PIONEER 11

CompletedPhase 3Results posted

A Research Study Comparing a New Medicine Oral Semaglutide to Placebo in People With Type 2 Diabetes

China Multi-regional Clinical Trial: Efficacy and Safety of Oral Semaglutide Versus Placebo in Subjects With Type 2 Diabetes Mellitus Treated With Diet and Exercise Only

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

521

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

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

NCT IDNCT04109547

Org study IDNN9924-4338

Secondary ID2018-002590-22European Medicines Agency (EudraCT)

Secondary IDU1111-1188-1173World Health Organization (WHO)

Timeline

Milestones

Study first posted2019-09-30actual

Study start2019-10-01actual

Primary completion2021-09-23actual

Study completion2021-10-27actual

Results first posted2023-09-14actual

Last update posted2024-09-19actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 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.

•Male or female, age above or equal to 18 years at the time of signing informed consent.

For Algeria only: Male or female, age above or equal to 19 years at the time of signing the informed consent.

For Taiwan only: Male or female, age above or equal to 20 years at the time of signing the informed consent.

•Diagnosed with type 2 diabetes mellitus

•HbA1c between 7.0 -10.0% (53-86 mmol/mol) (both inclusive).

Exclusion criteria

•- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an highly effective contraceptive method.

•Family or personal history of multiple endocrine neoplasia type 2 (MEN 2) or medullary thyroid carcinoma (MTC). Family is defined as a first degree relative.

•History or presence of pancreatitis (acute or chronic).

•History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).

•Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening.

•Subjects 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.

•Renal impairment measured as estimated glomerular filtration rate (eGFR) below 60 mL/min/1.73 m^2 as per Chronic Kidney Disease Epidemiology Collaboration formula(CKD-EPI).

•Subjects with alanine aminotransferase (ALT) above 2.5 x upper limit of the normal (ULN).

•Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.

Endpoints (108)

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

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

MASH / liver

Renal / kidney

Other (unclassified)

Patient-reported / QoL

Other clinical outcomes

Weight & body composition

14 endpoints

Secondary/registry result

Change From Baseline in Body Weight (Kilograms [kg])

Time frame:Baseline (Week 0), Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kg	95% CI
Oral Semaglutide 3 mg	-1.1	—
Oral Semaglutide 7 mg	-2.2	—
Oral Semaglutide 14 mg	-3.1	—
Placebo	-1.1	—

Secondary/registry result

Change From Baseline in Body Weight (Percentage [%])

Time frame:Baseline (Week 0), Week 26

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Oral Semaglutide 3 mg	-1	—
Oral Semaglutide 7 mg	-3	—
Oral Semaglutide 14 mg	-4	—
Placebo	-1	—

Secondary/registry result

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline (Week 0), Week 26

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), kilograms per square meter (kg/m^2)	95% CI
Oral Semaglutide 3 mg	-0.4	—
Oral Semaglutide 7 mg	-0.8	—
Oral Semaglutide 14 mg	-1.1	—
Placebo	-0.4	—

Secondary/registry result

Change From Baseline in Waist Circumference

Time frame:Baseline (Week 0), Week 26

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), centimetres (cm)	95% CI
Oral Semaglutide 3 mg	-2.1	—
Oral Semaglutide 7 mg	-2.2	—
Oral Semaglutide 14 mg	-2.8	—
Placebo	-1.4	—

Secondary/registry result

Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no)

Time frame:Week 26

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mgYes	33	—
No	81	—
Oral Semaglutide 7 mgYes	49	—
No	68	—
Oral Semaglutide 14 mgYes	62	—
No	54	—
PlaceboYes	28	—
No	78	—

Secondary/registry result

Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no)

Time frame:Week 26

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mgYes	17	—
No	98	—
Oral Semaglutide 7 mgYes	29	—
No	90	—
Oral Semaglutide 14 mgYes	43	—
No	73	—
PlaceboYes	11	—
No	95	—

Secondary/registry result

Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no)

Time frame:Week 26

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mgYes	5	—
No	110	—
Oral Semaglutide 7 mgYes	7	—
No	112	—
Oral Semaglutide 14 mgYes	12	—
No	104	—
PlaceboYes	0	—
No	106	—

Secondary/protocol endpoint

Change From Baseline in Body Weight (Kilograms [kg])

Time frame:Baseline (Week 0), Week 26

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Weight (Percentage [%])

Time frame:Baseline (Week 0), Week 26

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline (Week 0), Week 26

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline (Week 0), Week 26

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved Body Weight Loss >= 3 Percent (Yes/no)

Time frame:Week 26

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved Body Weight Loss >= 5 Percent (Yes/no)

Time frame:Week 26

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved Body Weight Loss >= 10 Percent (Yes/no)

Time frame:Week 26

≥10% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

20 endpoints

Primary/registry result

Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Time frame:Baseline (Week 0), Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Oral Semaglutide 3 mg	-1.1	—
Oral Semaglutide 7 mg	-1.5	—
Oral Semaglutide 14 mg	-1.6	—
Placebo	-0.2	—

Treatment difference-1.595% CI-1.8 – -1.3p<0.0001MMRM

Treatment difference-1.495% CI-1.6 – -1.2p<0.0001MMRM

Treatment difference-1.095% CI-1.2 – -0.8p<0.0001MMRM

Primary/protocol endpoint

Change From Baseline in Glycosylated Haemoglobin (HbA1c)

Time frame:Baseline (Week 0), Week 26

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Baseline (Week 0), Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), milligrams per deciliter (mg/dL)	95% CI
Oral Semaglutide 3 mg	-19.07	—
Oral Semaglutide 7 mg	-32.28	—
Oral Semaglutide 14 mg	-32.50	—
Placebo	0.00	—

Secondary/registry result

Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile

Time frame:Baseline (Week 0), Week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Oral Semaglutide 3 mg	-29.4	—
Oral Semaglutide 7 mg	-43.0	—
Oral Semaglutide 14 mg	-44.5	—
Placebo	-10.3	—

Secondary/registry result

Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals)

Time frame:Baseline (Week 0), Week 26

Postprandial glucose

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Oral Semaglutide 3 mg	-14.5	—
Oral Semaglutide 7 mg	-20.0	—
Oral Semaglutide 14 mg	-27.9	—
Placebo	-6.7	—

Secondary/registry result

Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no)

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mgYes	75	—
No	39	—
Oral Semaglutide 7 mgYes	100	—
No	17	—
Oral Semaglutide 14 mgYes	92	—
No	24	—
PlaceboYes	27	—
No	79	—

Secondary/registry result

Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mgYes	53	—
No	61	—
Oral Semaglutide 7 mgYes	76	—
No	41	—
Oral Semaglutide 14 mgYes	76	—
No	40	—
PlaceboYes	12	—
No	94	—

Secondary/registry result

Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no)

Time frame:Week 26

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mgYes	67	—
No	47	—
Oral Semaglutide 7 mgYes	89	—
No	28	—
Oral Semaglutide 14 mgYes	87	—
No	29	—
PlaceboYes	19	—
No	87	—

Secondary/registry result

Number of Participants Who Achieved HbA1c < 7.0 Percent (53 mmol/Mol) Without Hypoglycaemia (Treatment-emergent Severe or Blood Glucose [BG] Confirmed Symptomatic Hypoglycaemic Episodes) and no Body Weight Gain (Yes/no)

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mgYes	54	—
No	60	—
Oral Semaglutide 7 mgYes	80	—
No	37	—
Oral Semaglutide 14 mgYes	84	—
No	32	—
PlaceboYes	19	—
No	87	—

Secondary/registry result

Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no)

Time frame:Week 26

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mgYes	26	—
No	88	—
Oral Semaglutide 7 mgYes	43	—
No	74	—
Oral Semaglutide 14 mgYes	53	—
No	63	—
PlaceboYes	10	—
No	96	—

Secondary/registry result

Time From First Dose to Initiation of Rescue Medication

Time frame:From baseline (Week 0) to Week 26

time to event, event

Posted result

Group	Value (median), Days	95% CI
Oral Semaglutide 3 mg	NA	NA – NA
Oral Semaglutide 7 mg	NA	NA – NA
Placebo	NA	NA – NA

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG)

Time frame:Baseline (Week 0), Week 26

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Fasting 7-point Self-measured Plasma Glucose (SMPG) Profile: Mean 7-point Profile

Time frame:Baseline (Week 0), Week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Fasting 7-point Self-measured Plasma Glucose Profile: Mean Postprandial Increment (Over All Meals)

Time frame:Baseline (Week 0), Week 26

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved HbA1c Less Than (<) 7.0 % (53 Millimoles Per Mole [mmol/Mol]) (American Diabetes Association (ADA) Target) (Yes/no)

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants Who Achieved HbA1c Less Than or Equal to (<=) 6.5 Percent (48 mmol/Mol) (American Association of Clinical Endocrinologists (AACE) Target) (Yes/no)

Time frame:Week 26

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants Who Achieved HbA1c Reduction Greater Than or Equal to (>=) 1 Percent (10.9 mmol/Mol) (Yes/no)

Time frame:Week 26

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Time frame:Week 26

HbA1c <7.0% achievement

threshold achievement, improvement

componentsHbA1c <7.0% achievement, Severe hypoglycemia, Documented hypoglycemia, Body weight, absolute change (kg)

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants Who Achieved HbA1c Reduction >= 1% (10.9 mmol/Mol) and Body Weight Loss >= 3 Percent (Yes/no)

Time frame:Week 26

threshold achievement, improvement

componentsHbA1c, change, Body weight, % change

Secondary/protocol endpoint

Time From First Dose to Initiation of Rescue Medication

Time frame:From baseline (Week 0) to Week 26

time to event, event

MASH / liver

5 endpoints

Secondary/registry result

Change From Baseline in Biochemistry - Alanine Aminotransferase (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ALT, change

ratio, improvement

LOINC 1742-6

Posted result

Group	Value (geometric_mean), Ratio of alanine aminotransferase	95% CI
Oral Semaglutide 3 mg	0.88	—
Oral Semaglutide 7 mg	0.89	—
Oral Semaglutide 14 mg	0.85	—
Placebo	0.88	—

Secondary/registry result

Change From Baseline in Biochemistry - Aspartate Aminotransferase (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

AST, change

ratio, improvement

LOINC 1920-8

Posted result

Group	Value (geometric_mean), Ratio of aspartate aminotransferase	95% CI
Oral Semaglutide 3 mg	0.91	—
Oral Semaglutide 7 mg	0.91	—
Oral Semaglutide 14 mg	0.90	—
Placebo	0.89	—

Secondary/protocol endpoint

Change From Baseline in Biochemistry - Alanine Aminotransferase (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ALT, change

ratio, improvement

LOINC 1742-6

Secondary/protocol endpoint

Change From Baseline in Biochemistry - Aspartate Aminotransferase (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

AST, change

ratio, improvement

LOINC 1920-8

Secondary/protocol endpoint

Change From Baseline in Biochemistry - Alkaline Phosphatase (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, improvement

Renal / kidney

5 endpoints

Secondary/registry result

Change From Baseline in Biochemistry - Creatinine (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of creatinine	95% CI
Oral Semaglutide 3 mg	1.03	—
Oral Semaglutide 7 mg	1.02	—
Oral Semaglutide 14 mg	1.03	—
Placebo	0.99	—

Secondary/registry result

Change From Baseline in Albumin (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of albumin	95% CI
Oral Semaglutide 3 mg	1.00	—
Oral Semaglutide 7 mg	0.99	—
Oral Semaglutide 14 mg	0.99	—
Placebo	0.99	—

Secondary/protocol endpoint/low confidence

Change From Baseline in Biochemistry - Urea (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, improvement

Secondary/protocol endpoint

Change From Baseline in Biochemistry - Creatinine (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, improvement

Secondary/protocol endpoint

Change From Baseline in Albumin (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, improvement

Cardiometabolic biomarkers

14 endpoints

Secondary/registry result

Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Oral Semaglutide 3 mg	0.99	—
Oral Semaglutide 7 mg	0.98	—
Oral Semaglutide 14 mg	0.94	—
Placebo	1.00	—

Secondary/registry result

Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL cholesterol	95% CI
Oral Semaglutide 3 mg	1.00	—
Oral Semaglutide 7 mg	1.00	—
Oral Semaglutide 14 mg	0.94	—
Placebo	1.00	—

Secondary/registry result

Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL cholesterol	95% CI
Oral Semaglutide 3 mg	1.03	—
Oral Semaglutide 7 mg	1.02	—
Oral Semaglutide 14 mg	1.02	—
Placebo	1.04	—

Secondary/registry result

Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Oral Semaglutide 3 mg	0.96	—
Oral Semaglutide 7 mg	0.90	—
Oral Semaglutide 14 mg	0.87	—
Placebo	0.93	—

Secondary/registry result

Change From Baseline in Pulse Rate

Time frame:Baseline (Week 0), Week 26

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute (beats/min)	95% CI
Oral Semaglutide 3 mg	2	—
Oral Semaglutide 7 mg	4	—
Oral Semaglutide 14 mg	5	—
Placebo	1	—

Secondary/registry result

Change From Baseline in Systolic Blood Pressure

Time frame:Baseline (Week 0), Week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), millimeters of mercury (mmHg)	95% CI
Oral Semaglutide 3 mg	1	—
Oral Semaglutide 7 mg	-2	—
Oral Semaglutide 14 mg	-4	—
Placebo	-2	—

Secondary/registry result

Change From Baseline in Diastolic Blood Pressure

Time frame:Baseline (Week 0), Week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mmHg	95% CI
Oral Semaglutide 3 mg	0	—
Oral Semaglutide 7 mg	-1	—
Oral Semaglutide 14 mg	-2	—
Placebo	-2	—

Secondary/protocol endpoint

Change From Baseline in Fasting Lipid Profile: Total Cholesterol (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein (LDL) Cholesterol (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein (HDL) Cholesterol (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change From Baseline in Fasting Lipid Profile: Triglycerides (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change From Baseline in Pulse Rate

Time frame:Baseline (Week 0), Week 26

Heart rate, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure

Time frame:Baseline (Week 0), Week 26

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline in Diastolic Blood Pressure

Time frame:Baseline (Week 0), Week 26

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Patient-reported / QoL

2 endpoints

Secondary/registry result

Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey

Time frame:Baseline (Week 0), Week 26

SF-36 total

change from baseline, improvement

Posted result

Group	Value (mean), Units on a score	95% CI
Oral Semaglutide 3 mgPhysical functioning	0.25	—
Role physical	0.34	—
Bodily pain	0.11	—
General health	2.01	—
Vitality	1.23	—
Social functioning	0.22	—
Role emotional	0.46	—
Mental health	0.22	—
Physical component score	0.66	—
Mental component score	0.51	—
Oral Semaglutide 7 mgPhysical functioning	0.97	—
Role physical	0.43	—
Bodily pain	-0.86	—
General health	2.51	—
Vitality	-0.23	—
Social functioning	0.25	—
Role emotional	0.58	—
Mental health	-0.38	—
Physical component score	0.88	—
Mental component score	-0.15	—
Oral Semaglutide 14 mgPhysical functioning	0.34	—
Role physical	-0.00	—
Bodily pain	-0.34	—
General health	1.32	—
Vitality	0.54	—
Social functioning	-0.60	—
Role emotional	0.33	—
Mental health	-0.30	—
Physical component score	0.39	—
Mental component score	-0.10	—
PlaceboPhysical functioning	0.87	—
Role physical	0.33	—
Bodily pain	0.49	—
General health	1.17	—
Vitality	0.49	—
Social functioning	0.98	—
Role emotional	-0.04	—
Mental health	0.05	—
Physical component score	0.94	—
Mental component score	0.08	—

Secondary/protocol endpoint

Change From Baseline in Short Form-36 Version 2 (SF-36v2) (Acute Version) Health Survey

Time frame:Baseline (Week 0), Week 26

SF-36 total

change from baseline, improvement

Safety / tolerability / PK

44 endpoints

Secondary/registry result

Semaglutide Plasma Concentrations

Time frame:Week 26: post dose any time

Plasma concentration (steady state)

concentration, descriptive

Posted result

Group	Value (geometric_mean), nanomoles per liter (nmol/L)	95% CI
Oral Semaglutide 3 mg	4.36	—
Oral Semaglutide 7 mg	11.22	—
Oral Semaglutide 14 mg	17.71	—

Secondary/registry result

Change From Baseline in Haematology - Haematocrit (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of haematocrit	95% CI
Oral Semaglutide 3 mg	1.00	—
Oral Semaglutide 7 mg	1.00	—
Oral Semaglutide 14 mg	1.00	—
Placebo	1.00	—

Secondary/registry result

Change From Baseline in Haematology - Haemoglobin (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of haemoglobin	95% CI
Oral Semaglutide 3 mg	1.01	—
Oral Semaglutide 7 mg	1.00	—
Oral Semaglutide 14 mg	1.00	—
Placebo	1.00	—

Secondary/registry result

Change From Baseline in Haematology - Leucocytes (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of leucocytes	95% CI
Oral Semaglutide 3 mg	1.03	—
Oral Semaglutide 7 mg	1.01	—
Oral Semaglutide 14 mg	1.04	—
Placebo	1.03	—

Secondary/registry result

Change From Baseline in Haematology - Thrombocytes (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of thrombocytes	95% CI
Oral Semaglutide 3 mg	1.03	—
Oral Semaglutide 7 mg	1.01	—
Oral Semaglutide 14 mg	1.04	—
Placebo	1.02	—

Secondary/registry result

Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils

Time frame:Baseline (Week 0), Week 26

change from baseline, descriptive

componentsbasophils, eosinophils, lymphocytes, monocytes, neutrophils

Posted result

Group	Value (mean), 10^9 cells per liters (10^9 cells/L)	95% CI
Oral Semaglutide 3 mgBasophils	0.00	—
Eosinophils	0.01	—
Lymphocytes	0.05	—
Monocytes	0.01	—
Neutrophils	0.18	—
Oral Semaglutide 7 mgBasophils	-0.01	—
Eosinophils	0.02	—
Lymphocytes	-0.03	—
Monocytes	-0.00	—
Neutrophils	0.06	—
Oral Semaglutide 14 mgBasophils	-0.01	—
Eosinophils	0.02	—
Lymphocytes	-0.09	—
Monocytes	0.01	—
Neutrophils	0.28	—
PlaceboBasophils	-0.01	—
Eosinophils	0.01	—
Lymphocytes	0.02	—
Monocytes	0.01	—
Neutrophils	0.21	—

Secondary/registry result

Change From Baseline in Biochemistry - Urea (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of urea	95% CI
Oral Semaglutide 3 mg	1.02	—
Oral Semaglutide 7 mg	1.00	—
Oral Semaglutide 14 mg	1.02	—
Placebo	1.07	—

Secondary/registry result

Change From Baseline in Biochemistry - Alkaline Phosphatase (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of alkaline phosphatase	95% CI
Oral Semaglutide 3 mg	0.94	—
Oral Semaglutide 7 mg	0.92	—
Oral Semaglutide 14 mg	0.95	—
Placebo	0.95	—

Secondary/registry result

Change From Baseline in Biochemistry - Total Bilirubin (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of total bilirubin	95% CI
Oral Semaglutide 3 mg	0.89	—
Oral Semaglutide 7 mg	0.84	—
Oral Semaglutide 14 mg	0.85	—
Placebo	0.95	—

Secondary/registry result

Change From Baseline in Biochemistry - Amylase (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of amylase	95% CI
Oral Semaglutide 3 mg	1.09	—
Oral Semaglutide 7 mg	1.20	—
Oral Semaglutide 14 mg	1.11	—
Placebo	1.05	—

Secondary/registry result

Change From Baseline in Biochemistry - Lipase (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of lipase	95% CI
Oral Semaglutide 3 mg	1.24	—
Oral Semaglutide 7 mg	1.60	—
Oral Semaglutide 14 mg	1.35	—
Placebo	1.05	—

Secondary/registry result

Change From Baseline in Biochemistry - Creatine Kinase (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of creatine kinase	95% CI
Oral Semaglutide 3 mg	1.06	—
Oral Semaglutide 7 mg	0.96	—
Oral Semaglutide 14 mg	1.00	—
Placebo	0.93	—

Secondary/registry result

Change From Baseline in Calcium (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of calcium	95% CI
Oral Semaglutide 3 mg	0.98	—
Oral Semaglutide 7 mg	0.97	—
Oral Semaglutide 14 mg	0.98	—
Placebo	0.97	—

Secondary/registry result

Change From Baseline in Potassium (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of potassium	95% CI
Oral Semaglutide 3 mg	1.02	—
Oral Semaglutide 7 mg	1.01	—
Oral Semaglutide 14 mg	1.00	—
Placebo	1.01	—

Secondary/registry result

Change From Baseline in Calcitonin (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

Thyroid event

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of calcitonin	95% CI
Oral Semaglutide 3 mg	1.01	—
Oral Semaglutide 7 mg	1.09	—
Oral Semaglutide 14 mg	1.15	—
Placebo	0.98	—

Secondary/registry result

Change From Baseline in Electrocardiogram (ECG) Category

Time frame:Baseline (Week 0), Week 26

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mgNormal (week 0) to normal (week 26)	53	—
Normal (week 0) to abnormal NCS (week 26)	12	—
Normal (week 0) to abnormal CS (week 26)	1	—
Abnormal NCS (week 0) to normal (week 26)	9	—
Abnormal NCS (week 0) to abnormal NCS (week 26)	26	—
Abnormal NCS (week 0) to abnormal CS (week 26)	2	—
Abnormal CS (week 0) to normal (week 26)	6	—
Abnormal CS (week 0) to abnormal NCS (week 26)	1	—
Abnormal CS (week 0) to abnormal CS (week 26)	11	—
Oral Semaglutide 7 mgNormal (week 0) to normal (week 26)	61	—
Normal (week 0) to abnormal NCS (week 26)	11	—
Normal (week 0) to abnormal CS (week 26)	3	—
Abnormal NCS (week 0) to normal (week 26)	11	—
Abnormal NCS (week 0) to abnormal NCS (week 26)	23	—
Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Abnormal CS (week 0) to normal (week 26)	4	—
Abnormal CS (week 0) to abnormal NCS (week 26)	1	—
Abnormal CS (week 0) to abnormal CS (week 26)	9	—
Oral Semaglutide 14 mgNormal (week 0) to normal (week 26)	59	—
Normal (week 0) to abnormal NCS (week 26)	9	—
Normal (week 0) to abnormal CS (week 26)	1	—
Abnormal NCS (week 0) to normal (week 26)	19	—
Abnormal NCS (week 0) to abnormal NCS (week 26)	23	—
Abnormal NCS (week 0) to abnormal CS (week 26)	1	—
Abnormal CS (week 0) to normal (week 26)	2	—
Abnormal CS (week 0) to abnormal NCS (week 26)	1	—
Abnormal CS (week 0) to abnormal CS (week 26)	4	—
PlaceboNormal (week 0) to normal (week 26)	58	—
Normal (week 0) to abnormal NCS (week 26)	5	—
Normal (week 0) to abnormal CS (week 26)	3	—
Abnormal NCS (week 0) to normal (week 26)	12	—
Abnormal NCS (week 0) to abnormal NCS (week 26)	33	—
Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Abnormal CS (week 0) to normal (week 26)	5	—
Abnormal CS (week 0) to abnormal NCS (week 26)	1	—
Abnormal CS (week 0) to abnormal CS (week 26)	4	—

Secondary/registry result

Change From Baseline in Physical Examination Category

Time frame:Baseline (Week 0), Week 26

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mgCardiovascular system - Normal (week 0) to normal (week 26)	113	—
Cardiovascular system - Normal (week 0) to abnormal NCS (week 26)	0	—
Cardiovascular system - Normal (week 0) to abnormal CS (week 26)	0	—
Cardiovascular system - Abnormal NCS (week 0) to normal (week 26)	3	—
Cardiovascular system - Abnormal NCS (week 0) to abnormal NCS (week 26)	5	—
Cardiovascular system - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Central and Peripheral Nervous System - Normal (week 0) to normal (week 26)	119	—
Central and Peripheral Nervous System - Normal (week 0) to abnormal NCS (week 26)	0	—
Central and Peripheral Nervous System - Normal (week 0) to abnormal CS (week 26)	0	—
Central and Peripheral Nervous System - Abnormal NCS (week 0) to normal (week 26)	0	—
Central and Peripheral Nervous System - Abnormal NCS (week 0) to abnormal NCS (week 26)	2	—
Central and Peripheral Nervous System - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Gastrointestinal System incl. Mouth - Normal (week 0) to normal (week 26)	117	—
Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal NCS (week 26)	1	—
Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal CS (week 26)	0	—
Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to normal (week 26)	2	—
Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal NCS (week 26)	1	—
Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
General Appearance - Normal (week 0) to normal (week 26)	115	—
General Appearance - Normal (week 0) to abnormal NCS (week 26)	1	—
General Appearance - Normal (week 0) to abnormal CS (week 26)	0	—
General Appearance - Abnormal NCS (week 0) to normal (week 26)	4	—
General Appearance - Abnormal NCS (week 0) to abnormal NCS (week 26)	0	—
General Appearance - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
General Appearance - Abnormal CS (week 0) to normal (week 26)	0	—
General Appearance - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
General Appearance - Abnormal CS (week 0) to abnormal CS (week 26)	1	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to normal (week 26)	121	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal NCS (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal CS (week 26)	0	—
Lymph Node Palpation - Normal (week 0) to normal (week 26)	120	—
Lymph Node Palpation - Normal (week 0) to abnormal NCS (week 26)	0	—
Lymph Node Palpation - Normal (week 0) to abnormal CS (week 26)	0	—
Lymph Node Palpation - Abnormal NCS (week 0) to normal (week 26)	1	—
Lymph Node Palpation - Abnormal NCS (week 0) to abnormal NCS (week 26)	0	—
Lymph Node Palpation - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Musculoskeletal System - Normal (week 0) to normal (week 26)	119	—
Musculoskeletal System - Normal (week 0) to abnormal NCS (week 26)	1	—
Musculoskeletal System - Normal (week 0) to abnormal CS (week 26)	0	—
Musculoskeletal System - Abnormal NCS (week 0) to normal (week 26)	0	—
Musculoskeletal System - Abnormal NCS (week 0) to abnormal NCS (week 26)	1	—
Musculoskeletal System - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Respiratory System - Normal (week 0) to normal (week 26)	121	—
Respiratory System - Normal (week 0) to abnormal NCS (week 26)	0	—
Respiratory System - Normal (week 0) to abnormal CS (week 26)	0	—
Respiratory System - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Skin - Normal (week 0) to normal (week 26)	99	—
Skin - Normal (week 0) to abnormal NCS (week 26)	1	—
Skin - Normal (week 0) to abnormal CS (week 26)	1	—
Skin - Abnormal NCS (week 0) to normal (week 26)	2	—
Skin - Abnormal NCS (week 0) to abnormal NCS (week 26)	11	—
Skin - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Skin - Abnormal CS (week 0) to normal (week 26)	0	—
Skin - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Skin - Abnormal CS (week 0) to abnormal CS (week 26)	7	—
Thyroid Gland - Normal (week 0) to normal (week 26)	119	—
Thyroid Gland - Normal (week 0) to abnormal NCS (week 26)	0	—
Thyroid Gland - Normal (week 0) to abnormal CS (week 26)	0	—
Thyroid Gland - Abnormal NCS (week 0) to normal (week 26)	0	—
Thyroid Gland - Abnormal NCS (week 0) to abnormal NCS (week 26)	2	—
Thyroid Gland - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Oral Semaglutide 7 mgCardiovascular system - Normal (week 0) to normal (week 26)	118	—
Cardiovascular system - Normal (week 0) to abnormal NCS (week 26)	0	—
Cardiovascular system - Normal (week 0) to abnormal CS (week 26)	0	—
Cardiovascular system - Abnormal NCS (week 0) to normal (week 26)	2	—
Cardiovascular system - Abnormal NCS (week 0) to abnormal NCS (week 26)	2	—
Cardiovascular system - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Central and Peripheral Nervous System - Normal (week 0) to normal (week 26)	121	—
Central and Peripheral Nervous System - Normal (week 0) to abnormal NCS (week 26)	0	—
Central and Peripheral Nervous System - Normal (week 0) to abnormal CS (week 26)	0	—
Central and Peripheral Nervous System - Abnormal CS (week 0) to normal (week 26)	0	—
Central and Peripheral Nervous System - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Central and Peripheral Nervous System - Abnormal CS (week 0) to abnormal CS (week 26)	1	—
Gastrointestinal System incl. Mouth - Normal (week 0) to normal (week 26)	117	—
Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal NCS (week 26)	0	—
Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal CS (week 26)	0	—
Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to normal (week 26)	0	—
Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal NCS (week 26)	3	—
Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Gastrointestinal System incl. Mouth - Abnormal CS (week 0) to normal (week 26)	0	—
Gastrointestinal System incl. Mouth - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Gastrointestinal System incl. Mouth - Abnormal CS (week 0) to abnormal CS (week 26)	2	—
General Appearance - Normal (week 0) to normal (week 26)	118	—
General Appearance - Normal (week 0) to abnormal NCS (week 26)	0	—
General Appearance - Normal (week 0) to abnormal CS (week 26)	0	—
General Appearance - Abnormal NCS (week 0) to normal (week 26)	2	—
General Appearance - Abnormal NCS (week 0) to abnormal NCS (week 26)	2	—
General Appearance - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to normal (week 26)	118	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal NCS (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal CS (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (week 0) to normal (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (week 0) to abnormal NCS (week 26)	1	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to normal (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to abnormal CS (week 26)	3	—
Lymph Node Palpation - Normal (week 0) to normal (week 26)	121	—
Lymph Node Palpation - Normal (week 0) to abnormal NCS (week 26)	0	—
Lymph Node Palpation - Normal (week 0) to abnormal CS (week 26)	0	—
Lymph Node Palpation - Abnormal NCS (week 0) to normal (week 26)	1	—
Lymph Node Palpation - Abnormal NCS (week 0) to abnormal NCS (week 26)	0	—
Lymph Node Palpation - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Musculoskeletal System - Normal (week 0) to normal (week 26)	119	—
Musculoskeletal System - Normal (week 0) to abnormal NCS (week 26)	0	—
Musculoskeletal System - Normal (week 0) to abnormal CS (week 26)	0	—
Musculoskeletal System - Abnormal NCS (week 0) to normal (week 26)	0	—
Musculoskeletal System - Abnormal NCS (week 0) to abnormal NCS (week 26)	1	—
Musculoskeletal System - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Musculoskeletal System - Abnormal CS (week 0) to normal (week 26)	1	—
Musculoskeletal System - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Musculoskeletal System - Abnormal CS (week 0) to abnormal CS (week 26)	1	—
Respiratory System - Normal (week 0) to normal (week 26)	122	—
Respiratory System - Normal (week 0) to abnormal NCS (week 26)	0	—
Respiratory System - Normal (week 0) to abnormal CS (week 26)	0	—
Respiratory System - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Skin - Normal (week 0) to normal (week 26)	106	—
Skin - Normal (week 0) to abnormal NCS (week 26)	0	—
Skin - Normal (week 0) to abnormal CS (week 26)	0	—
Skin - Abnormal NCS (week 0) to normal (week 26)	0	—
Skin - Abnormal NCS (week 0) to abnormal NCS (week 26)	7	—
Skin - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Skin - Abnormal CS (week 0) to normal (week 26)	2	—
Skin - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Skin - Abnormal CS (week 0) to abnormal CS (week 26)	7	—
Thyroid Gland - Normal (week 0) to normal (week 26)	120	—
Thyroid Gland - Normal (week 0) to abnormal NCS (week 26)	0	—
Thyroid Gland - Normal (week 0) to abnormal CS (week 26)	0	—
Thyroid Gland - Abnormal NCS (week 0) to normal (week 26)	0	—
Thyroid Gland - Abnormal NCS (week 0) to abnormal NCS (week 26)	2	—
Thyroid Gland - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Oral Semaglutide 14 mgCardiovascular system - Normal (week 0) to normal (week 26)	115	—
Cardiovascular system - Normal (week 0) to abnormal NCS (week 26)	0	—
Cardiovascular system - Normal (week 0) to abnormal CS (week 26)	0	—
Cardiovascular system - Abnormal NCS (week 0) to normal (week 26)	0	—
Cardiovascular system - Abnormal NCS (week 0) to abnormal NCS (week 26)	1	—
Cardiovascular system - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Central and Peripheral Nervous System - Normal (week 0) to normal (week 26)	116	—
Central and Peripheral Nervous System - Normal (week 0) to abnormal NCS (week 26)	0	—
Central and Peripheral Nervous System - Normal (week 0) to abnormal CS (week 26)	0	—
Gastrointestinal System incl. Mouth - Normal (week 0) to normal (week 26)	114	—
Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal NCS (week 26)	0	—
Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal CS (week 26)	0	—
Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to normal (week 26)	0	—
Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal NCS (week 26)	2	—
Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
General Appearance - Normal (week 0) to normal (week 26)	110	—
General Appearance - Normal (week 0) to abnormal NCS (week 26)	0	—
General Appearance - Normal (week 0) to abnormal CS (week 26)	0	—
General Appearance - Abnormal NCS (week 0) to normal (week 26)	1	—
General Appearance - Abnormal NCS (week 0) to abnormal NCS (week 26)	4	—
General Appearance - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
General Appearance - Abnormal CS (week 0) to normal (week 26)	0	—
General Appearance - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
General Appearance - Abnormal CS (week 0) to abnormal CS (week 26)	1	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to normal (week 26)	115	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal NCS (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal CS (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to normal (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to abnormal CS (week 26)	1	—
Lymph Node Palpation - Normal (week 0) to normal (week 26)	115	—
Lymph Node Palpation - Normal (week 0) to abnormal NCS (week 26)	0	—
Lymph Node Palpation - Normal (week 0) to abnormal CS (week 26)	0	—
Lymph Node Palpation - Abnormal NCS (week 0) to normal (week 26)	1	—
Lymph Node Palpation - Abnormal NCS (week 0) to abnormal NCS (week 26)	0	—
Lymph Node Palpation - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Musculoskeletal System - Normal (week 0) to normal (week 26)	115	—
Musculoskeletal System - Normal (week 0) to abnormal NCS (week 26)	0	—
Musculoskeletal System - Normal (week 0) to abnormal CS (week 26)	0	—
Musculoskeletal System - Abnormal NCS (week 0) to normal (week 26)	0	—
Musculoskeletal System - Abnormal NCS (week 0) to abnormal NCS (week 26)	1	—
Musculoskeletal System - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Respiratory System - Normal (week 0) to normal (week 26)	116	—
Respiratory System - Normal (week 0) to abnormal NCS (week 26)	0	—
Respiratory System - Normal (week 0) to abnormal CS (week 26)	0	—
Respiratory System - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Skin - Normal (week 0) to normal (week 26)	98	—
Skin - Normal (week 0) to abnormal NCS (week 26)	1	—
Skin - Normal (week 0) to abnormal CS (week 26)	0	—
Skin - Abnormal NCS (week 0) to normal (week 26)	3	—
Skin - Abnormal NCS (week 0) to abnormal NCS (week 26)	11	—
Skin - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Skin - Abnormal CS (week 0) to normal (week 26)	1	—
Skin - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Skin - Abnormal CS (week 0) to abnormal CS (week 26)	2	—
Thyroid Gland - Normal (week 0) to normal (week 26)	113	—
Thyroid Gland - Normal (week 0) to abnormal NCS (week 26)	0	—
Thyroid Gland - Normal (week 0) to abnormal CS (week 26)	0	—
Thyroid Gland - Abnormal NCS (week 0) to normal (week 26)	0	—
Thyroid Gland - Abnormal NCS (week 0) to abnormal NCS (week 26)	3	—
Thyroid Gland - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
PlaceboCardiovascular system - Normal (week 0) to normal (week 26)	115	—
Cardiovascular system - Normal (week 0) to abnormal NCS (week 26)	1	—
Cardiovascular system - Normal (week 0) to abnormal CS (week 26)	0	—
Cardiovascular system - Abnormal NCS (week 0) to normal (week 26)	0	—
Cardiovascular system - Abnormal NCS (week 0) to abnormal NCS (week 26)	4	—
Cardiovascular system - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Cardiovascular system - Abnormal CS (week 0) to normal (week 26)	0	—
Cardiovascular system - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Cardiovascular system - Abnormal CS (week 0) to abnormal CS (week 26)	1	—
Central and Peripheral Nervous System - Normal (week 0) to normal (week 26)	120	—
Central and Peripheral Nervous System - Normal (week 0) to abnormal NCS (week 26)	0	—
Central and Peripheral Nervous System - Normal (week 0) to abnormal CS (week 26)	0	—
Central and Peripheral Nervous System - Abnormal NCS (week 0) to normal (week 26)	0	—
Central and Peripheral Nervous System - Abnormal NCS (week 0) to abnormal NCS (week 26)	1	—
Central and Peripheral Nervous System - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Gastrointestinal System incl. Mouth - Normal (week 0) to normal (week 26)	115	—
Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal NCS (week 26)	0	—
Gastrointestinal System incl. Mouth - Normal (week 0) to abnormal CS (week 26)	0	—
Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to normal (week 26)	0	—
Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal NCS (week 26)	5	—
Gastrointestinal System incl. Mouth - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Gastrointestinal System incl. Mouth - Abnormal CS (week 0) to normal (week 26)	0	—
Gastrointestinal System incl. Mouth - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Gastrointestinal System incl. Mouth - Abnormal CS (week 0) to abnormal CS (week 26)	1	—
General Appearance - Normal (week 0) to normal (week 26)	119	—
General Appearance - Normal (week 0) to abnormal NCS (week 26)	0	—
General Appearance - Normal (week 0) to abnormal CS (week 26)	0	—
General Appearance - Abnormal NCS (week 0) to normal (week 26)	0	—
General Appearance - Abnormal NCS (week 0) to abnormal NCS (week 26)	1	—
General Appearance - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
General Appearance - Abnormal CS (week 0) to normal (week 26)	0	—
General Appearance - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
General Appearance - Abnormal CS (week 0) to abnormal CS (week 26)	1	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to normal (week 26)	117	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal NCS (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Normal (week 0) to abnormal CS (week 26)	1	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (week 0) to normal (week 26)	1	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (week 0) to abnormal NCS (week 26)	1	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to normal (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Head, Ears, Eyes, Nose, Throat, Neck - Abnormal CS (week 0) to abnormal CS (week 26)	1	—
Lymph Node Palpation - Normal (week 0) to normal (week 26)	119	—
Lymph Node Palpation - Normal (week 0) to abnormal NCS (week 26)	0	—
Lymph Node Palpation - Normal (week 0) to abnormal CS (week 26)	0	—
Lymph Node Palpation - Abnormal NCS (week 0) to normal (week 26)	2	—
Lymph Node Palpation - Abnormal NCS (week 0) to abnormal NCS (week 26)	0	—
Lymph Node Palpation - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Musculoskeletal System - Normal (week 0) to normal (week 26)	119	—
Musculoskeletal System - Normal (week 0) to abnormal NCS (week 26)	0	—
Musculoskeletal System - Normal (week 0) to abnormal CS (week 26)	1	—
Musculoskeletal System - Abnormal CS (week 0) to normal (week 26)	0	—
Musculoskeletal System - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Musculoskeletal System - Abnormal CS (week 0) to abnormal CS (week 26)	1	—
Respiratory System - Normal (week 0) to normal (week 26)	121	—
Respiratory System - Normal (week 0) to abnormal NCS (week 26)	0	—
Respiratory System - Normal (week 0) to abnormal CS (week 26)	0	—
Respiratory System - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Skin - Normal (week 0) to normal (week 26)	105	—
Skin - Normal (week 0) to abnormal NCS (week 26)	0	—
Skin - Normal (week 0) to abnormal CS (week 26)	0	—
Skin - Abnormal NCS (week 0) to normal (week 26)	3	—
Skin - Abnormal NCS (week 0) to abnormal NCS (week 26)	9	—
Skin - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Skin - Abnormal CS (week 0) to normal (week 26)	1	—
Skin - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Skin - Abnormal CS (week 0) to abnormal CS (week 26)	3	—
Thyroid Gland - Normal (week 0) to normal (week 26)	119	—
Thyroid Gland - Normal (week 0) to abnormal NCS (week 26)	0	—
Thyroid Gland - Normal (week 0) to abnormal CS (week 26)	0	—
Thyroid Gland - Abnormal NCS (week 0) to normal (week 26)	0	—
Thyroid Gland - Abnormal NCS (week 0) to abnormal NCS (week 26)	1	—
Thyroid Gland - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Thyroid Gland - Abnormal CS (week 0) to normal (week 26)	0	—
Thyroid Gland - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Thyroid Gland - Abnormal CS (week 0) to abnormal CS (week 26)	1	—

Secondary/registry result

Change From Baseline in Eye Examination Category

Time frame:Baseline (Week 0), Week 26

categorical status, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mgLeft Eye Ophthalmoscopy - Normal (week 0) to normal (week 26)	73	—
Left Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26)	6	—
Left Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26)	2	—
Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26)	10	—
Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26)	15	—
Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26)	4	—
Left Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26)	2	—
Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26)	8	—
Right Eye Ophthalmoscopy - Normal (week 0) to normal (week 26)	76	—
Right Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26)	6	—
Right Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26)	3	—
Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26)	8	—
Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26)	14	—
Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26)	4	—
Right Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26)	2	—
Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26)	7	—
Oral Semaglutide 7 mgLeft Eye Ophthalmoscopy - Normal (week 0) to normal (week 26)	77	—
Left Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26)	5	—
Left Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26)	4	—
Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26)	2	—
Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26)	19	—
Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26)	2	—
Left Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26)	4	—
Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26)	1	—
Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26)	7	—
Right Eye Ophthalmoscopy - Normal (week 0) to normal (week 26)	76	—
Right Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26)	6	—
Right Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26)	4	—
Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26)	3	—
Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26)	18	—
Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26)	1	—
Right Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26)	3	—
Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26)	1	—
Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26)	9	—
Oral Semaglutide 14 mgLeft Eye Ophthalmoscopy - Normal (week 0) to normal (week 26)	83	—
Left Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26)	5	—
Left Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26)	2	—
Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26)	1	—
Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26)	15	—
Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26)	1	—
Left Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26)	4	—
Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26)	8	—
Right Eye Ophthalmoscopy - Normal (week 0) to normal (week 26)	82	—
Right Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26)	4	—
Right Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26)	3	—
Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26)	3	—
Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26)	15	—
Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26)	1	—
Right Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26)	5	—
Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26)	1	—
Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26)	5	—
PlaceboLeft Eye Ophthalmoscopy - Normal (week 0) to normal (week 26)	75	—
Left Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26)	5	—
Left Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26)	5	—
Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26)	2	—
Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26)	18	—
Left Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Left Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26)	7	—
Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Left Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26)	9	—
Right Eye Ophthalmoscopy - Normal (week 0) to normal (week 26)	74	—
Right Eye Ophthalmoscopy - Normal (week 0) to abnormal NCS (week 26)	5	—
Right Eye Ophthalmoscopy - Normal (week 0) to abnormal CS (week 26)	3	—
Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to normal (week 26)	3	—
Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal NCS (week 26)	19	—
Right Eye Ophthalmoscopy - Abnormal NCS (week 0) to abnormal CS (week 26)	0	—
Right Eye Ophthalmoscopy - Abnormal CS (week 0) to normal (week 26)	8	—
Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal NCS (week 26)	0	—
Right Eye Ophthalmoscopy - Abnormal CS (week 0) to abnormal CS (week 26)	9	—

Secondary/registry result

Number of Treatment-emergent Adverse Events (TEAEs)

Time frame:Up to 31 weeks

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Oral Semaglutide 3 mg	251	—
Oral Semaglutide 7 mg	292	—
Oral Semaglutide 14 mg	231	—
Placebo	212	—

Secondary/registry result

Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Up to 31 weeks

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	—
Placebo	0	—

Secondary/registry result

Number of Participants With Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Up to 31 weeks

Documented hypoglycemia

event count, 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	—
Placebo	0	—

Secondary/registry result

Anti-semaglutide Binding Antibody Levels

Time frame:Up to 31 weeks

Immunogenicity (ADA)

descriptive

Posted result

Group	Value (mean), %B/T	95% CI
Oral Semaglutide 7 mg	2.1	—

Secondary/registry result

Number of Participants With Anti-semaglutide Binding Antibodies

Time frame:Up to 31 weeks

Immunogenicity (ADA)

threshold achievement, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Oral Semaglutide 3 mg	0	—
Oral Semaglutide 7 mg	1	—
Oral Semaglutide 14 mg	0	—

Secondary/registry result

Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1

Time frame:Up to 31 weeks

Immunogenicity (ADA)

threshold achievement, event

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	—

Secondary/protocol endpoint

Semaglutide Plasma Concentrations

Time frame:Week 26: post dose any time

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Change From Baseline in Haematology - Haematocrit (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline in Haematology - Haemoglobin (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline in Haematology - Leucocytes (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline in Haematology - Thrombocytes (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

LOINC 777-3

Secondary/protocol endpoint

Change From Baseline in Haematology - Basophils, Eosinophils, Lymphocytes, Monocytes and Neutrophils

Time frame:Baseline (Week 0), Week 26

change from baseline, descriptive

Secondary/protocol endpoint

Change From Baseline in Biochemistry - Total Bilirubin (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline in Biochemistry - Amylase (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline in Biochemistry - Lipase (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline in Biochemistry - Creatine Kinase (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline in Potassium (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline in Calcitonin (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

Thyroid event

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline in Electrocardiogram (ECG) Category

Time frame:Baseline (Week 0), Week 26

categorical status, descriptive

Secondary/protocol endpoint

Change From Baseline in Physical Examination Category

Time frame:Baseline (Week 0), Week 26

descriptive

Secondary/protocol endpoint

Number of Treatment-emergent Adverse Events (TEAEs)

Time frame:Up to 31 weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Up to 31 weeks

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of Participants With Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes

Time frame:Up to 31 weeks

Severe hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Anti-semaglutide Binding Antibody Levels

Time frame:Up to 31 weeks

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

Number of Participants With Anti-semaglutide Binding Antibodies

Time frame:Up to 31 weeks

Immunogenicity (ADA)

threshold achievement, event

Secondary/protocol endpoint

Number of Participants With Anti-semaglutide Binding Antibodies Cross Reacting With Native GLP-1

Time frame:Up to 31 weeks

Immunogenicity (ADA)

event count, event

Other clinical outcomes

1 endpoint

Secondary/protocol endpoint

Change From Baseline in Eye Examination Category

Time frame:Baseline (Week 0), Week 26

categorical status, improvement

Other (unclassified)

3 endpoints

Secondary/registry result/low confidence

Change From Baseline in Sodium (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of sodium	95% CI
Oral Semaglutide 3 mg	1.00	—
Oral Semaglutide 7 mg	1.00	—
Oral Semaglutide 14 mg	1.00	—
Placebo	1.00	—

Secondary/protocol endpoint/low confidence

Change From Baseline in Calcium (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Secondary/protocol endpoint/low confidence

Change From Baseline in Sodium (Ratio to Baseline)

Time frame:Baseline (Week 0), Week 26

ratio, descriptive

Publications (1)

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

Efficacy and safety of oral semaglutide monotherapy vs placebo in a predominantly Chinese population with type 2 diabetes (PIONEER 11): a double-blind, Phase IIIa, randomised trial.
Diabetologia2024 Sep (month)PMID38985162doi:10.1007/s00125-024-06142-3via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 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 1, 2026 snapshot.