← Trials/Trial dossier/NCT04251156

STEP7

CompletedPhase 3Results posted

Research Study of How Well Semaglutide Works in People Living With Overweight or Obesity.

Effect and Safety of Semaglutide 2.4 mg Once-weekly on Weight Management in Subjects With Overweight or Obesity.

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

375

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•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 IDNCT04251156

Org study IDNN9536-4379

Secondary IDU1111-1212-2189World Health Organization (WHO)

Timeline

Milestones

Study first posted2020-01-31actual

Study start2020-12-08actual

Primary completion2022-08-23actual

Study completion2022-08-23actual

Results first posted2024-11-29actual

Last update posted2026-01-29actual

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 18 years or older at the time of signing informed consent

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

For subjects without T2D at screening:

•Body mass index (BMI) of :

•greater than or equal to 30 kg/m^2

•greater than or equal to 27 kg/m^2 with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

For subjects with T2D at screening:

•Diagnosed with T2D above or equal to 180 days prior to the day of screening

•Treated with either:

•diet and exercise alone or

•stable treatment (same drug(s), dose and dosing frequency) for at least 60 days prior to the day of screening with up to 3 oral antidiabetic medications alone or in any combination (metformin, α-glucosidase inhibitor (AGI), SU, glinides, SGLT2i or glitazone) according to local label

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

•BMI greater than or equal to 27 kg/m^2

Exclusion criteria

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

For subjects without T2D at screening:

- HbA1c equal to or above 6.5% (48 mmol/mol) as measured by the central laboratory at screening

For subjects with T2D at screening :

•Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 mL/min/1.73 m^2 (below 60 mL/min/1.73 m^2 in subjects treated with SGLT2i) according to CKDEPI creatinine equation as defined by KDIGO 2012 by the central laboratory at screening

•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Endpoints (86)

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

Safety / tolerability / PK

Weight & body composition

Glycemic / diabetes

Patient-reported / QoL

MASH / liver

Other (unclassified)

Weight & body composition

16 endpoints

Primary/registry result

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

Time frame:Baseline (week 0), week 44

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Semaglutide 2.4 mg	-12.5	—
Placebo	-3.6	—

Treatment difference-8.4795% CI-10.17 – -6.76p<0.0001ANCOVA

Treatment policy estimand

Primary/registry result

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 5% (Yes/No)

Time frame:At week 44

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	203	—
	35	—
Placebo	36	—
	80	—

Odds Ratio (OR)13.0795% CI7.40 – 23.10p<0.0001Regression, Logistic

Treatment policy estimand

Primary/protocol endpoint

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

Time frame:Baseline (week 0), week 44

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 5% (Yes/No)

Time frame:At week 44

≥5% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 10% (Yes/No)

Time frame:At week 44

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	151	—
	87	—
Placebo	12	—
	104	—

Secondary/registry result

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 15% (Yes/No)

Time frame:At week 44

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	82	—
	156	—
Placebo	7	—
	109	—

Secondary/registry result

Change From Baseline in Waist Circumference

Time frame:Baseline (week 0), week 44

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), Centimeter (cm)	95% CI
Semaglutide 2.4 mg	-11.1	—
Placebo	-3.8	—

Secondary/registry result

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

Time frame:Baseline (week 0), week 44

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram (kg)	95% CI
Semaglutide 2.4 mg	-11.9	—
Placebo	-3.4	—

Secondary/registry result

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline (week 0), week 44

BMI, change

change from baseline, improvement

Posted result

Group	Value (mean), Kilograms per square meter (kg/m^2)	95% CI
Semaglutide 2.4 mg	-4.3	—
Placebo	-1.2	—

Secondary/registry result

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 20% (Yes/No)

Time frame:At week 44

≥20% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	34	—
	204	—
Placebo	2	—
	114	—

Secondary/protocol endpoint

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 10% (Yes/No)

Time frame:At week 44

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 15% (Yes/No)

Time frame:At week 44

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference

Time frame:Baseline (week 0), week 44

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline (week 0), week 44

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI)

Time frame:Baseline (week 0), week 44

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved Body Weight Reduction Greater Than or Equal (>=) to 20% (Yes/No)

Time frame:At week 44

≥20% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

16 endpoints

Secondary/registry result

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%])

Time frame:Baseline (week 0), week 44

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Semaglutide 2.4 mg	-0.8	—
Placebo	-0.1	—

Secondary/registry result

Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol])

Time frame:Baseline (week 0), week 44

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Millimoles per mole (mmol/mol)	95% CI
Semaglutide 2.4 mg	-8.9	—
Placebo	-1.3	—

Secondary/registry result

Change From Baseline in Fasting Plasma Glucose (FPG) (Milligrams Per Deciliter [mg/dL])

Time frame:Baseline (week 0), week 44

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Milligrams per deciliter (mg/dL)	95% CI
Semaglutide 2.4 mg	-18.9	—
Placebo	-1.1	—

Secondary/registry result

Change From Baseline in FPG (Millimoles Per Liter [mmol/L])

Time frame:Baseline (week 0), week 44

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), Millimoles per litre (mmol/L)	95% CI
Semaglutide 2.4 mg	-1.1	—
Placebo	-0.1	—

Secondary/registry result

Change From Baseline in Fasting Serum Insulin: Ratio to Baseline

Time frame:Baseline (week 0), week 44

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting serum insulin	95% CI
Semaglutide 2.4 mg	0.76	—
Placebo	0.98	—

Secondary/registry result

Number of Participants With Type 2 Diabetes (T2D) Who Achieved HbA1c Less Than (<) 7.0 Percent (%) (53 mmol/Mol)

Time frame:At week 44

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	57	—
	5	—
Placebo	8	—
	20	—

Secondary/registry result

Number of Participants With T2D Who Achieved HbA1c Less Than or Equal to (<=) 6.5% (48 mmol/Mol)

Time frame:At week 44

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	51	—
	11	—
Placebo	4	—
	24	—

Secondary/registry result

Change From Baseline in Glycaemic Category (Normo-Glycaemia, Pre-Diabetes, T2D) in Participants With no T2D at Baseline

Time frame:Baseline (week 0), week 44

categorical status, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mgNormo-glycaemia	158	—
Pre-diabetes	15	—
Diabetes	0	—
PlaceboNormo-glycaemia	53	—
Pre-diabetes	29	—
Diabetes	2	—

Secondary/protocol endpoint

Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%])

Time frame:Baseline (week 0), week 44

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol])

Time frame:Baseline (week 0), week 44

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose (FPG) (Milligrams Per Deciliter [mg/dL])

Time frame:Baseline (week 0), week 44

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in FPG (Millimoles Per Liter [mmol/L])

Time frame:Baseline (week 0), week 44

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Fasting Serum Insulin: Ratio to Baseline

Time frame:Baseline (week 0), week 44

ratio, improvement

Secondary/protocol endpoint

Number of Participants With Type 2 Diabetes (T2D) Who Achieved HbA1c Less Than (<) 7.0 Percent (%) (53 mmol/Mol)

Time frame:At week 44

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants With T2D Who Achieved HbA1c Less Than or Equal to (<=) 6.5% (48 mmol/Mol)

Time frame:At week 44

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Glycaemic Category (Normo-Glycaemia, Pre-Diabetes, T2D) in Participants With no T2D at Baseline

Time frame:Baseline (week 0), week 44

categorical status, improvement

MASH / liver

2 endpoints

Secondary/registry result

Change From Baseline in Number of Participants in Fatty Liver Index (FLI) Score Category

Time frame:Baseline (week 0), week 44

categorical status, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg<30	67	—
30<= to <60	62	—
>=60	107	—
Placebo<30	8	—
30<= to <60	17	—
>=60	88	—

Secondary/protocol endpoint

Change From Baseline in Number of Participants in Fatty Liver Index (FLI) Score Category

Time frame:Baseline (week 0), week 44

categorical status, improvement

Cardiometabolic biomarkers

21 endpoints

Secondary/registry result

Change From Baseline in Systolic Blood Pressure

Time frame:Baseline (week 0), week 44

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Posted result

Group	Value (mean), Millimeters of mercury (mmHg)	95% CI
Semaglutide 2.4 mg	-7	—
Placebo	-2	—

Secondary/registry result

Change From Baseline in Diastolic Blood Pressure

Time frame:Baseline (week 0), week 44

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Posted result

Group	Value (mean), mmHg	95% CI
Semaglutide 2.4 mg	-4	—
Placebo	-1	—

Secondary/registry result

Change From Baseline in Total Cholesterol: Ratio to Baseline

Time frame:Baseline (week 0), week 44

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Semaglutide 2.4 mg	0.94	—
Placebo	1.04	—

Secondary/registry result

Change From Baseline in High-Density Lipoproteins (HDL)-Ratio to Baseline

Time frame:Baseline (week 0), week 44

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL	95% CI
Semaglutide 2.4 mg	1.05	—
Placebo	1.08	—

Secondary/registry result

Change From Baseline in Low-Density Lipoproteins (LDL)-Ratio to Baseline

Time frame:Baseline (week 0), week 44

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL	95% CI
Semaglutide 2.4 mg	0.97	—
Placebo	1.04	—

Secondary/registry result

Change From Baseline in Very Low-Density Lipoproteins (VLDL)-Ratio to Baseline

Time frame:Baseline (week 0), week 44

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of VLDL	95% CI
Semaglutide 2.4 mg	0.71	—
Placebo	0.96	—

Secondary/registry result

Change From Baseline in Free Fatty Acids-Ratio to Baseline

Time frame:Baseline (week 0), week 44

Free fatty acids, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of free fatty acids	95% CI
Semaglutide 2.4 mg	0.91	—
Placebo	1.05	—

Secondary/registry result

Change From Baseline in Triglycerides-Ratio to Baseline

Time frame:Baseline (week 0), week 44

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Semaglutide 2.4 mg	0.71	—
Placebo	0.96	—

Secondary/registry result

Change From Baseline in Number of Participants With Antihypertensive Medication (Decrease, No Change, Increase)

Time frame:Baseline (week 0), week 44

categorical status, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mgDecreased	8	—
No change	57	—
Increased	9	—
PlaceboDecreased	2	—
No change	23	—
Increased	4	—

Secondary/registry result

Change From Baseline in Pulse

Time frame:Baseline (week 0), week 44

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute (bpm)	95% CI
Semaglutide 2.4 mg	4	—
Placebo	1	—

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure

Time frame:Baseline (week 0), week 44

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 44

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change From Baseline in Total Cholesterol: Ratio to Baseline

Time frame:Baseline (week 0), week 44

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change From Baseline in High-Density Lipoproteins (HDL)-Ratio to Baseline

Time frame:Baseline (week 0), week 44

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change From Baseline in Low-Density Lipoproteins (LDL)-Ratio to Baseline

Time frame:Baseline (week 0), week 44

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change From Baseline in Very Low-Density Lipoproteins (VLDL)-Ratio to Baseline

Time frame:Baseline (week 0), week 44

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change From Baseline in Free Fatty Acids-Ratio to Baseline

Time frame:Baseline (week 0), week 44

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change From Baseline in Triglycerides-Ratio to Baseline

Time frame:Baseline (week 0), week 44

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change From Baseline in Number of Participants With Antihypertensive Medication (Decrease, No Change, Increase)

Time frame:Baseline (week 0), week 44

categorical status, improvement

Secondary/protocol endpoint

Change From Baseline in Number of Participants With Lipid-Lowering Medication (Decrease, No Change, Increase)

Time frame:Baseline (week 0), week 44

categorical status, descriptive

Secondary/protocol endpoint

Change From Baseline in Pulse

Time frame:Baseline (week 0), week 44

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

12 endpoints

Secondary/registry result

Change From Baseline in Short Form-36 (SF-36) - Physical Functioning Score

Time frame:Baseline (week 0), week 44

SF-36 physical

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide 2.4 mg	1.3	—
Placebo	0.2	—

Secondary/registry result

Change From Baseline in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT) - Physical Function Domain (5-items) Score

Time frame:Baseline (week 0), week 44

IWQOL-Lite physical

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide 2.4 mg	8.0	—
Placebo	2.3	—

Secondary/registry result

Change From Baseline in SF-36 All Domains (Except Physical Functioning) and 2 Component Summary Scores

Time frame:Baseline (week 0), week 44

SF-36 total

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide 2.4 mgRole-Physical	0.5	—
Bodily Pain	-0.3	—
General Health	3.2	—
Vitality	0.3	—
Social Functioning	-0.5	—
Role-Emotional	0.5	—
Mental Health	-0.1	—
Physical component summary	1.4	—
Mental component summary	-0.3	—
PlaceboRole-Physical	-0.8	—
Bodily Pain	-1.2	—
General Health	1.6	—
Vitality	-1.1	—
Social Functioning	-0.5	—
Role-Emotional	-0.9	—
Mental Health	-1.8	—
Physical component summary	0.4	—
Mental component summary	-1.5	—

Secondary/registry result

Change From Baseline in IWQOL-Lite for Physical Domain Score, Psychological Domain Score and Total Score

Time frame:Baseline (week 0), week 44

IWQOL-Lite total

change from baseline, improvement

Posted result

Group	Value (mean), Score on a scale	95% CI
Semaglutide 2.4 mgPhysical	7.2	—
Psychosocial	12.0	—
Total	10.3	—
PlaceboPhysical	2.0	—
Psychosocial	4.8	—
Total	3.8	—

Secondary/registry result

Number of Participants Who Achieved Responder Definition Value for SF-36 Physical Functioning Score (Yes/No)

Time frame:At week 44

SF-36 physical

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	69	—
	168	—
Placebo	27	—
	89	—

Secondary/registry result

Number of Participants Who Achieved Responder Definition Value For IWQoL-Lite for CT Physical Function (5-items) Score (Yes/No)

Time frame:At week 44

IWQOL-Lite physical

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	83	—
	153	—
Placebo	22	—
	93	—

Secondary/protocol endpoint

Change From Baseline in Short Form-36 (SF-36) - Physical Functioning Score

Time frame:Baseline (week 0), week 44

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Impact of Weight on Quality of Life-Lite for Clinical Trials (IWQOL-Lite for CT) - Physical Function Domain (5-items) Score

Time frame:Baseline (week 0), week 44

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in SF-36 All Domains (Except Physical Functioning) and 2 Component Summary Scores

Time frame:Baseline (week 0), week 44

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in IWQOL-Lite for Physical Domain Score, Psychological Domain Score and Total Score

Time frame:Baseline (week 0), week 44

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved Responder Definition Value for SF-36 Physical Functioning Score (Yes/No)

Time frame:At week 44

SF-36 physical

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved Responder Definition Value For IWQoL-Lite for CT Physical Function (5-items) Score (Yes/No)

Time frame:At week 44

IWQOL-Lite physical

threshold achievement, improvement

Safety / tolerability / PK

18 endpoints

Secondary/registry result

Change From Baseline in Number of Participants With Lipid-Lowering Medication (Decrease, No Change, Increase)

Time frame:Baseline (week 0), week 44

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mgDecreased	3	—
No change	31	—
Increased	1	—
PlaceboDecreased	1	—
No change	13	—
Increased	4	—

Secondary/registry result

Number of Participants Who From Randomization Permanently Discontinued Randomized Trial Product

Time frame:Baseline (week 0), week 44

Discontinuation due to AE

event count, event

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	18	—
Placebo	16	—

Secondary/registry result

Time to Permanent Discontinuation of Randomized Trial Product (Weeks)

Time frame:Baseline (week 0), week 44

Discontinuation due to AE

time to event, event

Posted result

Group	Value (median), Weeks	95% CI
Semaglutide 2.4 mg	16.7	5.4 – 43.1
Placebo	18.8	3.0 – 43.3

Secondary/registry result

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:Baseline (week 0), week 51

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide 2.4 mg	1122	—
Placebo	415	—

Secondary/registry result

Number of Serious Adverse Events (SAEs)

Time frame:Baseline (week 0), week 51

Serious AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide 2.4 mg	14	—
Placebo	8	—

Secondary/registry result

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes (Yes/No) in Participants With T2D at Week 0

Time frame:Baseline (week 0), week 51

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Posted result

Group	Value (number), Episodes	95% CI
Semaglutide 2.4 mg	2	—
Placebo	1	—

Secondary/registry result

Change From Baseline in Amylase: Ratio to Baseline

Time frame:Baseline (week 0), week 44

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of amylase	95% CI
Semaglutide 2.4 mg	1.19	—
Placebo	1.08	—

Secondary/registry result

Change From Baseline in Lipase: Ratio to Baseline

Time frame:Baseline (week 0), week 44

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of lipase	95% CI
Semaglutide 2.4 mg	1.54	—
Placebo	1.08	—

Secondary/registry result

Change From Baseline in Calcitonin: Ratio to Baseline

Time frame:Baseline (week 0), week 44

Thyroid event

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of calcitonin	95% CI
Semaglutide 2.4 mg	1.04	—
Placebo	0.92	—

Secondary/protocol endpoint

Change From Baseline in Number of Participants With Concomitant Oral Antidiabetic Medication (Decrease, No Change, Increase) in Participants With No T2D at Baseline

Time frame:Baseline (week 0), week 44

categorical status, descriptive

Secondary/protocol endpoint

Number of Participants Who From Randomization Permanently Discontinued Randomized Trial Product

Time frame:Baseline (week 0), week 44

Discontinuation due to AE

event count, event

Secondary/protocol endpoint

Time to Permanent Discontinuation of Randomized Trial Product (Weeks)

Time frame:Baseline (week 0), week 44

Discontinuation due to AE

time to event, event

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:Baseline (week 0), week 51

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Events (SAEs)

Time frame:Baseline (week 0), week 51

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes (Yes/No) in Participants With T2D at Week 0

Time frame:Baseline (week 0), week 51

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Change From Baseline in Amylase: Ratio to Baseline

Time frame:Baseline (week 0), week 44

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline in Lipase: Ratio to Baseline

Time frame:Baseline (week 0), week 44

ratio, descriptive

Secondary/protocol endpoint

Change From Baseline in Calcitonin: Ratio to Baseline

Time frame:Baseline (week 0), week 44

Thyroid event

ratio, event

Other (unclassified)

1 endpoint

Secondary/registry result/low confidence

Change From Baseline in Number of Participants With Concomitant Oral Antidiabetic Medication (Decrease, No Change, Increase) in Participants With No T2D at Baseline

Time frame:Baseline (week 0), week 44

categorical status, descriptive

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mgDecreased	16	—
No change	35	—
Increased	1	—
PlaceboDecreased	2	—
No change	16	—
Increased	6	—

Publications (2)

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 once-weekly semaglutide 2.4 mg for weight management in participants from China: A prespecified analysis of the STEP 7 randomized clinical trial.
Diabetes, obesity & metabolism2025 May (month)PMID40069849doi:10.1111/dom.16253via pubmed nct search
Efficacy and safety of once weekly semaglutide 2·4 mg for weight management in a predominantly east Asian population with overweight or obesity (STEP 7): a double-blind, multicentre, randomised controlled trial.
The lancet. Diabetes & endocrinology2024 Mar (month)PMID38330988doi:10.1016/S2213-8587(23)00388-1via CT.gov reference + 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.