Skip to main content
Delfa

← All trials/NCT03018028

PIONEER 9

CompletedPhase 3Results posted

Dose-response, Safety and Efficacy of Oral Semaglutide Versus Placebo and Versus Liraglutide, All as Monotherapy in Japanese Subjects With Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Assets

Liraglutide / Semaglutide

Listed sites

16

Recruiting sites

-

Actual enrollment

243

Study population

Type 2 diabetes

Eligibility highlights

•HbA1c 6.5-9.5%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03018028
Org study IDNN9924-4281
Secondary IDJapicCTI-173489JAPIC
Secondary IDU1111-1181-4048WHO

Timeline

Milestones

Study start2017-01-10actual
Study first posted2017-01-11estimated
Primary completion2018-01-09actual
Study completion2018-08-15actual
Results first posted2019-12-30actual
Last update posted2021-01-15actual

Assets

Investigational agents

LiraglutideSemaglutide

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age20 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
•Japanese male or female, age above or equal to 20 years at the time of signing informed consent
•Diagnosed with type 2 diabetes mellitus for at least 30 days prior to day of screening
•HbA1c 6.5%-9.5% (48-80 mmol/mol) (both inclusive) for subjects treated with oral antidiabetic drug as monotherapy and 7.0%-10.0% (53-86 mmol/mol) (both inclusive) for subjects treated with diet and exercise therapy alone
•Treatment for at least 30 days prior to day of screening with;- stable daily dose of oral anti-diabetic drug as monotherapy (allowed oral anti-diabetic drugs are: metformin, sulphonylurea, glinide, α-glucosidase inhibitor, dipeptidyl peptidase-4 inhibitor and sodium-glucose cotransporter-2 inhibitor) at a half-maximum approved dose or below according to Japanese labelling in addition to diet and exercise therapy. or - diet and exercise therapy alone

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives
•Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
•Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC)
•History of pancreatitis (acute or chronic)
•History of major surgical procedures involving the stomach and potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
•Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation
•Subject presently classified as being in New York Heart Association (NYHA) Class IV
•Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
•Subjects with alanine aminotransferase (ALT) above 2.5 x upper normal limit (UNL)
•Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) below 30 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
•Treatment with once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA), once weekly dipeptidyl peptidase-4 (DPP-4) inhibitor or thiazolidinedione in a period of 90 days before the day of screening
•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of below or equal to 14 days
•Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation
•History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)
•Initiation of anti-diabetic medication between the day of screening and the day of randomisation

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

Glycemic / diabetes
35
Safety / tolerability / PK
27
Cardiometabolic biomarkers
15
Weight & body composition
12
Patient-reported / QoL
10
Other clinical outcomes
1

Weight & body composition

12 endpoints
Secondary/registry result

Change in Body Weight (kg)

Time frame:Week 0, week 26, week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupMean · Kilogram (kg)95% CI
Oral Semaglutide 3 mgWeek 26-0.4-
Week 520.0-
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 260.1-
Week 520.5-
PlaceboWeek 26-1.1-
Week 52-1.0-
Secondary/registry result

Change in Body Weight (%)

Time frame:Week 0, week 26 and week 52

Body weight, % change

percent change from baseline, improvement

Posted result

GroupMean · Percentage change95% 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 260.08-
Week 520.68-
PlaceboWeek 26-1.58-
Week 52-1.42-
Secondary/registry result

Change in Body Mass Index

Time frame:Week 0, week 26 and week 52

BMI, change

change from baseline, improvement

Posted result

GroupMean · Kilogram per square meter (kg/m^2)95% CI
Oral Semaglutide 3 mgWeek 26-0.1-
Week 520.0-
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 260.0-
Week 520.2-
PlaceboWeek 26-0.4-
Week 52-0.4-
Secondary/registry result

Change in Waist Circumference

Time frame:Week 0, week 26 and week 52

Waist circumference, change

change from baseline, improvement

Posted result

GroupMean · Centimeters (cm)95% CI
Oral Semaglutide 3 mgWeek 260.5-
Week 520.2-
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 260.0-
Week 521.0-
PlaceboWeek 26-0.5-
Week 52-0.9-
Secondary/registry result

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

GroupParticipants95% CI
Oral Semaglutide 3 mgWeek 261-
Week 2642-
Week 521-
Week 5237-
Oral Semaglutide 7 mgWeek 265-
Week 2640-
Week 525-
Week 5238-
Oral Semaglutide 14 mgWeek 2616-
Week 2628-
Week 5217-
Week 5224-
Liraglutide 0.9 mgWeek 260-
Week 2645-
Week 522-
Week 5239-
PlaceboWeek 263-
Week 2638-
Week 522-
Week 5232-
Secondary/registry result

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

GroupParticipants95% CI
Oral Semaglutide 3 mgWeek 260-
Week 2643-
Week 520-
Week 5238-
Oral Semaglutide 7 mgWeek 260-
Week 2645-
Week 521-
Week 5242-
Oral Semaglutide 14 mgWeek 263-
Week 2641-
Week 526-
Week 5235-
Liraglutide 0.9 mgWeek 260-
Week 2645-
Week 520-
Week 5241-
PlaceboWeek 260-
Week 2641-
Week 520-
Week 5234-
Secondary/protocol endpoint

Change in Body Weight (kg)

Time frame:Week 0, week 26, week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight (%)

Time frame:Week 0, week 26 and week 52

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index

Time frame:Week 0, week 26 and week 52

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Week 0, week 26 and week 52

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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 endpoints
Primary/registry result

Change in HbA1c (Week 26)

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupMean · Percentage point of HbA1c95% 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-
Treatment difference-1.195% CI-1.4 - -0.8p<0.0001Mixed model for repeated measurements
Treatment difference-1.595% CI-1.7 - -1.2p<0.0001Mixed model for repeated measurements
Treatment difference-1.795% CI-2.0 - -1.4p<0.0001Mixed model for repeated measurements
Treatment difference0.395% CI-0.0 - 0.6p0.0799Mixed model for repeated measurements
Treatment difference-0.195% CI-0.4 - 0.2p0.3942Mixed model for repeated measurements
Treatment difference-0.395% CI-0.6 - -0.0p0.0272Mixed model for repeated measurement
Treatment difference-0.895% CI-1.1 - -0.5p<0.0001Pattern Mixture model
Treatment difference-1.295% CI-1.5 - -0.9p<0.0001Pattern Mixture model
Treatment difference-1.495% CI-1.7 - -1.1p<0.0001Pattern Mixture model
Treatment difference0.295% CI-0.1 - 0.5p0.1958Pattern Mixture model
Treatment difference-0.295% CI-0.5 - 0.1p0.1868Pattern Mixture model
Treatment difference-0.495% CI-0.7 - -0.1p0.0077Pattern Mixture model
Primary/protocol endpoint

Change in HbA1c (Week 26)

Time frame:Week 0, week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change in HbA1c (Week 52)

Time frame:Week 0, week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupMean · % HbA1c95% 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-
Placebo0.1-
Secondary/registry result

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

GroupMean · 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 520.33-
Secondary/registry result

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

GroupMean · mmol/L95% 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-
Secondary/registry result

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

GroupMean · mmol/L95% 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-
Secondary/registry result

Change in Fasting Insulin (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

ratio, improvement

Posted result

GroupGeometric mean · Ratio of insulin95% CI
Oral Semaglutide 3 mgWeek 261.19-
Week 521.07-
Oral Semaglutide 7 mgWeek 261.27-
Week 521.16-
Oral Semaglutide 14 mgWeek 261.10-
Week 521.04-
Liraglutide 0.9 mgWeek 261.14-
Week 521.06-
PlaceboWeek 260.92-
Week 520.93-
Secondary/registry result

Change in Fasting C-peptide (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

ratio, improvement

Posted result

GroupGeometric mean · Ratio of C-peptide95% CI
Oral Semaglutide 3 mgWeek 261.15-
Week 521.12-
Oral Semaglutide 7 mgWeek 261.24-
Week 521.19-
Oral Semaglutide 14 mgWeek 261.17-
Week 521.10-
Liraglutide 0.9 mgWeek 261.18-
Week 521.11-
PlaceboWeek 260.98-
Week 520.99-
Secondary/registry result

Change in Fasting Pro-insulin (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

ratio, improvement

Posted result

GroupGeometric mean · Ratio of pro-insulin95% CI
Oral Semaglutide 3 mgWeek 260.69-
Week 520.83-
Oral Semaglutide 7 mgWeek 260.68-
Week 520.78-
Oral Semaglutide 14 mgWeek 260.51-
Week 520.56-
Liraglutide 0.9 mgWeek 260.61-
Week 520.72-
PlaceboWeek 260.85-
Week 521.04-
Secondary/registry result

Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

ratio, improvement

Posted result

GroupGeometric mean · Ratio of pro-insulin/insulin ratio95% CI
Oral Semaglutide 3 mgWeek 260.59-
Week 520.78-
Oral Semaglutide 7 mgWeek 260.54-
Week 520.67-
Oral Semaglutide 14 mgWeek 260.49-
Week 520.56-
Liraglutide 0.9 mgWeek 260.55-
Week 520.69-
PlaceboWeek 260.92-
Week 521.11-
Secondary/registry result

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

GroupGeometric mean · Ratio of insulin resistance95% CI
Oral Semaglutide 3 mgWeek 260.98-
Week 520.93-
Oral Semaglutide 7 mgWeek 261.02-
Week 520.95-
Oral Semaglutide 14 mgWeek 260.83-
Week 520.78-
Liraglutide 0.9 mgWeek 260.86-
Week 520.82-
PlaceboWeek 260.88-
Week 520.97-
Secondary/registry result

Change in Beta-cell Function (HOMA-B) (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

ratio, improvement

Posted result

GroupGeometric mean · Ratio of beta-cell function95% CI
Oral Semaglutide 3 mgWeek 261.71-
Week 521.36-
Oral Semaglutide 7 mgWeek 261.93-
Week 521.75-
Oral Semaglutide 14 mgWeek 261.95-
Week 521.86-
Liraglutide 0.9 mgWeek 261.89-
Week 521.69-
PlaceboWeek 261.00-
Week 520.89-
Secondary/registry result

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

GroupParticipants95% CI
Oral Semaglutide 3 mgWeek 2624-
Week 2619-
Week 5219-
Week 5219-
Oral Semaglutide 7 mgWeek 2633-
Week 2612-
Week 5229-
Week 5214-
Oral Semaglutide 14 mgWeek 2635-
Week 269-
Week 5233-
Week 528-
Liraglutide 0.9 mgWeek 2624-
Week 2621-
Week 5220-
Week 5221-
PlaceboWeek 266-
Week 2635-
Week 524-
Week 5230-
Secondary/registry result

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

GroupParticipants95% CI
Oral Semaglutide 3 mgWeek 2613-
Week 2630-
Week 5211-
Week 5227-
Oral Semaglutide 7 mgWeek 2624-
Week 2621-
Week 5220-
Week 5223-
Oral Semaglutide 14 mgWeek 2628-
Week 2616-
Week 5224-
Week 5217-
Liraglutide 0.9 mgWeek 2616-
Week 2629-
Week 5211-
Week 5230-
PlaceboWeek 262-
Week 2639-
Week 521-
Week 5233-
Secondary/registry result

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

GroupParticipants95% CI
Oral Semaglutide 3 mgWeek 2615-
Week 2628-
Week 5212-
Week 5226-
Oral Semaglutide 7 mgWeek 2626-
Week 2619-
Week 5224-
Week 5219-
Oral Semaglutide 14 mgWeek 2630-
Week 2614-
Week 5228-
Week 5213-
Liraglutide 0.9 mgWeek 2615-
Week 2630-
Week 529-
Week 5232-
PlaceboWeek 264-
Week 2637-
Week 524-
Week 5230-
Secondary/registry result

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

GroupParticipants95% CI
Oral Semaglutide 3 mgWeek 267-
Week 2636-
Week 528-
Week 5230-
Oral Semaglutide 7 mgWeek 2611-
Week 2634-
Week 527-
Week 5236-
Oral Semaglutide 14 mgWeek 2621-
Week 2623-
Week 5220-
Week 5221-
Liraglutide 0.9 mgWeek 265-
Week 2640-
Week 522-
Week 5239-
PlaceboWeek 263-
Week 2638-
Week 521-
Week 5233-
Secondary/registry result

Time to Additional Anti-diabetic Medication

Time frame:Weeks 0 - 52

threshold achievement, event

Posted result

GroupParticipants95% CI
Oral Semaglutide 3 mgUp to Week 263-
Up to Week 528-
Oral Semaglutide 7 mgUp to Week 263-
Up to Week 526-
Oral Semaglutide 14 mgUp to Week 261-
Up to Week 524-
Liraglutide 0.9 mgUp to Week 260-
Up to Week 524-
PlaceboUp to Week 267-
Up to Week 5215-
Hazard ratio (hr)0.6395% CI0.29 - 1.40p0.2579Regression, Cox
Hazard ratio (hr)0.2595% CI0.10 - 0.66p0.0052Regression, Cox
Hazard ratio (hr)0.3195% CI0.11 - 0.87p0.0259Regression, Cox
Hazard ratio (hr)2.7095% CI0.93 - 7.80p0.0674Regression, Cox
Hazard ratio (hr)1.0795% CI0.32 - 3.54p0.9087Regression, Cox
Hazard ratio (hr)1.3395% CI0.38 - 4.62p0.6498Regression, Cox
Secondary/registry result

Time to Rescue Medication

Time frame:Weeks 0 - 52

time to event, event

Posted result

GroupParticipants95% CI
Oral Semaglutide 3 mgUp to Week 262-
Up to Week 527-
Oral Semaglutide 7 mgUp to Week 262-
Up to Week 525-
Oral Semaglutide 14 mgUp to Week 261-
Up to Week 524-
Liraglutide 0.9 mgUp to Week 260-
Up to Week 523-
PlaceboUp to Week 267-
Up to Week 5215-
Hazard ratio (hr)0.3495% CI0.14 - 0.86p0.0219Regression, Cox
Hazard ratio (hr)0.1595% CI0.05 - 0.44p0.0005Regression, Cox
Hazard ratio (hr)0.2395% CI0.07 - 0.70p0.0098Regression, Cox
Hazard ratio (hr)2.9595% CI0.76 - 11.46p0.1193Regression, Cox
Hazard ratio (hr)1.3195% CI0.31 - 5.56p0.7147Regression, Cox
Hazard ratio (hr)1.9795% CI0.44 - 8.85p0.3765Regression, Cox
Secondary/protocol endpoint

Change in HbA1c (Week 52)

Time frame:Week 0, week 52

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose

Time frame:Week 0, week 26, week 52

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Change in Fasting Insulin (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

ratio, improvement

Secondary/protocol endpoint

Change in Fasting C-peptide (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

ratio, improvement

Secondary/protocol endpoint

Change in Fasting Glucagon (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

ratio, improvement

Secondary/protocol endpoint

Change in Fasting Pro-insulin (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

ratio, improvement

Secondary/protocol endpoint

Change in Fasting Pro-insulin/Insulin Ratio (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

ratio, improvement

Secondary/protocol endpoint

Change in Insulin Resistance (HOMA-IR) (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

HOMA-IR (insulin sensitivity)

ratio, improvement

Secondary/protocol endpoint

Change in Beta-cell Function (HOMA-B) (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

ratio, improvement

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Time to Additional Anti-diabetic Medication

Time frame:Weeks 0 - 52

time to event, event

Secondary/protocol endpoint

Time to Rescue Medication

Time frame:Weeks 0 - 52

time to event, event

Cardiometabolic biomarkers

15 endpoints
Secondary/registry result

Change 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

GroupGeometric mean · Ratio of total cholesterol95% CI
Oral Semaglutide 3 mgWeek 260.92-
Week 520.99-
Oral Semaglutide 7 mgWeek 260.93-
Week 520.95-
Oral Semaglutide 14 mgWeek 260.89-
Week 520.93-
Liraglutide 0.9 mgWeek 260.94-
Week 520.95-
PlaceboWeek 261.00-
Week 521.01-
Secondary/registry result

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

GroupGeometric mean · Ratio of HDL cholesterol95% CI
Oral Semaglutide 3 mgWeek 260.97-
Week 521.05-
Oral Semaglutide 7 mgWeek 260.98-
Week 521.01-
Oral Semaglutide 14 mgWeek 260.96-
Week 520.99-
Liraglutide 0.9 mgWeek 260.99-
Week 520.98-
PlaceboWeek 261.03-
Week 521.04-
Secondary/registry result

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

GroupGeometric mean · Ratio of LDL cholesterol95% CI
Oral Semaglutide 3 mgWeek 260.87-
Week 520.99-
Oral Semaglutide 7 mgWeek 260.89-
Week 520.96-
Oral Semaglutide 14 mgWeek 260.85-
Week 520.91-
Liraglutide 0.9 mgWeek 260.91-
Week 520.95-
PlaceboWeek 261.03-
Week 521.06-
Secondary/registry result

Change in VLDL Cholesterol (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

VLDL, change

ratio, improvement

Posted result

GroupGeometric mean · Ratio of VLDL cholesterol95% CI
Oral Semaglutide 3 mgWeek 261.02-
Week 520.86-
Oral Semaglutide 7 mgWeek 260.94-
Week 520.84-
Oral Semaglutide 14 mgWeek 260.93-
Week 520.86-
Liraglutide 0.9 mgWeek 260.99-
Week 520.87-
PlaceboWeek 260.87-
Week 520.81-
Secondary/registry result

Change in Triglycerides (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

GroupGeometric mean · Ratio of triglycerides95% CI
Oral Semaglutide 3 mgWeek 261.03-
Week 520.86-
Oral Semaglutide 7 mgWeek 260.94-
Week 520.84-
Oral Semaglutide 14 mgWeek 260.93-
Week 520.86-
Liraglutide 0.9 mgWeek 260.99-
Week 520.87-
PlaceboWeek 260.87-
Week 520.82-
Secondary/registry result

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

GroupGeometric mean · Ratio of glucagon95% CI
Oral Semaglutide 3 mgWeek 260.95-
Week 520.97-
Oral Semaglutide 7 mgWeek 260.89-
Week 520.95-
Oral Semaglutide 14 mgWeek 260.85-
Week 520.92-
Liraglutide 0.9 mgWeek 260.91-
Week 520.93-
PlaceboWeek 260.95-
Week 520.96-
Secondary/registry result

Change in Pulse Rate

Time frame:Week 0, week 26, week 52

Heart rate, change

change from baseline, improvement

Posted result

GroupMean · Beats per minute (beats/min)95% CI
Oral Semaglutide 3 mgWeek 261-
Week 521-
Oral Semaglutide 7 mgWeek 262-
Week 523-
Oral Semaglutide 14 mgWeek 262-
Week 524-
Liraglutide 0.9 mgWeek 262-
Week 522-
PlaceboWeek 260-
Week 520-
Secondary/registry result

Change in Blood Pressure

Time frame:Week 0, week 26, week 52

change from baseline, improvement

Posted result

GroupMean · 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: dBP1-
Week 52: dBP-0-
Liraglutide 0.9 mgWeek 26: sBP-1-
Week 52: sBP1-
Week 26: dBP-1-
Week 52: dBP-0-
PlaceboWeek 26: sBP-4-
Week 52: sBP-3-
Week 26: dBP-3-
Week 52: dBP-2-
Secondary/protocol endpoint

Change in Total Cholesterol (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in HDL Cholesterol (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in LDL Cholesterol (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in VLDL Cholesterol (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Triglycerides (Ratio to Baseline)

Time frame:Week 0, week 26 and week 52

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Pulse Rate

Time frame:Week 0, week 26, week 52

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Blood Pressure

Time frame:Week 0, week 26, week 52

change from baseline, improvement

Patient-reported / QoL

10 endpoints
Secondary/registry result

Change in SF-36: Sub-domains

Time frame:Week 0, week 26, week 52

change from baseline, improvement

Posted result

GroupMean · Score on a scale95% 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 Functioning0.30-
Week 26: Role-Physical0.00-
Week 52: Role-Physical0.15-
Week 26: Bodily Pain-0.89-
Week 52: Bodily Pain-0.16-
Week 26: General Health0.52-
Week 52: General Health-1.24-
Week 26: Vitality-0.48-
Week 52: Vitality-0.82-
Week 26: Social Functioning0.77-
Week 52: Social Functioning-0.58-
Week 26: Role-Emotional-0.00-
Week 52: Role-Emotional0.18-
Week 26: Mental Health0.77-
Week 52: Mental Health-0.52-
Oral Semaglutide 14 mgWeek 26: Physical Functioning0.04-
Week 52: Physical Functioning-0.00-
Week 26: Role-Physical0.05-
Week 52: Role-Physical-0.86-
Week 26: Bodily Pain1.18-
Week 52: Bodily Pain0.03-
Week 26: General Health0.41-
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 Functioning0.00-
Week 26: Role-Emotional0.35-
Week 52: Role-Emotional-0.47-
Week 26: Mental Health-2.36-
Week 52: Mental Health-1.69-
Liraglutide 0.9 mgWeek 26: Physical Functioning0.09-
Week 52: Physical Functioning-0.09-
Week 26: Role-Physical0.10-
Week 52: Role-Physical-0.59-
Week 26: Bodily Pain0.48-
Week 52: Bodily Pain0.98-
Week 26: General Health-0.00-
Week 52: General Health0.62-
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 Health1.71-
Week 52: Mental Health0.72-
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-
Secondary/registry result

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

GroupMean · Score on a scale95% 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 260.93-
Week 520.02-
Liraglutide 0.9 mgWeek 26-0.14-
Week 520.10-
PlaceboWeek 260.20-
Week 52-0.10-
Secondary/registry result

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

GroupMean · Score on a scale95% CI
Oral Semaglutide 3 mgWeek 26-1.81-
Week 52-1.56-
Oral Semaglutide 7 mgWeek 260.56-
Week 52-0.58-
Oral Semaglutide 14 mgWeek 26-1.61-
Week 52-1.16-
Liraglutide 0.9 mgWeek 260.49-
Week 520.10-
PlaceboWeek 26-2.18-
Week 52-1.94-
Secondary/registry result

Change From Baseline in DTR-QOL: Total Score

Time frame:Week 0, week 26, week 52

change from baseline, improvement

Posted result

GroupMean · Score on a scale95% CI
Oral Semaglutide 3 mgWeek 266.67-
Week 526.97-
Oral Semaglutide 7 mgWeek 267.98-
Week 525.52-
Oral Semaglutide 14 mgWeek 2611.22-
Week 528.02-
Liraglutide 0.9 mgWeek 269.77-
Week 527.12-
PlaceboWeek 264.18-
Week 520.57-
Secondary/registry result

Change From Baseline in DTR-QOL: Sub-domains

Time frame:Week 0, week 26, week 52

change from baseline, improvement

Posted result

GroupMean · Score on a scale95% CI
Oral Semaglutide 3 mgW26: Burden on social and daily activities5.75-
W52: Burden on social and daily activities9.31-
W26: Anxiety and dissatisfaction with treatment6.49-
W52: Anxiety and dissatisfaction with treatment4.93-
Week 26: Hypoglycemia8.33-
Week 52: Hypoglycemia5.81-
Week 26: Satisfaction with treatment8.33-
Week 52: Satisfaction with treatment4.61-
Oral Semaglutide 7 mgW26: Burden on social and daily activities5.87-
W52: Burden on social and daily activities5.49-
W26: Anxiety and dissatisfaction with treatment10.46-
W52: Anxiety and dissatisfaction with treatment5.04-
Week 26: Hypoglycemia3.15-
Week 52: Hypoglycemia1.26-
Week 26: Satisfaction with treatment14.72-
Week 52: Satisfaction with treatment10.85-
Oral Semaglutide 14 mgW26: Burden on social and daily activities7.90-
W52: Burden on social and daily activities3.94-
W26: Anxiety and dissatisfaction with treatment14.68-
W52: Anxiety and dissatisfaction with treatment10.52-
Week 26: Hypoglycemia9.19-
Week 52: Hypoglycemia8.13-
Week 26: Satisfaction with treatment17.14-
Week 52: Satisfaction with treatment16.16-
Liraglutide 0.9 mgW26: Burden on social and daily activities10.11-
W52: Burden on social and daily activities7.60-
W26: Anxiety and dissatisfaction with treatment13.52-
W52: Anxiety and dissatisfaction with treatment7.01-
Week 26: Hypoglycemia3.80-
Week 52: Hypoglycemia4.47-
Week 26: Satisfaction with treatment7.13-
Week 52: Satisfaction with treatment8.43-
PlaceboW26: Burden on social and daily activities6.91-
W52: Burden on social and daily activities2.90-
W26: Anxiety and dissatisfaction with treatment1.83-
W52: Anxiety and dissatisfaction with treatment-2.94-
Week 26: Hypoglycemia7.42-
Week 52: Hypoglycemia6.00-
Week 26: Satisfaction with treatment-3.25-
Week 52: Satisfaction with treatment-5.39-
Secondary/protocol endpoint

Change in SF-36: Sub-domains

Time frame:Week 0, week 26, week 52

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: Physical Component Summary (PCS)

Time frame:Week 0, week 26, week 52

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36: Mental Component Summary (MCS)

Time frame:Week 0, week 26, week 52

SF-36 mental

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in DTR-QOL: Total Score

Time frame:Week 0, week 26, week 52

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in DTR-QOL: Sub-domains

Time frame:Week 0, week 26, week 52

change from baseline, improvement

Safety / tolerability / PK

27 endpoints
Secondary/registry result

Number of Treatment-emergent Adverse Events (TEAEs)

Time frame:Weeks 0 - 57

Treatment-emergent AEs (any)

event count, event

Posted result

GroupNumber · Adverse events95% CI
Oral Semaglutide 3 mg119-
Oral Semaglutide 7 mg111-
Oral Semaglutide 14 mg96-
Liraglutide 0.9 mg116-
Placebo106-
Secondary/registry result

Change in Amylase (Ratio to Baseine)

Time frame:Week 0, week 26, week 52

ratio, descriptive

Posted result

GroupGeometric mean · Ratio of amylase95% CI
Oral Semaglutide 3 mgWeek 261.03-
Week 521.06-
Oral Semaglutide 7 mgWeek 261.10-
Week 521.10-
Oral Semaglutide 14 mgWeek 261.16-
Week 521.12-
Liraglutide 0.9 mgWeek 261.07-
Week 521.06-
PlaceboWeek 261.02-
Week 521.02-
Secondary/registry result

Change in Lipase (Ratio to Baseine)

Time frame:Week 0, week 26, week 52

ratio, descriptive

Posted result

GroupGeometric mean · Ratio of lipase95% CI
Oral Semaglutide 3 mgWeek 261.25-
Week 521.29-
Oral Semaglutide 7 mgWeek 261.35-
Week 521.41-
Oral Semaglutide 14 mgWeek 261.61-
Week 521.47-
Liraglutide 0.9 mgWeek 261.47-
Week 521.60-
PlaceboWeek 261.04-
Week 521.03-
Secondary/registry result

Change in ECG Evaluation

Time frame:Week 0, week 26, week 52

categorical status, descriptive

Posted result

GroupParticipants95% 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-
Secondary/registry result

Change in Physical Examination

Time frame:Baseline (Week -8), week 26, week 52

categorical status, descriptive

Posted result

GroupParticipants95% CI
Oral Semaglutide 3 mgWeek -8: Cardiovascular- Normal49-
Week -8: Cardiovascular- Abnormal NCS0-
Week -8: Cardiovascular- Abnormal CS0-
Week 26: Cardiovascular- Normal46-
Week 26: Cardiovascular- Abnormal NCS0-
Week 26: Cardiovascular- Abnormal CS0-
Week 52: Cardiovascular- Normal46-
Week 52: Cardiovascular- Abnormal NCS0-
Week 52: Cardiovascular- Abnormal CS0-
Week -8: Nervous system- Normal48-
Week -8: Nervous system- Abnormal NCS1-
Week -8: Nervous system- Abnormal CS0-
Week 26: Nervous system- Normal45-
Week 26: Nervous system- Abnormal NCS1-
Week 26: Nervous system- Abnormal CS0-
Week 52: Nervous system- Normal45-
Week 52: Nervous system- Abnormal NCS1-
Week 52: Nervous system- Abnormal CS0-
Week -8: Gastrointestinal sys- Normal46-
Week -8: Gastrointestinal sys- Abnormal NCS2-
Week -8: Gastrointestinal sys- Abnormal CS1-
Week 26: Gastrointestinal sys - Normal44-
Week 26: Gastrointestinal sys- Abnormal NCS1-
Week 26: Gastrointestinal sys- Abnormal CS1-
Week 52: Gastrointestinal sys- Normal43-
Week 52: Gastrointestinal sys- Abnormal NCS2-
Week 52: Gastrointestinal sys- Abnormal CS1-
Week -8: General appearance- Normal47-
Week -8: General appearance- Abnormal NCS2-
Week -8: General appearance- Abnormal CS0-
Week 26: General appearance- Normal44-
Week 26: General appearance- Abnormal NCS2-
Week 26: General appearance- Abnormal CS0-
Week 52: General appearance- Normal43-
Week 52: General appearance- Abnormal NCS2-
Week 52: General appearance- Abnormal CS1-
Week -8: Head and neck- Normal44-
Week -8: Head and neck- Abnormal NCS5-
Week -8: Head and neck- Abnormal CS0-
Week 26: Head and neck- Normal43-
Week 26: Head and neck- Abnormal NCS3-
Week 26: Head and neck- Abnormal CS0-
Week 52: Head and neck- Normal42-
Week 52: Head and neck- Abnormal NCS4-
Week 52: Head and neck- Abnormal CS0-
Week -8: Lymph node- Normal49-
Week -8: Lymph node- Abnormal NCS0-
Week -8: Lymph node- Abnormal CS0-
Week 26: Lymph node- Normal46-
Week 26: Lymph node- Abnormal NCS0-
Week 26: Lymph node- Abnormal CS0-
Week 52: Lymph node- Normal46-
Week 52: Lymph node- Abnormal NCS0-
Week 52: Lymph node- Abnormal CS0-
Week -8: Musculoskeletal- Normal47-
Week -8: Musculoskeletal- Abnormal NCS2-
Week -8: Musculoskeletal- Abnormal CS0-
Week 26: Musculoskeletal- Normal42-
Week 26: Musculoskeletal- Abnormal NCS4-
Week 26: Musculoskeletal- Abnormal CS0-
Week 52: Musculoskeletal- Normal41-
Week 52: Musculoskeletal- Abnormal NCS5-
Week 52: Musculoskeletal- Abnormal CS0-
Week -8: Respiratory sys- Normal49-
Week -8: Respiratory sys- Abnormal NCS0-
Week -8: Respiratory sys- Abnormal CS0-
Week 26: Respiratory sys- Normal46-
Week 26: Respiratory sys- Abnormal NCS0-
Week 26: Respiratory sys- Abnormal CS0-
Week 52: Respiratory sys- Normal46-
Week 52: Respiratory sys- Abnormal NCS0-
Week 52: Respiratory sys- Abnormal CS0-
Week -8: Skin- Normal46-
Week -8: Skin- Abnormal NCS2-
Week -8: Skin- Abnormal CS1-
Week 26: Skin- Normal44-
Week 26: Skin- Abnormal NCS1-
Week 26: Skin- Abnormal CS1-
Week 52: Skin- Normal44-
Week 52: Skin- Abnormal NCS1-
Week 52: Skin- Abnormal CS1-
Week -8: Thyroid - Normal48-
Week -8: Thyroid- Abnormal NCS1-
Week -8: Thyroid- Abnormal CS0-
Week 26: Thyroid- Normal45-
Week 26: Thyroid- Abnormal NCS1-
Week 26: Thyroid- Abnormal CS0-
Week 52: Thyroid- Normal45-
Week 52: Thyroid- Abnormal NCS1-
Week 52: Thyroid- Abnormal CS0-
Oral Semaglutide 7 mgWeek -8: Cardiovascular- Normal49-
Week -8: Cardiovascular- Abnormal NCS0-
Week -8: Cardiovascular- Abnormal CS0-
Week 26: Cardiovascular- Normal49-
Week 26: Cardiovascular- Abnormal NCS0-
Week 26: Cardiovascular- Abnormal CS0-
Week 52: Cardiovascular- Normal49-
Week 52: Cardiovascular- Abnormal NCS0-
Week 52: Cardiovascular- Abnormal CS0-
Week -8: Nervous system- Normal48-
Week -8: Nervous system- Abnormal NCS0-
Week -8: Nervous system- Abnormal CS1-
Week 26: Nervous system- Normal48-
Week 26: Nervous system- Abnormal NCS0-
Week 26: Nervous system- Abnormal CS1-
Week 52: Nervous system- Normal48-
Week 52: Nervous system- Abnormal NCS0-
Week 52: Nervous system- Abnormal CS1-
Week -8: Gastrointestinal sys- Normal47-
Week -8: Gastrointestinal sys- Abnormal NCS1-
Week -8: Gastrointestinal sys- Abnormal CS1-
Week 26: Gastrointestinal sys - Normal47-
Week 26: Gastrointestinal sys- Abnormal NCS1-
Week 26: Gastrointestinal sys- Abnormal CS1-
Week 52: Gastrointestinal sys- Normal45-
Week 52: Gastrointestinal sys- Abnormal NCS3-
Week 52: Gastrointestinal sys- Abnormal CS1-
Week -8: General appearance- Normal47-
Week -8: General appearance- Abnormal NCS2-
Week -8: General appearance- Abnormal CS0-
Week 26: General appearance- Normal47-
Week 26: General appearance- Abnormal NCS2-
Week 26: General appearance- Abnormal CS0-
Week 52: General appearance- Normal48-
Week 52: General appearance- Abnormal NCS1-
Week 52: General appearance- Abnormal CS0-
Week -8: Head and neck- Normal45-
Week -8: Head and neck- Abnormal NCS1-
Week -8: Head and neck- Abnormal CS3-
Week 26: Head and neck- Normal47-
Week 26: Head and neck- Abnormal NCS0-
Week 26: Head and neck- Abnormal CS2-
Week 52: Head and neck- Normal47-
Week 52: Head and neck- Abnormal NCS0-
Week 52: Head and neck- Abnormal CS2-
Week -8: Lymph node- Normal49-
Week -8: Lymph node- Abnormal NCS0-
Week -8: Lymph node- Abnormal CS0-
Week 26: Lymph node- Normal49-
Week 26: Lymph node- Abnormal NCS0-
Week 26: Lymph node- Abnormal CS0-
Week 52: Lymph node- Normal49-
Week 52: Lymph node- Abnormal NCS0-
Week 52: Lymph node- Abnormal CS0-
Week -8: Musculoskeletal- Normal44-
Week -8: Musculoskeletal- Abnormal NCS3-
Week -8: Musculoskeletal- Abnormal CS2-
Week 26: Musculoskeletal- Normal45-
Week 26: Musculoskeletal- Abnormal NCS2-
Week 26: Musculoskeletal- Abnormal CS2-
Week 52: Musculoskeletal- Normal45-
Week 52: Musculoskeletal- Abnormal NCS2-
Week 52: Musculoskeletal- Abnormal CS2-
Week -8: Respiratory sys- Normal49-
Week -8: Respiratory sys- Abnormal NCS0-
Week -8: Respiratory sys- Abnormal CS0-
Week 26: Respiratory sys- Normal48-
Week 26: Respiratory sys- Abnormal NCS1-
Week 26: Respiratory sys- Abnormal CS0-
Week 52: Respiratory sys- Normal49-
Week 52: Respiratory sys- Abnormal NCS0-
Week 52: Respiratory sys- Abnormal CS0-
Week -8: Skin- Normal48-
Week -8: Skin- Abnormal NCS1-
Week -8: Skin- Abnormal CS0-
Week 26: Skin- Normal47-
Week 26: Skin- Abnormal NCS1-
Week 26: Skin- Abnormal CS1-
Week 52: Skin- Normal47-
Week 52: Skin- Abnormal NCS1-
Week 52: Skin- Abnormal CS1-
Week -8: Thyroid - Normal48-
Week -8: Thyroid- Abnormal NCS0-
Week -8: Thyroid- Abnormal CS1-
Week 26: Thyroid- Normal48-
Week 26: Thyroid- Abnormal NCS0-
Week 26: Thyroid- Abnormal CS1-
Week 52: Thyroid- Normal48-
Week 52: Thyroid- Abnormal NCS0-
Week 52: Thyroid- Abnormal CS1-
Oral Semaglutide 14 mgWeek -8: Cardiovascular- Normal48-
Week -8: Cardiovascular- Abnormal NCS0-
Week -8: Cardiovascular- Abnormal CS0-
Week 26: Cardiovascular- Normal47-
Week 26: Cardiovascular- Abnormal NCS0-
Week 26: Cardiovascular- Abnormal CS0-
Week 52: Cardiovascular- Normal47-
Week 52: Cardiovascular- Abnormal NCS0-
Week 52: Cardiovascular- Abnormal CS0-
Week -8: Nervous system- Normal48-
Week -8: Nervous system- Abnormal NCS0-
Week -8: Nervous system- Abnormal CS0-
Week 26: Nervous system- Normal47-
Week 26: Nervous system- Abnormal NCS0-
Week 26: Nervous system- Abnormal CS0-
Week 52: Nervous system- Normal47-
Week 52: Nervous system- Abnormal NCS0-
Week 52: Nervous system- Abnormal CS0-
Week -8: Gastrointestinal sys- Normal47-
Week -8: Gastrointestinal sys- Abnormal NCS0-
Week -8: Gastrointestinal sys- Abnormal CS1-
Week 26: Gastrointestinal sys - Normal45-
Week 26: Gastrointestinal sys- Abnormal NCS1-
Week 26: Gastrointestinal sys- Abnormal CS1-
Week 52: Gastrointestinal sys- Normal45-
Week 52: Gastrointestinal sys- Abnormal NCS1-
Week 52: Gastrointestinal sys- Abnormal CS1-
Week -8: General appearance- Normal47-
Week -8: General appearance- Abnormal NCS1-
Week -8: General appearance- Abnormal CS0-
Week 26: General appearance- Normal45-
Week 26: General appearance- Abnormal NCS2-
Week 26: General appearance- Abnormal CS0-
Week 52: General appearance- Normal46-
Week 52: General appearance- Abnormal NCS1-
Week 52: General appearance- Abnormal CS0-
Week -8: Head and neck- Normal44-
Week -8: Head and neck- Abnormal NCS1-
Week -8: Head and neck- Abnormal CS3-
Week 26: Head and neck- Normal43-
Week 26: Head and neck- Abnormal NCS1-
Week 26: Head and neck- Abnormal CS3-
Week 52: Head and neck- Normal43-
Week 52: Head and neck- Abnormal NCS2-
Week 52: Head and neck- Abnormal CS2-
Week -8: Lymph node- Normal48-
Week -8: Lymph node- Abnormal NCS0-
Week -8: Lymph node- Abnormal CS0-
Week 26: Lymph node- Normal47-
Week 26: Lymph node- Abnormal NCS0-
Week 26: Lymph node- Abnormal CS0-
Week 52: Lymph node- Normal47-
Week 52: Lymph node- Abnormal NCS0-
Week 52: Lymph node- Abnormal CS0-
Week -8: Musculoskeletal- Normal47-
Week -8: Musculoskeletal- Abnormal NCS0-
Week -8: Musculoskeletal- Abnormal CS1-
Week 26: Musculoskeletal- Normal46-
Week 26: Musculoskeletal- Abnormal NCS0-
Week 26: Musculoskeletal- Abnormal CS1-
Week 52: Musculoskeletal- Normal46-
Week 52: Musculoskeletal- Abnormal NCS0-
Week 52: Musculoskeletal- Abnormal CS1-
Week -8: Respiratory sys- Normal46-
Week -8: Respiratory sys- Abnormal NCS0-
Week -8: Respiratory sys- Abnormal CS2-
Week 26: Respiratory sys- Normal45-
Week 26: Respiratory sys- Abnormal NCS0-
Week 26: Respiratory sys- Abnormal CS2-
Week 52: Respiratory sys- Normal45-
Week 52: Respiratory sys- Abnormal NCS0-
Week 52: Respiratory sys- Abnormal CS2-
Week -8: Skin- Normal45-
Week -8: Skin- Abnormal NCS0-
Week -8: Skin- Abnormal CS3-
Week 26: Skin- Normal44-
Week 26: Skin- Abnormal NCS0-
Week 26: Skin- Abnormal CS3-
Week 52: Skin- Normal44-
Week 52: Skin- Abnormal NCS0-
Week 52: Skin- Abnormal CS3-
Week -8: Thyroid - Normal48-
Week -8: Thyroid- Abnormal NCS0-
Week -8: Thyroid- Abnormal CS0-
Week 26: Thyroid- Normal47-
Week 26: Thyroid- Abnormal NCS0-
Week 26: Thyroid- Abnormal CS0-
Week 52: Thyroid- Normal47-
Week 52: Thyroid- Abnormal NCS0-
Week 52: Thyroid- Abnormal CS0-
Liraglutide 0.9 mgWeek -8: Cardiovascular- Normal48-
Week -8: Cardiovascular- Abnormal NCS0-
Week -8: Cardiovascular- Abnormal CS0-
Week 26: Cardiovascular- Normal45-
Week 26: Cardiovascular- Abnormal NCS0-
Week 26: Cardiovascular- Abnormal CS0-
Week 52: Cardiovascular- Normal45-
Week 52: Cardiovascular- Abnormal NCS0-
Week 52: Cardiovascular- Abnormal CS0-
Week -8: Nervous system- Normal48-
Week -8: Nervous system- Abnormal NCS0-
Week -8: Nervous system- Abnormal CS0-
Week 26: Nervous system- Normal45-
Week 26: Nervous system- Abnormal NCS0-
Week 26: Nervous system- Abnormal CS0-
Week 52: Nervous system- Normal45-
Week 52: Nervous system- Abnormal NCS0-
Week 52: Nervous system- Abnormal CS0-
Week -8: Gastrointestinal sys- Normal47-
Week -8: Gastrointestinal sys- Abnormal NCS0-
Week -8: Gastrointestinal sys- Abnormal CS1-
Week 26: Gastrointestinal sys - Normal44-
Week 26: Gastrointestinal sys- Abnormal NCS0-
Week 26: Gastrointestinal sys- Abnormal CS1-
Week 52: Gastrointestinal sys- Normal44-
Week 52: Gastrointestinal sys- Abnormal NCS0-
Week 52: Gastrointestinal sys- Abnormal CS1-
Week -8: General appearance- Normal47-
Week -8: General appearance- Abnormal NCS1-
Week -8: General appearance- Abnormal CS0-
Week 26: General appearance- Normal44-
Week 26: General appearance- Abnormal NCS1-
Week 26: General appearance- Abnormal CS0-
Week 52: General appearance- Normal44-
Week 52: General appearance- Abnormal NCS1-
Week 52: General appearance- Abnormal CS0-
Week -8: Head and neck- Normal45-
Week -8: Head and neck- Abnormal NCS3-
Week -8: Head and neck- Abnormal CS0-
Week 26: Head and neck- Normal44-
Week 26: Head and neck- Abnormal NCS1-
Week 26: Head and neck- Abnormal CS0-
Week 52: Head and neck- Normal44-
Week 52: Head and neck- Abnormal NCS1-
Week 52: Head and neck- Abnormal CS0-
Week -8: Lymph node- Normal48-
Week -8: Lymph node- Abnormal NCS0-
Week -8: Lymph node- Abnormal CS0-
Week 26: Lymph node- Normal45-
Week 26: Lymph node- Abnormal NCS0-
Week 26: Lymph node- Abnormal CS0-
Week 52: Lymph node- Normal45-
Week 52: Lymph node- Abnormal NCS0-
Week 52: Lymph node- Abnormal CS0-
Week -8: Musculoskeletal- Normal48-
Week -8: Musculoskeletal- Abnormal NCS0-
Week -8: Musculoskeletal- Abnormal CS0-
Week 26: Musculoskeletal- Normal43-
Week 26: Musculoskeletal- Abnormal NCS1-
Week 26: Musculoskeletal- Abnormal CS1-
Week 52: Musculoskeletal- Normal45-
Week 52: Musculoskeletal- Abnormal NCS0-
Week 52: Musculoskeletal- Abnormal CS0-
Week -8: Respiratory sys- Normal47-
Week -8: Respiratory sys- Abnormal NCS1-
Week -8: Respiratory sys- Abnormal CS0-
Week 26: Respiratory sys- Normal44-
Week 26: Respiratory sys- Abnormal NCS1-
Week 26: Respiratory sys- Abnormal CS0-
Week 52: Respiratory sys- Normal44-
Week 52: Respiratory sys- Abnormal NCS1-
Week 52: Respiratory sys- Abnormal CS0-
Week -8: Skin- Normal47-
Week -8: Skin- Abnormal NCS1-
Week -8: Skin- Abnormal CS0-
Week 26: Skin- Normal43-
Week 26: Skin- Abnormal NCS1-
Week 26: Skin- Abnormal CS1-
Week 52: Skin- Normal45-
Week 52: Skin- Abnormal NCS0-
Week 52: Skin- Abnormal CS0-
Week -8: Thyroid - Normal48-
Week -8: Thyroid- Abnormal NCS0-
Week -8: Thyroid- Abnormal CS0-
Week 26: Thyroid- Normal45-
Week 26: Thyroid- Abnormal NCS0-
Week 26: Thyroid- Abnormal CS0-
Week 52: Thyroid- Normal45-
Week 52: Thyroid- Abnormal NCS0-
Week 52: Thyroid- Abnormal CS0-
PlaceboWeek -8: Cardiovascular- Normal49-
Week -8: Cardiovascular- Abnormal NCS0-
Week -8: Cardiovascular- Abnormal CS0-
Week 26: Cardiovascular- Normal49-
Week 26: Cardiovascular- Abnormal NCS0-
Week 26: Cardiovascular- Abnormal CS0-
Week 52: Cardiovascular- Normal49-
Week 52: Cardiovascular- Abnormal NCS0-
Week 52: Cardiovascular- Abnormal CS0-
Week -8: Nervous system- Normal48-
Week -8: Nervous system- Abnormal NCS1-
Week -8: Nervous system- Abnormal CS0-
Week 26: Nervous system- Normal48-
Week 26: Nervous system- Abnormal NCS1-
Week 26: Nervous system- Abnormal CS0-
Week 52: Nervous system- Normal48-
Week 52: Nervous system- Abnormal NCS1-
Week 52: Nervous system- Abnormal CS0-
Week -8: Gastrointestinal sys- Normal48-
Week -8: Gastrointestinal sys- Abnormal NCS1-
Week -8: Gastrointestinal sys- Abnormal CS0-
Week 26: Gastrointestinal sys - Normal48-
Week 26: Gastrointestinal sys- Abnormal NCS1-
Week 26: Gastrointestinal sys- Abnormal CS0-
Week 52: Gastrointestinal sys- Normal47-
Week 52: Gastrointestinal sys- Abnormal NCS2-
Week 52: Gastrointestinal sys- Abnormal CS0-
Week -8: General appearance- Normal46-
Week -8: General appearance- Abnormal NCS3-
Week -8: General appearance- Abnormal CS0-
Week 26: General appearance- Normal46-
Week 26: General appearance- Abnormal NCS3-
Week 26: General appearance- Abnormal CS0-
Week 52: General appearance- Normal46-
Week 52: General appearance- Abnormal NCS3-
Week 52: General appearance- Abnormal CS0-
Week -8: Head and neck- Normal46-
Week -8: Head and neck- Abnormal NCS3-
Week -8: Head and neck- Abnormal CS0-
Week 26: Head and neck- Normal44-
Week 26: Head and neck- Abnormal NCS3-
Week 26: Head and neck- Abnormal CS2-
Week 52: Head and neck- Normal44-
Week 52: Head and neck- Abnormal NCS3-
Week 52: Head and neck- Abnormal CS2-
Week -8: Lymph node- Normal49-
Week -8: Lymph node- Abnormal NCS0-
Week -8: Lymph node- Abnormal CS0-
Week 26: Lymph node- Normal49-
Week 26: Lymph node- Abnormal NCS0-
Week 26: Lymph node- Abnormal CS0-
Week 52: Lymph node- Normal49-
Week 52: Lymph node- Abnormal NCS0-
Week 52: Lymph node- Abnormal CS0-
Week -8: Musculoskeletal- Normal44-
Week -8: Musculoskeletal- Abnormal NCS4-
Week -8: Musculoskeletal- Abnormal CS1-
Week 26: Musculoskeletal- Normal42-
Week 26: Musculoskeletal- Abnormal NCS6-
Week 26: Musculoskeletal- Abnormal CS1-
Week 52: Musculoskeletal- Normal43-
Week 52: Musculoskeletal- Abnormal NCS6-
Week 52: Musculoskeletal- Abnormal CS0-
Week -8: Respiratory sys- Normal49-
Week -8: Respiratory sys- Abnormal NCS0-
Week -8: Respiratory sys- Abnormal CS0-
Week 26: Respiratory sys- Normal49-
Week 26: Respiratory sys- Abnormal NCS0-
Week 26: Respiratory sys- Abnormal CS0-
Week 52: Respiratory sys- Normal49-
Week 52: Respiratory sys- Abnormal NCS0-
Week 52: Respiratory sys- Abnormal CS0-
Week -8: Skin- Normal45-
Week -8: Skin- Abnormal NCS2-
Week -8: Skin- Abnormal CS2-
Week 26: Skin- Normal45-
Week 26: Skin- Abnormal NCS2-
Week 26: Skin- Abnormal CS2-
Week 52: Skin- Normal46-
Week 52: Skin- Abnormal NCS2-
Week 52: Skin- Abnormal CS1-
Week -8: Thyroid - Normal49-
Week -8: Thyroid- Abnormal NCS0-
Week -8: Thyroid- Abnormal CS0-
Week 26: Thyroid- Normal49-
Week 26: Thyroid- Abnormal NCS0-
Week 26: Thyroid- Abnormal CS0-
Week 52: Thyroid- Normal49-
Week 52: Thyroid- Abnormal NCS0-
Week 52: Thyroid- Abnormal CS0-
Secondary/registry result/low confidence

Change in Eye Examination Category

Time frame:Week -8, Week 52

categorical status, event

Posted result

GroupParticipants95% CI
Oral Semaglutide 3 mgWeek -8: Left eye- Normal39-
Week -8: Left eye- Abnormal NCS4-
Week -8: Left eye- Abnormal CS6-
Week 52: Left eye- Normal36-
Week 52: Left eye- Abnormal NCS4-
Week 52: Left eye- Abnormal CS6-
Week -8: Right eye- Normal42-
Week -8: Right eye- Abnormal NCS2-
Week -8: Right eye- Abnormal CS5-
Week 52: Right eye- Normal39-
Week 52: Right eye- Abnormal NCS2-
Week 52: Right eye- Abnormal CS5-
Oral Semaglutide 7 mgWeek -8: Left eye- Normal45-
Week -8: Left eye- Abnormal NCS2-
Week -8: Left eye- Abnormal CS2-
Week 52: Left eye- Normal46-
Week 52: Left eye- Abnormal NCS2-
Week 52: Left eye- Abnormal CS1-
Week -8: Right eye- Normal46-
Week -8: Right eye- Abnormal NCS2-
Week -8: Right eye- Abnormal CS1-
Week 52: Right eye- Normal44-
Week 52: Right eye- Abnormal NCS2-
Week 52: Right eye- Abnormal CS3-
Oral Semaglutide 14 mgWeek -8: Left eye- Normal37-
Week -8: Left eye- Abnormal NCS4-
Week -8: Left eye- Abnormal CS7-
Week 52: Left eye- Normal38-
Week 52: Left eye- Abnormal NCS5-
Week 52: Left eye- Abnormal CS4-
Week -8: Right eye- Normal36-
Week -8: Right eye- Abnormal NCS5-
Week -8: Right eye- Abnormal CS7-
Week 52: Right eye- Normal36-
Week 52: Right eye- Abnormal NCS7-
Week 52: Right eye- Abnormal CS4-
Liraglutide 0.9 mgWeek -8: Left eye- Normal37-
Week -8: Left eye- Abnormal NCS6-
Week -8: Left eye- Abnormal CS5-
Week 52: Left eye- Normal37-
Week 52: Left eye- Abnormal NCS5-
Week 52: Left eye- Abnormal CS3-
Week -8: Right eye- Normal38-
Week -8: Right eye- Abnormal NCS7-
Week -8: Right eye- Abnormal CS3-
Week 52: Right eye- Normal39-
Week 52: Right eye- Abnormal NCS5-
Week 52: Right eye- Abnormal CS1-
PlaceboWeek -8: Left eye- Normal39-
Week -8: Left eye- Abnormal NCS5-
Week -8: Left eye- Abnormal CS5-
Week 52: Left eye- Normal41-
Week 52: Left eye- Abnormal NCS3-
Week 52: Left eye- Abnormal CS5-
Week -8: Right eye- Normal39-
Week -8: Right eye- Abnormal NCS4-
Week -8: Right eye- Abnormal CS6-
Week 52: Right eye- Normal44-
Week 52: Right eye- Abnormal NCS3-
Week 52: Right eye- Abnormal CS2-
Secondary/registry result

Anti-semaglutide Binding Antibodies (Yes/no)

Time frame:Week 0 - 57

Immunogenicity (ADA)

categorical status, event

Posted result

GroupParticipants95% CI
Oral Semaglutide 3 mgYes0-
No49-
Oral Semaglutide 7 mgYes1-
No48-
Oral Semaglutide 14 mgYes1-
No47-
Secondary/registry result

Anti-semaglutide Neutralising Antibodies (Yes/no)

Time frame:Week 0 - 57

Immunogenicity (ADA)

categorical status, event

Posted result

GroupParticipants95% CI
Oral Semaglutide 3 mgYes0-
No49-
Oral Semaglutide 7 mgYes0-
No49-
Oral Semaglutide 14 mgYes0-
No48-
Secondary/registry result

Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)

Time frame:Week 0 - 57

Immunogenicity (ADA)

threshold achievement, event

Posted result

GroupParticipants95% CI
Oral Semaglutide 3 mgYes0-
No49-
Oral Semaglutide 7 mgYes0-
No49-
Oral Semaglutide 14 mgYes1-
No47-
Secondary/registry result

Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)

Time frame:Week 0 - 57

Immunogenicity (ADA)

threshold achievement, event

Posted result

GroupParticipants95% CI
Oral Semaglutide 3 mgYes0-
No49-
Oral Semaglutide 7 mgYes0-
No49-
Oral Semaglutide 14 mgYes0-
No48-
Secondary/registry result

Anti-semaglutide Binding Antibody Levels

Time frame:Weeks 0-57

Immunogenicity (ADA)

descriptive

Posted result

GroupMean · %B/T95% CI
Oral Semaglutide 7 mgWeek 81.58-
Oral Semaglutide 14 mgWeek 382.40-
Secondary/registry result

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

GroupNumber · Episodes95% CI
Oral Semaglutide 3 mg0-
Oral Semaglutide 7 mg0-
Oral Semaglutide 14 mg0-
Liraglutide 0.9 mg2-
Placebo0-
Secondary/registry result

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

GroupParticipants95% CI
Oral Semaglutide 3 mg0-
Oral Semaglutide 7 mg0-
Oral Semaglutide 14 mg0-
Liraglutide 0.9 mg2-
Placebo0-
Secondary/registry result

Semaglutide Plasma Concentration

Time frame:Week 26 and week 52

Plasma concentration (steady state)

concentration, descriptive

Posted result

GroupGeometric mean · Nanomoles per liter (nmol/L)95% CI
Oral Semaglutide 3 mgWeek 26 pre-dose3.7-
Week 26 post-dose5.3-
Week 523.2-
Oral Semaglutide 7 mgWeek 26 pre-dose9.5-
Week 26 post-dose13.9-
Week 529.2-
Oral Semaglutide 14 mgWeek 26 pre-dose20.6-
Week 26 post-dose30.7-
Week 5220.0-
Secondary/protocol endpoint

Number of Treatment-emergent Adverse Events (TEAEs)

Time frame:Weeks 0 - 57

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Change in Amylase (Ratio to Baseine)

Time frame:Week 0, week 26, week 52

ratio, descriptive

Secondary/protocol endpoint

Change in Lipase (Ratio to Baseine)

Time frame:Week 0, week 26, week 52

ratio, descriptive

Secondary/protocol endpoint

Change in ECG Evaluation

Time frame:Week 0, week 26, week 52

categorical status, descriptive

Secondary/protocol endpoint

Change in Physical Examination

Time frame:Baseline (Week -8), week 26, week 52

categorical status, descriptive

Secondary/protocol endpoint

Anti-semaglutide Binding Antibodies (Yes/no)

Time frame:Week 0 - 57

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Anti-semaglutide Neutralising Antibodies (Yes/no)

Time frame:Week 0 - 57

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1 (Yes/no)

Time frame:Week 0 - 57

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Anti-semaglutide Neutralising Antibodies Cross Reacting With Native GLP-1 (Yes/no)

Time frame:Week 0 - 57

Immunogenicity (ADA)

categorical status, event

Secondary/protocol endpoint

Anti-semaglutide Binding Antibody Levels

Time frame:Weeks 0-57

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

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

Secondary/protocol endpoint

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

Secondary/protocol endpoint

Semaglutide Plasma Concentration

Time frame:Week 26 and week 52

Plasma concentration (steady state)

concentration, descriptive

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Change 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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

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 6, 2026 snapshot.