -8: Nervous system- Abnormal CS | 0 | — |
| Week 26: Nervous system- Normal | 48 | — |
| Week 26: Nervous system- Abnormal NCS | 1 | — |
| Week 26: Nervous system- Abnormal CS | 0 | — |
| Week 52: Nervous system- Normal | 48 | — |
| Week 52: Nervous system- Abnormal NCS | 1 | — |
| Week 52: Nervous system- Abnormal CS | 0 | — |
| Week -8: Gastrointestinal sys- Normal | 48 | — |
| Week -8: Gastrointestinal sys- Abnormal NCS | 1 | — |
| Week -8: Gastrointestinal sys- Abnormal CS | 0 | — |
| Week 26: Gastrointestinal sys - Normal | 48 | — |
| Week 26: Gastrointestinal sys- Abnormal NCS | 1 | — |
| Week 26: Gastrointestinal sys- Abnormal CS | 0 | — |
| Week 52: Gastrointestinal sys- Normal | 47 | — |
| Week 52: Gastrointestinal sys- Abnormal NCS | 2 | — |
| Week 52: Gastrointestinal sys- Abnormal CS | 0 | — |
| Week -8: General appearance- Normal | 46 | — |
| Week -8: General appearance- Abnormal NCS | 3 | — |
| Week -8: General appearance- Abnormal CS | 0 | — |
| Week 26: General appearance- Normal | 46 | — |
| Week 26: General appearance- Abnormal NCS | 3 | — |
| Week 26: General appearance- Abnormal CS | 0 | — |
| Week 52: General appearance- Normal | 46 | — |
| Week 52: General appearance- Abnormal NCS | 3 | — |
| Week 52: General appearance- Abnormal CS | 0 | — |
| Week -8: Head and neck- Normal | 46 | — |
| Week -8: Head and neck- Abnormal NCS | 3 | — |
| Week -8: Head and neck- Abnormal CS | 0 | — |
| Week 26: Head and neck- Normal | 44 | — |
| Week 26: Head and neck- Abnormal NCS | 3 | — |
| Week 26: Head and neck- Abnormal CS | 2 | — |
| Week 52: Head and neck- Normal | 44 | — |
| Week 52: Head and neck- Abnormal NCS | 3 | — |
| Week 52: Head and neck- Abnormal CS | 2 | — |
| Week -8: Lymph node- Normal | 49 | — |
| Week -8: Lymph node- Abnormal NCS | 0 | — |
| Week -8: Lymph node- Abnormal CS | 0 | — |
| Week 26: Lymph node- Normal | 49 | — |
| Week 26: Lymph node- Abnormal NCS | 0 | — |
| Week 26: Lymph node- Abnormal CS | 0 | — |
| Week 52: Lymph node- Normal | 49 | — |
| Week 52: Lymph node- Abnormal NCS | 0 | — |
| Week 52: Lymph node- Abnormal CS | 0 | — |
| Week -8: Musculoskeletal- Normal | 44 | — |
| Week -8: Musculoskeletal- Abnormal NCS | 4 | — |
| Week -8: Musculoskeletal- Abnormal CS | 1 | — |
| Week 26: Musculoskeletal- Normal | 42 | — |
| Week 26: Musculoskeletal- Abnormal NCS | 6 | — |
| Week 26: Musculoskeletal- Abnormal CS | 1 | — |
| Week 52: Musculoskeletal- Normal | 43 | — |
| Week 52: Musculoskeletal- Abnormal NCS | 6 | — |
| Week 52: Musculoskeletal- Abnormal CS | 0 | — |
| Week -8: Respiratory sys- Normal | 49 | — |
| Week -8: Respiratory sys- Abnormal NCS | 0 | — |
| Week -8: Respiratory sys- Abnormal CS | 0 | — |
| Week 26: Respiratory sys- Normal | 49 | — |
| Week 26: Respiratory sys- Abnormal NCS | 0 | — |
| Week 26: Respiratory sys- Abnormal CS | 0 | — |
| Week 52: Respiratory sys- Normal | 49 | — |
| Week 52: Respiratory sys- Abnormal NCS | 0 | — |
| Week 52: Respiratory sys- Abnormal CS | 0 | — |
| Week -8: Skin- Normal | 45 | — |
| Week -8: Skin- Abnormal NCS | 2 | — |
| Week -8: Skin- Abnormal CS | 2 | — |
| Week 26: Skin- Normal | 45 | — |
| Week 26: Skin- Abnormal NCS | 2 | — |
| Week 26: Skin- Abnormal CS | 2 | — |
| Week 52: Skin- Normal | 46 | — |
| Week 52: Skin- Abnormal NCS | 2 | — |
| Week 52: Skin- Abnormal CS | 1 | — |
| Week -8: Thyroid - Normal | 49 | — |
| Week -8: Thyroid- Abnormal NCS | 0 | — |
| Week -8: Thyroid- Abnormal CS | 0 | — |
| Week 26: Thyroid- Normal | 49 | — |
| Week 26: Thyroid- Abnormal NCS | 0 | — |
| Week 26: Thyroid- Abnormal CS | 0 | — |
| Week 52: Thyroid- Normal | 49 | — |
| Week 52: Thyroid- Abnormal NCS | 0 | — |
| Week 52: Thyroid- Abnormal CS | 0 | — |
Change in Eye Examination Category
Time frame:Week -8, Week 52
categorical status, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek -8: Left eye- Normal | 39 | — |
| Week -8: Left eye- Abnormal NCS | 4 | — |
| Week -8: Left eye- Abnormal CS | 6 | — |
| Week 52: Left eye- Normal | 36 | — |
| Week 52: Left eye- Abnormal NCS | 4 | — |
| Week 52: Left eye- Abnormal CS | 6 | — |
| Week -8: Right eye- Normal | 42 | — |
| Week -8: Right eye- Abnormal NCS | 2 | — |
| Week -8: Right eye- Abnormal CS | 5 | — |
| Week 52: Right eye- Normal | 39 | — |
| Week 52: Right eye- Abnormal NCS | 2 | — |
| Week 52: Right eye- Abnormal CS | 5 | — |
| Oral Semaglutide 7 mgWeek -8: Left eye- Normal | 45 | — |
| Week -8: Left eye- Abnormal NCS | 2 | — |
| Week -8: Left eye- Abnormal CS | 2 | — |
| Week 52: Left eye- Normal | 46 | — |
| Week 52: Left eye- Abnormal NCS | 2 | — |
| Week 52: Left eye- Abnormal CS | 1 | — |
| Week -8: Right eye- Normal | 46 | — |
| Week -8: Right eye- Abnormal NCS | 2 | — |
| Week -8: Right eye- Abnormal CS | 1 | — |
| Week 52: Right eye- Normal | 44 | — |
| Week 52: Right eye- Abnormal NCS | 2 | — |
| Week 52: Right eye- Abnormal CS | 3 | — |
| Oral Semaglutide 14 mgWeek -8: Left eye- Normal | 37 | — |
| Week -8: Left eye- Abnormal NCS | 4 | — |
| Week -8: Left eye- Abnormal CS | 7 | — |
| Week 52: Left eye- Normal | 38 | — |
| Week 52: Left eye- Abnormal NCS | 5 | — |
| Week 52: Left eye- Abnormal CS | 4 | — |
| Week -8: Right eye- Normal | 36 | — |
| Week -8: Right eye- Abnormal NCS | 5 | — |
| Week -8: Right eye- Abnormal CS | 7 | — |
| Week 52: Right eye- Normal | 36 | — |
| Week 52: Right eye- Abnormal NCS | 7 | — |
| Week 52: Right eye- Abnormal CS | 4 | — |
| Liraglutide 0.9 mgWeek -8: Left eye- Normal | 37 | — |
| Week -8: Left eye- Abnormal NCS | 6 | — |
| Week -8: Left eye- Abnormal CS | 5 | — |
| Week 52: Left eye- Normal | 37 | — |
| Week 52: Left eye- Abnormal NCS | 5 | — |
| Week 52: Left eye- Abnormal CS | 3 | — |
| Week -8: Right eye- Normal | 38 | — |
| Week -8: Right eye- Abnormal NCS | 7 | — |
| Week -8: Right eye- Abnormal CS | 3 | — |
| Week 52: Right eye- Normal | 39 | — |
| Week 52: Right eye- Abnormal NCS | 5 | — |
| Week 52: Right eye- Abnormal CS | 1 | — |
| PlaceboWeek -8: Left eye- Normal | 39 | — |
| Week -8: Left eye- Abnormal NCS | 5 | — |
| Week -8: Left eye- Abnormal CS | 5 | — |
| Week 52: Left eye- Normal | 41 | — |
| Week 52: Left eye- Abnormal NCS | 3 | — |
| Week 52: Left eye- Abnormal CS | 5 | — |
| Week -8: Right eye- Normal | 39 | — |
| Week -8: Right eye- Abnormal NCS | 4 | — |
| Week -8: Right eye- Abnormal CS | 6 | — |
| Week 52: Right eye- Normal | 44 | — |
| Week 52: Right eye- Abnormal NCS | 3 | — |
| Week 52: Right eye- Abnormal CS | 2 | — |
Anti-semaglutide Binding Antibodies (Yes/no)
Time frame:Week 0 - 57
Immunogenicity (ADA)
categorical status, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgYes | 0 | — |
| No | 49 | — |
| Oral Semaglutide 7 mgYes | 1 | — |
| No | 48 | — |
| Oral Semaglutide 14 mgYes | 1 | — |
| No | 47 | — |
Anti-semaglutide Neutralising Antibodies (Yes/no)
Time frame:Week 0 - 57
Immunogenicity (ADA)
categorical status, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgYes | 0 | — |
| No | 49 | — |
| Oral Semaglutide 7 mgYes | 0 | — |
| No | 49 | — |
| Oral Semaglutide 14 mgYes | 0 | — |
| No | 48 | — |
Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Time frame:Week 0 - 57
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgYes | 0 | — |
| No | 49 | — |
| Oral Semaglutide 7 mgYes | 0 | — |
| No | 49 | — |
| Oral Semaglutide 14 mgYes | 1 | — |
| No | 47 | — |
Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Time frame:Week 0 - 57
Immunogenicity (ADA)
threshold achievement, event
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgYes | 0 | — |
| No | 49 | — |
| Oral Semaglutide 7 mgYes | 0 | — |
| No | 49 | — |
| Oral Semaglutide 14 mgYes | 0 | — |
| No | 48 | — |
Anti-semaglutide Binding Antibody Levels
Time frame:Weeks 0-57
Immunogenicity (ADA)
descriptive
Posted result
| Group | Value (mean), %B/T | 95% CI |
|---|---|---|
| Oral Semaglutide 7 mgWeek 8 | 1.58 | — |
| Oral Semaglutide 14 mgWeek 38 | 2.40 | — |
Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
Time frame:Week 0 - 57
Documented hypoglycemia
event count, event
componentsSevere hypoglycemia, Documented hypoglycemia
Posted result
| Group | Value (number), Episodes | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mg | 0 | — |
| Oral Semaglutide 7 mg | 0 | — |
| Oral Semaglutide 14 mg | 0 | — |
| Liraglutide 0.9 mg | 2 | — |
| Placebo | 0 | — |
Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
Time frame:Weeks 0 - 57
Documented hypoglycemia
threshold achievement, event
componentsSevere hypoglycemia, Documented hypoglycemia
Posted result
| Group | Value (count_of_participants), Participants | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mg | 0 | — |
| Oral Semaglutide 7 mg | 0 | — |
| Oral Semaglutide 14 mg | 0 | — |
| Liraglutide 0.9 mg | 2 | — |
| Placebo | 0 | — |
Semaglutide Plasma Concentration
Time frame:Week 26 and week 52
Plasma concentration (steady state)
concentration, descriptive
Posted result
| Group | Value (geometric_mean), Nanomoles per liter (nmol/L) | 95% CI |
|---|---|---|
| Oral Semaglutide 3 mgWeek 26 pre-dose | 3.7 | — |
| Week 26 post-dose | 5.3 | — |
| Week 52 | 3.2 | — |
| Oral Semaglutide 7 mgWeek 26 pre-dose | 9.5 | — |
| Week 26 post-dose | 13.9 | — |
| Week 52 | 9.2 | — |
| Oral Semaglutide 14 mgWeek 26 pre-dose | 20.6 | — |
| Week 26 post-dose | 30.7 | — |
| Week 52 | 20.0 | — |
Number of Treatment-emergent Adverse Events (TEAEs)
Time frame:Weeks 0 - 57
Treatment-emergent AEs (any)
event count, event
Change in Amylase (Ratio to Baseine)
Time frame:Week 0, week 26, week 52
ratio, descriptive
Change in Lipase (Ratio to Baseine)
Time frame:Week 0, week 26, week 52
ratio, descriptive
Change in ECG Evaluation
Time frame:Week 0, week 26, week 52
categorical status, descriptive
Change in Physical Examination
Time frame:Baseline (Week -8), week 26, week 52
categorical status, descriptive
Anti-semaglutide Binding Antibodies (Yes/no)
Time frame:Week 0 - 57
Immunogenicity (ADA)
categorical status, event
Anti-semaglutide Neutralising Antibodies (Yes/no)
Time frame:Week 0 - 57
Immunogenicity (ADA)
categorical status, event
Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Time frame:Week 0 - 57
Immunogenicity (ADA)
categorical status, event
Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)
Time frame:Week 0 - 57
Immunogenicity (ADA)
categorical status, event
Anti-semaglutide Binding Antibody Levels
Time frame:Weeks 0-57
Immunogenicity (ADA)
descriptive
Number of Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
Time frame:Week 0 - 57
Documented hypoglycemia
event count, event
componentsSevere hypoglycemia, Documented hypoglycemia
Participants With Treatment-emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemic Episodes
Time frame:Weeks 0 - 57
Documented hypoglycemia
threshold achievement, event
componentsSevere hypoglycemia, Documented hypoglycemia
Semaglutide Plasma Concentration
Time frame:Week 26 and week 52
Plasma concentration (steady state)
concentration, descriptive
Other clinical outcomes
1 endpointChange in Eye Examination Category
Time frame:Week -8, Week 52
categorical status, descriptive
Publications (4)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- Cardiovascular diabetology2020 Sep 30PMID32998732doi:10.1186/s12933-020-01106-4via clinicaltrials gov reference derived + pubmed nct search
- Diabetes, obesity & metabolism2020 Aug (month)PMID32267058doi:10.1111/dom.14054via clinicaltrials gov reference derived + pubmed nct search
- The lancet. Diabetes & endocrinology2020 May (month)PMID32333875doi:10.1016/S2213-8587(20)30075-9via clinicaltrials gov reference derived + pubmed nct search
- Diabetes, obesity & metabolism2020 Mar (month)PMID31903692doi:10.1111/dom.13955via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.