← Trials/Trial dossier/NCT03811574

STEP 6

CompletedPhase 3Results posted

STEP 6: Research Study Investigating How Well Semaglutide Works in People Living With Overweight or Obesity

Effect and Safety of Semaglutide Once-weekly in East Asian Subjects With Overweight or Obesity

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

401

actual

Study population

Obesity / overweight

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 IDNCT03811574

Org study IDNN9536-4382

Secondary IDU1111-1201-1629World Health Organization (WHO)

Timeline

Milestones

Study start2019-01-21actual

Study first posted2019-01-22actual

Primary completion2020-11-20actual

Study completion2020-11-20actual

Last update posted2022-03-22actual

Results first posted2022-03-22actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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

•BMI more than or equal to 27.0 kg/m^2 with more than or equal to 2 weight related comorbidities (treated or untreated) or BMI more than or equal to 35.0 kg/m^2 with more than or equal to 1 weight related comorbidity (treated or untreated) according to the JASSO guideline. At least one comorbidity should be hypertension or dyslipidaemia (Japan only: or T2D)

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

•For subjects with T2D at screening (Japan only):

a)Diagnosed with T2D more than or equal to 180 days prior to the day of screening.

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

Exclusion criteria

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

•For subjects without T2D at screening: HbA1c more than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening

•For subjects with T2D at screening (Japan only):

a)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 co-transporter 2 inhibitor (SGLT2i)) according to chronic kidney disease epidemiology (CKD-EPI) creatinine equation as defined by kidney disease improving global outcome (KDIGO) 2012 by the central laboratory at screening.

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

Endpoints (78)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Cardiometabolic biomarkers

Safety / tolerability / PK

Glycemic / diabetes

Patient-reported / QoL

Weight & body composition

22 endpoints

Primary/registry result

Change in Body Weight (%)

Time frame:Baseline (week 0), week 68

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Semaglutide 1.7 mg	-9.9	—
Semaglutide 2.4 mg	-13.4	—
Placebo	-1.9	—

Treatment difference-7.5295% CI-9.62 – -5.43p<.0001ANCOVA

Treatment policy estimand

Treatment difference-11.0695% CI-12.88 – -9.24p<.0001ANCOVA

Treatment policy estimand

Primary/registry result

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%

Time frame:At week 68

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 1.7 mg	71	—
	27	—
Semaglutide 2.4 mg	160	—
	33	—
Placebo	21	—
	79	—

Odds Ratio (OR)11.0895% CI5.53 – 22.22p<.0001Regression, Logistic

Treatment policy estimand

Odds Ratio (OR)21.7295% CI11.27 – 41.86p<.0001Regression, Logistic

Treatment policy estimand

Primary/protocol endpoint

Change in Body Weight (%)

Time frame:Baseline (week 0), week 68

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 5%

Time frame:At week 68

≥5% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%

Time frame:At week 68

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 1.7 mgYes	41	—
No	57	—
Semaglutide 2.4 mgYes	117	—
No	76	—
PlaceboYes	5	—
No	95	—

Secondary/registry result

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%

Time frame:At week 68

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 1.7 mgYes	24	—
No	74	—
Semaglutide 2.4 mgYes	79	—
No	114	—
PlaceboYes	3	—
No	97	—

Secondary/registry result

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%

Time frame:At week 68

≥20% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 1.7 mgYes	11	—
No	87	—
Semaglutide 2.4 mgYes	38	—
No	155	—
PlaceboYes	2	—
No	98	—

Secondary/registry result

Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest

Time frame:Baseline (week 0) to week 68

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), Centimeter (cm)	95% CI
Semaglutide 1.7 mg	-7.8	—
Semaglutide 2.4 mg	-11.2	—
Placebo	-1.8	—

Secondary/registry result

Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline

Time frame:Baseline (week 0) to week 68

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), Centimeter (cm)	95% CI
Semaglutide 1.7 mg	-7.6	—
Semaglutide 2.4 mg	-10.2	—
Placebo	-1.9	—

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 1.7 mg	-8.3	—
Semaglutide 2.4 mg	-11.3	—
Placebo	-1.7	—

Secondary/registry result

Change in Body Mass Index (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 1.7 mg	-3.1	—
Semaglutide 2.4 mg	-4.3	—
Placebo	-0.6	—

Secondary/registry result

Change in Visceral Fat Area (VFA) (%)

Time frame:Baseline (week 0) to week 68

Visceral fat, change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage change	95% CI
Semaglutide 1.7 mg	-22.3	—
Semaglutide 2.4 mg	-41.0	—
Placebo	-7.1	—

Secondary/registry result

Change in Visceral Fat Area (VFA) Centimeter Square (cm^2)

Time frame:Baseline (week 0) to week 68

Visceral fat, change

change from baseline, improvement

Posted result

Group	Value (mean), centimeter square (cm^2)	95% CI
Semaglutide 1.7 mg	-41.7	—
Semaglutide 2.4 mg	-67.4	—
Placebo	-13.8	—

Secondary/protocol endpoint

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 10%

Time frame:At week 68

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 15%

Time frame:At week 68

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Who Achieve (Yes/no): Body Weight Reduction More Than or Equal to 20%

Time frame:At week 68

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Waist Circumference Measured Midway Between the Lower Rib Margin and the Iliac Crest

Time frame:Baseline (week 0) to week 68

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist Circumference Measured According to the JASSO (Japan Society for the Study of Obesity) Guideline

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 Body Mass Index (BMI)

Time frame:Baseline (week 0) to week 68

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Visceral Fat Area (VFA) (%)

Time frame:Baseline (week 0) to week 68

Visceral fat, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Visceral Fat Area (VFA) Centimeter Square (cm^2)

Time frame:Baseline (week 0) to week 68

Visceral fat, change

change from baseline, improvement

Glycemic / diabetes

12 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 of HbA1c	95% CI
Semaglutide 1.7 mg	-0.9	—
Semaglutide 2.4 mg	-1.0	—
Placebo	0.0	—

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 1.7 mg	-9.9	—
Semaglutide 2.4 mg	-10.6	—
Placebo	-0.1	—

Secondary/registry result

Change in Fasting Plasma Glucose

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 1.7 mg	-18.3	—
Semaglutide 2.4 mg	-19.3	—
Placebo	1.7	—

Secondary/registry result

Change in Fasting Serum Insulin-ratio to Baseline

Time frame:Baseline (week 0) to week 68

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of fasting serum insulin	95% CI
Semaglutide 1.7 mg	0.85	—
Semaglutide 2.4 mg	0.71	—
Placebo	0.89	—

Secondary/registry result

Number of Participants Who Achieved (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 1.7 mgYes	24	—
No	1	—
Semaglutide 2.4 mgYes	43	—
No	6	—
PlaceboYes	1	—
No	24	—

Secondary/registry result

Number of Participants Who Achieved (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 1.7 mgYes	22	—
No	3	—
Semaglutide 2.4 mgYes	40	—
No	9	—
PlaceboYes	1	—
No	24	—

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 Fasting Plasma Glucose

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-ratio to Baseline

Time frame:Baseline (week 0) to week 68

ratio, improvement

Secondary/protocol endpoint

Number of Participants Who Achieved (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

Number of Participants Who Achieved (Yes/no): HbA1c ≤6.5% (48 mmol/Mol)

Time frame:At week 68

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

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), millimeters of mercury (mmHg)	95% CI
Semaglutide 1.7 mg	-12	—
Semaglutide 2.4 mg	-11	—
Placebo	-5	—

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), mmHg	95% CI
Semaglutide 1.7 mg	-5	—
Semaglutide 2.4 mg	-5	—
Placebo	-3	—

Secondary/registry result

Change in Total Cholesterol-ratio to Baseline

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 1.7 mg	0.93	—
Semaglutide 2.4 mg	0.91	—
Placebo	1.00	—

Secondary/registry result

Change in High-density Lipoproteins (HDL)-Ratio to Baseline

Time frame:Baseline (week 0) to week 68

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of high-density lipoproteins	95% CI
Semaglutide 1.7 mg	1.06	—
Semaglutide 2.4 mg	1.08	—
Placebo	1.06	—

Secondary/registry result

Change in Low-density Lipoproteins (LDL)-Ratio to Baseline

Time frame:Baseline (week 0) to week 68

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of low-density lipoproteins	95% CI
Semaglutide 1.7 mg	0.90	—
Semaglutide 2.4 mg	0.86	—
Placebo	0.95	—

Secondary/registry result

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

Time frame:Baseline (week 0) to week 68

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of very low-density lipoproteins	95% CI
Semaglutide 1.7 mg	0.79	—
Semaglutide 2.4 mg	0.79	—
Placebo	1.05	—

Secondary/registry result

Change in Free Fatty Acids-ratio to Baseline

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 1.7 mg	1.04	—
Semaglutide 2.4 mg	0.96	—
Placebo	1.28	—

Secondary/registry result

Change in Triglycerides-ratio to Baseline

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 1.7 mg	0.78	—
Semaglutide 2.4 mg	0.79	—
Placebo	1.05	—

Secondary/registry result

Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline

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 1.7 mg	0.64	—
Semaglutide 2.4 mg	0.39	—
Placebo	0.92	—

Secondary/registry result

Change in Plasminogen Activator Inhibitor-1 Activity-ratio to Baseline

Time frame:Baseline (week 0) to week 68

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of PAI-1 activity	95% CI
Semaglutide 1.7 mg	0.83	—
Semaglutide 2.4 mg	0.68	—
Placebo	1	—

Secondary/registry result

Change in Pulse

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 1.7 mg	6	—
Semaglutide 2.4 mg	4	—
Placebo	2	—

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-ratio to Baseline

Time frame:Baseline (week 0) to week 68

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in High-density Lipoproteins (HDL)-Ratio to Baseline

Time frame:Baseline (week 0) to week 68

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Low-density Lipoproteins (LDL)-Ratio to Baseline

Time frame:Baseline (week 0) to week 68

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

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

Time frame:Baseline (week 0) to week 68

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Free Fatty Acids-ratio to Baseline

Time frame:Baseline (week 0) to week 68

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

Change in Triglycerides-ratio to Baseline

Time frame:Baseline (week 0) to week 68

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in High Sensitivity C-reactive Protein (hsCRP)-Ratio to Baseline

Time frame:Baseline (week 0) to week 68

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in Plasminogen Activator Inhibitor-1 Activity-ratio to Baseline

Time frame:Baseline (week 0) to week 68

ratio, improvement

Secondary/protocol endpoint

Change in Pulse

Time frame:Baseline (week 0) to week 68

Heart rate, change

change from baseline, improvement

Patient-reported / QoL

8 endpoints

Secondary/registry result

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

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 1.7 mgChange in SF-36:Physical functioning score	0.0	—
Change in SF-36: Role-Physical score	-1.6	—
Change in SF-36: Bodily Pain score	-1.8	—
Change in SF-36: General Health score	-1.4	—
Change in SF-36: Vitality score	-2.4	—
Change in SF-36: Social Functioning score	-0.8	—
Change in SF-36: Role-Emotional score	-1.6	—
Change in SF-36: Mental Health score	-1.9	—
Change in SF-36: Physical component summary	-0.8	—
Change in SF-36: Mental component summary	-2.0	—
Semaglutide 2.4 mgChange in SF-36:Physical functioning score	1.0	—
Change in SF-36: Role-Physical score	-0.2	—
Change in SF-36: Bodily Pain score	-1.1	—
Change in SF-36: General Health score	0.4	—
Change in SF-36: Vitality score	-1.5	—
Change in SF-36: Social Functioning score	-0.9	—
Change in SF-36: Role-Emotional score	-1.1	—
Change in SF-36: Mental Health score	-1.5	—
Change in SF-36: Physical component summary	0.7	—
Change in SF-36: Mental component summary	-1.9	—
PlaceboChange in SF-36:Physical functioning score	-0.5	—
Change in SF-36: Role-Physical score	0.3	—
Change in SF-36: Bodily Pain score	-0.2	—
Change in SF-36: General Health score	-0.6	—
Change in SF-36: Vitality score	-0.9	—
Change in SF-36: Social Functioning score	0.3	—
Change in SF-36: Role-Emotional score	-0.9	—
Change in SF-36: Mental Health score	-1.2	—
Change in SF-36: Physical component summary	0.1	—
Change in SF-36: Mental component summary	-1.0	—

Secondary/registry result

Change in Impact of Weight on Quality of Life-lite for Clinical Trials (IWQOL-Lite for CT) 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 1.7 mgPhysical function score	2.6	—
Physical	1.9	—
Psychosocial	4.4	—
Total	3.5	—
Semaglutide 2.4 mgPhysical function score	4.9	—
Physical	4.2	—
Psychosocial	5.2	—
Total	4.8	—
PlaceboPhysical function score	0.5	—
Physical	-0.8	—
Psychosocial	-0.3	—
Total	-0.5	—

Secondary/registry result

Number of 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 1.7 mgYes	19	—
No	79	—
Semaglutide 2.4 mgYes	43	—
No	149	—
PlaceboYes	13	—
No	87	—

Secondary/registry result

Number of Participants Who Achieve (Yes/no): Responder Definition Value for IWQoL-Lite for CT Physical Function (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 1.7 mgYes	19	—
No	79	—
Semaglutide 2.4 mgYes	49	—
No	143	—
PlaceboYes	11	—
No	89	—

Secondary/protocol endpoint

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

Time frame:Baseline (week 0) to week 68

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change in Impact of Weight on Quality of Life-lite for Clinical Trials (IWQOL-Lite for CT) Score

Time frame:Baseline (week 0) to week 68

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Number of 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

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

Time frame:At week 68

IWQOL-Lite physical

threshold achievement, improvement

Safety / tolerability / PK

14 endpoints

Secondary/registry result

Number of Treatment-emergent AEs

Time frame:Week 0 to week 75

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide 1.7 mg	483	—
Semaglutide 2.4 mg	834	—
Placebo	235	—

Secondary/registry result

Number of Serious Adverse Events

Time frame:Week 0 to week 75

Serious AEs (any)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide 1.7 mg	10	—
Semaglutide 2.4 mg	12	—
Placebo	7	—

Secondary/registry result

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes

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 1.7 mg	0	—
Semaglutide 2.4 mg	0	—
Placebo	0	—

Secondary/registry result

Change in Amylase: Ratio to Baseline

Time frame:Baseline (week 0) to week 68

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of amylase	95% CI
Semaglutide 1.7 mg	1.09	—
Semaglutide 2.4 mg	1.08	—
Placebo	0.93	—

Secondary/registry result

Change in Lipase: Ratio to Baseline

Time frame:Baseline (week 0) to week 68

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of lipase	95% CI
Semaglutide 1.7 mg	1.56	—
Semaglutide 2.4 mg	1.56	—
Placebo	0.96	—

Secondary/registry result

Change in Calcitonin: Ratio to Baseline

Time frame:Baseline (week 0) to week 68

Thyroid event

ratio, descriptive

Posted result

Group	Value (geometric_mean), Ratio of calcitonin	95% CI
Semaglutide 1.7 mg	0.98	—
Semaglutide 2.4 mg	0.95	—
Placebo	0.94	—

Secondary/registry result

Change in QTCF Interval

Time frame:Baseline (week 0) to week 68

change from baseline, descriptive

Posted result

Group	Value (mean), millisecond (msec)	95% CI
Semaglutide 1.7 mg	-2.2	—
Semaglutide 2.4 mg	-2.5	—
Placebo	5.6	—

Secondary/protocol endpoint

Number of Treatment-emergent AEs

Time frame:Week 0 to week 75

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Events

Time frame:Week 0 to week 75

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemia Episodes

Time frame:Week 0 to week 75

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Change in Amylase: Ratio to Baseline

Time frame:Baseline (week 0) to week 68

ratio, descriptive

Secondary/protocol endpoint

Change in Lipase: Ratio to Baseline

Time frame:Baseline (week 0) to week 68

ratio, descriptive

Secondary/protocol endpoint

Change in Calcitonin: Ratio to Baseline

Time frame:Baseline (week 0) to week 68

Thyroid event

ratio, event

Secondary/protocol endpoint

Change in QTCF Interval

Time frame:Baseline (week 0) to week 68

change from baseline, descriptive

Publications (3)

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

Effect of once-weekly subcutaneous semaglutide on abdominal visceral fat area in Japanese adults with overweight and obesity: A post hoc analysis of the STEP 6 trial.
Obesity research & clinical practice2025 Mar-Apr (year)PMID40189961doi:10.1016/j.orcp.2025.03.003via clinicaltrials gov reference derived + pubmed nct search
Semaglutide once a week in adults with overweight or obesity, with or without type 2 diabetes in an east Asian population (STEP 6): a randomised, double-blind, double-dummy, placebo-controlled, phase 3a trial.
The lancet. Diabetes & endocrinology2022 Mar (month)PMID35131037doi:10.1016/S2213-8587(22)00008-0via clinicaltrials gov reference derived + 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

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.