STEP 2

CompletedPhase 3Results posted

Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity

Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity and Type 2 Diabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

147

Recruiting sites

—

Enrollment

1,210

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥27•HbA1c 7-10%

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

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 IDNCT03552757

Org study IDNN9536-4374

Secondary ID2017-003414-10European Medicines Agency (EudraCT)

Secondary IDU1111-1200-8148World Health Organization (WHO)

Timeline

Milestones

Study start2018-06-04actual

Study first posted2018-06-12actual

Primary completion2020-03-24actual

Study completion2020-05-01actual

Results first posted2021-08-11actual

Last update posted2021-11-09actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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

•Body Mass Index (BMI) greater than or equal to 27 kg/m^2 '

•History of at least one self-reported unsuccessful dietary effort to lose body weight

•Diagnosed with type 2 diabetes (haemoglobin A1c 7-10% (53-86 mmol/mol) (both inclusive)) 180 days or longer prior to the day of screening

Exclusion criteria

•A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

•Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less than 30 mL/min/1.73 m^2 (less than 60 ml/min/1.73 m^2 in subjects treated with Sodium-glucose Cotransporter 2 Inhibitors) according to chronic kidney disease (CKD)-Epidemiology Collaboration (EPI) creatinine equation as defined by Kidney Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening

•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (e.g. optometrist) within the past 90 days prior to screening or in the period between screening and randomisation

Endpoints (82)

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

Cardiometabolic biomarkers

Weight & body composition

Glycemic / diabetes

Patient-reported / QoL

Safety / tolerability / PK

Other (unclassified)

Weight & body composition

20 endpoints

Primary/registry result

Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo

Time frame:Baseline (week 0) to week 68

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage point of body weight	95% CI
Semaglutide 2.4 mgIn-trial observation period	-9.9	—
On-treatment observation period	-10.7	—
PlaceboIn-trial observation period	-3.3	—
On-treatment observation period	-3.1	—

Treatment difference-6.2195% CI-7.28 – -5.15p<0.0001ANCOVA

Treatment difference-7.5795% CI-8.56 – -6.58p<0.0001MMRM

Primary/registry result

Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo

Time frame:At week 68

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mgIn-trial observation period	267	—
In-trial observation period	121	—
On-treatment observation period	257	—
On-treatment observation period	94	—
PlaceboIn-trial observation period	107	—
In-trial observation period	269	—
On-treatment observation period	94	—
On-treatment observation period	246	—

Odds Ratio (OR)4.8895% CI3.58 – 6.64p<0.0001Regression, Logistic

Odds Ratio (OR)8.6995% CI6.31 – 11.97p<0.0001Regression, Logistic

Primary/protocol endpoint

Change in Body Weight (%) - Semaglutide 2.4 mg Versus Placebo

Time frame:Baseline (week 0) to week 68

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Placebo

Time frame:At week 68

≥5% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg

Time frame:Baseline (week 0) to week 68

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage point of body weight	95% CI
Semaglutide 2.4 mg	-9.9	—
Semaglutide 1.0 mg	-7.2	—

Secondary/registry result

Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg

Time frame:At week 68

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	267	—
	121	—
Semaglutide 1.0 mg	217	—
	163	—

Secondary/registry result

Change in Waist Circumference

Time frame:Baseline (week 0) to week 68

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), Centimetre (cm)	95% CI
Semaglutide 1.0 mg	-6.9	—
Semaglutide 2.4 mg	-9.7	—
Placebo	-4.3	—

Secondary/registry result

Change in Body Weight (Kg)

Time frame:Baseline (week 0) to week 68

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram (kg)	95% CI
Semaglutide 1.0 mg	-7.1	—
Semaglutide 2.4 mg	-9.9	—
Placebo	-3.4	—

Secondary/registry result

Change in BMI

Time frame:Baseline (week 0) to week 68

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), kilogram per square meter (kg/m^2)	95% CI
Semaglutide 1.0 mg	-2.6	—
Semaglutide 2.4 mg	-3.6	—
Placebo	-1.2	—

Secondary/registry result

Participants Who Achieve (Yes/no): Body Weight Reduction ≥10%

Time frame:At week 68

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 1.0 mg	109	—
	271	—
Semaglutide 2.4 mg	177	—
	211	—
Placebo	31	—
	345	—

Secondary/registry result

Participants Who Achieve (Yes/no): Body Weight Reduction ≥15%

Time frame:At week 68

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 1.0 mg	52	—
	328	—
Semaglutide 2.4 mg	100	—
	288	—
Placebo	12	—
	364	—

Secondary/registry result

Participants Who Achieve (Yes/no): Body Weight Reduction ≥20%

Time frame:At week 68

≥20% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 1.0 mg	18	—
	362	—
Semaglutide 2.4 mg	51	—
	337	—
Placebo	6	—
	370	—

Secondary/protocol endpoint

Change in Body Weight (%) - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg

Time frame:Baseline (week 0) to week 68

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Participants Who Achieve (Yes/no): Body Weight Reduction ≥5% - Semaglutide 2.4 mg Versus Semaglutide 1.0 mg

Time frame:At week 68

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Baseline (week 0) to week 68

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight (Kg)

Time frame:Baseline (week 0) to week 68

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in BMI

Time frame:Baseline (week 0) to week 68

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Participants Who Achieve (Yes/no): Body Weight Reduction ≥10%

Time frame:At week 68

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participants Who Achieve (Yes/no): Body Weight Reduction ≥15%

Time frame:At week 68

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participants Who Achieve (Yes/no): Body Weight Reduction ≥20%

Time frame:At week 68

≥20% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

15 endpoints

Secondary/registry result

Change in HbA1c (%)

Time frame:Baseline (week 0) to week 68

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage point of HbA1c	95% CI
Semaglutide 1.0 mg	-1.5	—
Semaglutide 2.4 mg	-1.7	—
Placebo	-0.3	—

Secondary/registry result

Change in HbA1c (mmol/Mol)

Time frame:Baseline (week 0) to week 68

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), millimoles per mole (mmol/mol)	95% CI
Semaglutide 1.0 mg	-16.9	—
Semaglutide 2.4 mg	-18.7	—
Placebo	-3.4	—

Secondary/registry result

Change in FPG (mg/dL)

Time frame:Baseline (week 0) to week 68

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), milligrams per deciliter (mg/dL)	95% CI
Semaglutide 1.0 mg	-36.5	—
Semaglutide 2.4 mg	-37.9	—
Placebo	-2.3	—

Secondary/registry result

Change in Fasting Serum Insulin

Time frame:Baseline (week 0) to week 68

change from baseline, improvement

Posted result

Group	Value (geometric_mean), Picomoles per litre (pmol/L)	95% CI
Semaglutide 1.0 mg	0.94	—
Semaglutide 2.4 mg	0.90	—
Placebo	0.93	—

Secondary/registry result

Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol)

Time frame:At week 68

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 1.0 mg	272	—
	104	—
Semaglutide 2.4 mg	299	—
	82	—
Placebo	99	—
	275	—

Secondary/registry result

Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)

Time frame:At week 68

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 1.0 mg	226	—
	150	—
Semaglutide 2.4 mg	257	—
	124	—
Placebo	58	—
	316	—

Secondary/registry result

Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0%

Time frame:At week 68

threshold achievement, improvement

components≥10% weight-loss responders, HbA1c <7.0% achievement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 1.0 mg	105	—
	271	—
Semaglutide 2.4 mg	170	—
	211	—
Placebo	25	—
	349	—

Secondary/registry result

Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0%

Time frame:At week 68

threshold achievement, improvement

components≥15% weight-loss responders, HbA1c <7.0% achievement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 1.0 mg	49	—
	327	—
Semaglutide 2.4 mg	98	—
	283	—
Placebo	11	—
	363	—

Secondary/protocol endpoint

Change in HbA1c (%)

Time frame:Baseline (week 0) to week 68

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c (mmol/Mol)

Time frame:Baseline (week 0) to week 68

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in FPG (mg/dL)

Time frame:Baseline (week 0) to week 68

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Fasting Serum Insulin

Time frame:Baseline (week 0) to week 68

change from baseline, improvement

Secondary/protocol endpoint

Participants Who Achieve (Yes/no): HbA1c <7.0% (53 mmol/Mol)

Time frame:At week 68

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieve (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)

Time frame:At week 68

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants Who Achieve (Yes/no): Body Weight Reduction ≥10% and HbA1c <7.0%

Time frame:At week 68

threshold achievement, improvement

components≥10% weight-loss responders, HbA1c <7.0% achievement

Cardiometabolic biomarkers

22 endpoints

Secondary/registry result

Change in Systolic Blood Pressure

Time frame:Baseline (week 0) to week 68

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), Millimetre of mercury (mmHg)	95% CI
Semaglutide 1.0 mg	-3	—
Semaglutide 2.4 mg	-4	—
Placebo	0	—

Secondary/registry result

Change in Diastolic Blood Pressure

Time frame:Baseline (week 0) to week 68

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), Millimetre of mercury (mmHg)	95% CI
Semaglutide 1.0 mg	-1	—
Semaglutide 2.4 mg	-2	—
Placebo	-1	—

Secondary/registry result

Change in Total Cholesterol

Time frame:Baseline (week 0) to week 68

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Semaglutide 1.0 mg	0.97	—
Semaglutide 2.4 mg	0.99	—
Placebo	1.00	—

Secondary/registry result

Change in HDL Cholesterol

Time frame:Baseline (week 0) to week 68

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL cholesterol	95% CI
Semaglutide 1.0 mg	1.06	—
Semaglutide 2.4 mg	1.07	—
Placebo	1.04	—

Secondary/registry result

Change in LDL Cholesterol

Time frame:Baseline (week 0) to week 68

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL cholesterol	95% CI
Semaglutide 1.0 mg	0.99	—
Semaglutide 2.4 mg	1.00	—
Placebo	1.00	—

Secondary/registry result

Change in VLDL Cholesterol

Time frame:Baseline (week 0) to week 68

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of VLDL cholesterol	95% CI
Semaglutide 1.0 mg	0.82	—
Semaglutide 2.4 mg	0.80	—
Placebo	0.92	—

Secondary/registry result

Change in Free Fatty Acids

Time frame:Baseline (week 0) to week 68

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of free fatty acids	95% CI
Semaglutide 1.0 mg	0.85	—
Semaglutide 2.4 mg	0.84	—
Placebo	1.01	—

Secondary/registry result

Change in Triglycerides

Time frame:Baseline (week 0) to week 68

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Semaglutide 1.0 mg	0.81	—
Semaglutide 2.4 mg	0.79	—
Placebo	0.92	—

Secondary/registry result

Change in hsCRP

Time frame:Baseline (week 0) to week 68

hs-CRP, change

ratio, improvement

LOINC 30522-7

Posted result

Group	Value (geometric_mean), Ratio of hsCRP	95% CI
Semaglutide 1.0 mg	0.59	—
Semaglutide 2.4 mg	0.50	—
Placebo	0.84	—

Secondary/registry result

Change in PAI-1 Activity

Time frame:Baseline (week 0) to week 68

PAI-1 activity

change from baseline, improvement

Posted result

Group	Value (geometric_mean), Ratio of PAI-1 activity	95% CI
Semaglutide 1.0 mg	1.21	—
Semaglutide 2.4 mg	1.06	—
Placebo	1.42	—

Secondary/registry result

Change in Pulse - Semaglutide 2.4 mg Versus Placebo

Time frame:Baseline (week 0) to week 68

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats/minute	95% CI
Semaglutide 2.4 mg	2	—
Placebo	0	—

Secondary/protocol endpoint

Change in Systolic Blood Pressure

Time frame:Baseline (week 0) to week 68

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Diastolic Blood Pressure

Time frame:Baseline (week 0) to week 68

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in Total Cholesterol

Time frame:Baseline (week 0) to week 68

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in HDL Cholesterol

Time frame:Baseline (week 0) to week 68

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in LDL Cholesterol

Time frame:Baseline (week 0) to week 68

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in VLDL Cholesterol

Time frame:Baseline (week 0) to week 68

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Free Fatty Acids

Time frame:Baseline (week 0) to week 68

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change in Triglycerides

Time frame:Baseline (week 0) to week 68

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in hsCRP

Time frame:Baseline (week 0) to week 68

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in PAI-1 Activity

Time frame:Baseline (week 0) to week 68

ratio, improvement

Secondary/protocol endpoint

Change in Pulse - Semaglutide 2.4 mg Versus Placebo

Time frame:Baseline (week 0) to week 68

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

12 endpoints

Secondary/registry result

Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score)

Time frame:Baseline (week 0) to week 68

SF-36 physical

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide 1.0 mg	2.1	—
Semaglutide 2.4 mg	2.8	—
Placebo	0.8	—

Secondary/registry result

Change in SF-36 (All Scores Except Physical Functioning)

Time frame:Baseline (week 0) to week 68

SF-36 total

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide 1.0 mgRole-Physical	0.6	—
Bodily Pain	0.4	—
General Health	1.7	—
Vitality	-0.1	—
Social Functioning	-0.3	—
Role-Emotional	-0.4	—
Mental Health	-0.9	—
Physical component summary	1.9	—
Mental component summary	-1.4	—
Semaglutide 2.4 mgRole-Physical	0.8	—
Bodily Pain	0.3	—
General Health	2.2	—
Vitality	0.8	—
Social Functioning	0.2	—
Role-Emotional	-0.4	—
Mental Health	-0.4	—
Physical component summary	2.3	—
Mental component summary	-0.9	—
PlaceboRole-Physical	0.0	—
Bodily Pain	-0.4	—
General Health	0.6	—
Vitality	-0.9	—
Social Functioning	-0.7	—
Role-Emotional	-1.1	—
Mental Health	-1.6	—
Physical component summary	0.9	—
Mental component summary	-1.8	—

Secondary/registry result

Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score)

Time frame:Baseline (week 0) to week 68

IWQOL-Lite physical

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide 1.0 mg	8.5	—
Semaglutide 2.4 mg	11.4	—
Placebo	4.9	—

Secondary/registry result

Change in IWQOL-Lite for CT (All Scores Except Physical Function)

Time frame:Baseline (week 0) to week 68

IWQOL-Lite total

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide 1.0 mgPhysical	7.6	—
Psychosocial	8.6	—
Total	8.2	—
Semaglutide 2.4 mgPhysical	11.0	—
Psychosocial	9.6	—
Total	10.1	—
PlaceboPhysical	4.4	—
Psychosocial	5.6	—
Total	5.2	—

Secondary/registry result

Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score

Time frame:At week 68

SF-36 physical

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 1.0 mgYes (with threshold 4.3)	88	—
No (with threshold 4.3)	282	—
Yes (with threshold 3.7)	130	—
No (with threshold 3.7)	240	—
Semaglutide 2.4 mgYes (with threshold 4.3)	111	—
No (with threshold 4.3)	265	—
Yes (with threshold 3.7)	158	—
No (with threshold 3.7)	218	—
PlaceboYes (with threshold 4.3)	68	—
No (with threshold 4.3)	297	—
Yes (with threshold 3.7)	102	—
No (with threshold 3.7)	263	—

Secondary/registry result

Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score

Time frame:At week 68

IWQOL-Lite physical

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 1.0 mgYes (with threshold 20)	107	—
No (with threshold 20)	262	—
Yes (with threshold 14.6)	144	—
No (with threshold 14.6)	225	—
Semaglutide 2.4 mgYes (with threshold 20)	131	—
No (with threshold 20)	245	—
Yes (with threshold 14.6)	160	—
No (with threshold 14.6)	216	—
PlaceboYes (with threshold 20)	83	—
No (with threshold 20)	282	—
Yes (with threshold 14.6)	113	—
No (with threshold 14.6)	252	—

Secondary/protocol endpoint

Change in Short Form 36 v2.0 Acute (SF-36) (Physical Functioning Score)

Time frame:Baseline (week 0) to week 68

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change in SF-36 (All Scores Except Physical Functioning)

Time frame:Baseline (week 0) to week 68

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite for CT (Physical Function Domain (5-items) Score)

Time frame:Baseline (week 0) to week 68

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change in IWQOL-Lite for CT (All Scores Except Physical Function)

Time frame:Baseline (week 0) to week 68

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Participants Who Achieve (Yes/no): Responder Definition Value for SF-36 Physical Functioning Score

Time frame:At week 68

SF-36 physical

threshold achievement, improvement

Secondary/protocol endpoint

Participants Who Achieve (Yes/no): Responder Definition Value for IWQOL-Lite for CT Physical Function Domain (5-items) Score

Time frame:At week 68

IWQOL-Lite physical

threshold achievement, improvement

Safety / tolerability / PK

12 endpoints

Secondary/registry result

Number of TEAEs - Semaglutide 2.4 mg Versus Placebo

Time frame:Week 0 to week 75

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide 2.4 mg	2197	—
Placebo	1388	—

Secondary/registry result

Number of SAEs - Semaglutide 2.4 mg Versus Placebo

Time frame:Week 0 to week 75

Serious AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide 2.4 mg	71	—
Placebo	53	—

Secondary/registry result

Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo

Time frame:Week 0 to week 75

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Semaglutide 2.4 mg	51	—
Placebo	18	—

Secondary/registry result

Change in Amylase - Semaglutide 2.4 mg Versus Placebo

Time frame:Baseline (week 0) to week 68

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of amylase	95% CI
Semaglutide 2.4 mg	1.24	—
Placebo	1.06	—

Secondary/registry result

Change in Lipase - Semaglutide 2.4 mg Versus Placebo

Time frame:Baseline (week 0) to week 68

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of lipase	95% CI
Semaglutide 2.4 mg	1.41	—
Placebo	0.99	—

Secondary/registry result

Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo

Time frame:Baseline (week 0) to week 68

Thyroid event

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of calcitonin	95% CI
Semaglutide 2.4 mg	0.94	—
Placebo	0.96	—

Secondary/protocol endpoint

Number of TEAEs - Semaglutide 2.4 mg Versus Placebo

Time frame:Week 0 to week 75

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of SAEs - Semaglutide 2.4 mg Versus Placebo

Time frame:Week 0 to week 75

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Severe or Blood Glucose-confirmed Symptomatic Hypoglycaemia Episodes - Semaglutide 2.4 mg Versus Placebo

Time frame:Week 0 to week 75

Severe hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Change in Amylase - Semaglutide 2.4 mg Versus Placebo

Time frame:Baseline (week 0) to week 68

ratio, descriptive

Secondary/protocol endpoint

Change in Lipase - Semaglutide 2.4 mg Versus Placebo

Time frame:Baseline (week 0) to week 68

ratio, descriptive

Secondary/protocol endpoint

Change in Calcitonin - Semaglutide 2.4 mg Versus Placebo

Time frame:Baseline (week 0) to week 68

Thyroid event

ratio, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

Participants Who Achieve (Yes/no): Body Weight Reduction ≥15% and HbA1c <7.0%

Time frame:At week 68

threshold achievement, improvement

components≥15% weight-loss responders, HbA1c <7.0% achievement

Publications (7)

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

Proteomic signatures reflect effects of semaglutide treatment for MASH.
JHEP reports : innovation in hepatology2025 Oct (month)PMID40980163doi:10.1016/j.jhepr.2025.101521via clinicaltrials gov reference derived + pubmed nct search
Psychiatric Safety of Semaglutide for Weight Management in People Without Known Major Psychopathology: Post Hoc Analysis of the STEP 1, 2, 3, and 5 Trials.
JAMA internal medicine2024 Nov 1PMID39226070doi:10.1001/jamainternmed.2024.4346via clinicaltrials gov reference derived + pubmed nct search
Effects of Semaglutide on Albuminuria and Kidney Function in People With Overweight or Obesity With or Without Type 2 Diabetes: Exploratory Analysis From the STEP 1, 2, and 3 Trials.
Diabetes care2023 Apr 1PMID36801984doi:10.2337/dc22-1889via clinicaltrials gov reference derived + pubmed nct search
Confirmatory psychometric evaluations of the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT).
Clinical obesity2021 Oct (month)PMID34296522doi:10.1111/cob.12477via pubmed nct search
Semaglutide 2·4 mg once a week in adults with overweight or obesity, and type 2 diabetes (STEP 2): a randomised, double-blind, double-dummy, placebo-controlled, phase 3 trial.
Lancet (London, England)2021 Mar 13PMID33667417doi:10.1016/S0140-6736(21)00213-0via CT.gov reference + pubmed nct search
Semaglutide 2.4 mg for the Treatment of Obesity: Key Elements of the STEP Trials 1 to 5.
Obesity (Silver Spring, Md.)2020 Jun (month)PMID32441473doi:10.1002/oby.22794via CT.gov background + pubmed nct search
Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial.
Lancet (London, England)2018 Aug 25PMID30122305doi:10.1016/S0140-6736(18)31773-2via 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.