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STEP12

CompletedPhase 3Results posted

A Research Study to See How Well Semaglutide Helps People Who Have a Body Weight Above the Healthy Weight Range

Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Adults With Overweight and Obesity

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

242

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI ≥24•HbA1c ≤10%

Primary endpoints

•Body Weight (%)•Body Weight Reduction Greater Than or Equal to (≥) 5% (Yes/No)•Body weight, % 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 IDNCT06041217

Org study IDNN9536-4706

Secondary IDU1111-1273-4538World Health Organization (WHO)

Timeline

Milestones

Study start2023-09-15actual

Study first posted2023-09-18actual

Primary completion2025-04-02actual

Study completion2025-05-07actual

Last update posted2026-05-18actual

Results first posted2026-05-18actual

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

•Age greater than or equal to 18 years at the time of signing informed consent.

•Body mass index (BMI) of greater than or equal to 24 and less than 28 kilogram per square meter ( kg/m^2) with the presence of at least one weight related complication (treated or untreated): Type 2 diabetes (T2D), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease or BMI greater than or equal to 28 and less 30 kg/m^2, with or without weight related complications at screening.

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

For participants with T2D at screening:

- Diagnosed with T2D greater than or equal to 180 days prior to the day of screening

Treated with either:

•Diet and exercise alone or with 1-3 marketed oral antidiabetic drugs (metformin, alpha glucosidase, Sulfonylureas (SU), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i) or glitazone as a single agent or in combination) according to local label.

•Treatment with oral anti-diabetic drugs should be stable (same drug(s) or active ingredient, dose, and dosing frequency) for at least 60 days before screening

•Glycated haemoglobin (HbA1c) of less than or equal to 10.0 percent (less than or equal to 86 millimoles per mol [mmol/mol]) as measured by the central laboratory at screening.

Exclusion criteria

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

•Treatment with any medication for the indication of obesity within the past 90 days before screening.

•Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

For participants without T2D at screening:

- HbA1c greater than or equal to 6.5percent (48 mmol/mol) as measured by the laboratory.

For participants with T2D at screening:

•Renal impairment with estimated Glomerular Filtration Rate (eGFR) value of less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification 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 (48)

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

Safety / tolerability / PK

Weight & body composition

14 endpoints

Primary/registry result

Change in Body Weight (%)

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (mean), Percentage change in body weight	95% CI
Semaglutide 2.4 mg	-12.2	—
Placebo	-2.2	—

Treatment difference-9.8795% CI-11.78 – -7.96p<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 end of treatment (week 44)

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	128	—
	31	—
Placebo	19	—
	59	—

Odds Ratio (OR)14.8395% CI7.42 – 29.63p<0.0001Regression, Logistic

Treatment policy Estimand

Primary/protocol endpoint

Change in Body Weight (%)

Time frame:Baseline (week 0), end of treatment (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 end of treatment (week 44)

≥5% weight-loss responders

threshold achievement, improvement

Secondary/registry result

Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)

Time frame:At end of treatment (week 44)

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	96	—
	63	—
Placebo	9	—
	69	—

Secondary/registry result

Change in Waist Circumference

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (mean), Centimeter (cm)	95% CI
Semaglutide 2.4 mg	-9.1	—
Placebo	-2.4	—

Secondary/registry result

Change in Body Weight (kg)

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (mean), Kg	95% CI
Semaglutide 2.4 mg	-9.3	—
Placebo	-1.7	—

Secondary/registry result

Change in Body Mass Index

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (mean), Kilogram per square meter (kg/m^2)	95% CI
Semaglutide 2.4 mg	-3.4	—
Placebo	-0.6	—

Secondary/registry result

Change in Waist-height Ratio (WtHR)

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (mean), Ratio of waist-height	95% CI
Semaglutide 2.4 mg	-0.05	—
Placebo	-0.01	—

Secondary/protocol endpoint

Number of Participants Who Achieved Body Weight Reduction ≥ 10% (Yes/No)

Time frame:At end of treatment (week 44)

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:Baseline (week 0), end of treatment (week 44)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight (kg)

Time frame:Baseline (week 0), end of treatment (week 44)

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Mass Index

Time frame:Baseline (week 0), end of treatment (week 44)

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Waist-height Ratio (WtHR)

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Glycemic / diabetes

9 endpoints

Secondary/registry result

Change in HbA1c (%)

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Semaglutide 2.4 mg	-0.4	—
Placebo	0.0	—

Secondary/registry result

Change in HbA1c (mmol/Mol)

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (mean), mmol/mol	95% CI
Semaglutide 2.4 mg	-4.2	—
Placebo	0.5	—

Secondary/registry result

Change in Fasting Plasma Glucose (mg/dL)

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (mean), mg/dL	95% CI
Semaglutide 2.4 mg	-12.3	—
Placebo	0.5	—

Secondary/registry result

Change in Fasting Plasma Glucose (mmol/L)

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (mean), mmol/L	95% CI
Semaglutide 2.4 mg	-0.7	—
Placebo	0.0	—

Secondary/registry result

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) Less Than (<) 3.0 mmol/L Confirmed by Blood Glucose (BG) Meter - Participants With Type 2 Diabetes (T2D)

Time frame:From baseline (week 0) to end of study (week 49)

event count, event

Posted result

Group	Value (number), Episodes	95% CI
Semaglutide 2.4 mg	1	—
Placebo	0	—

Secondary/protocol endpoint

Change in HbA1c (%)

Time frame:Baseline (week 0), end of treatment (week 44)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c (mmol/Mol)

Time frame:Baseline (week 0), end of treatment (week 44)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (mg/dL)

Time frame:Baseline (week 0), end of treatment (week 44)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (mmol/L)

Time frame:Baseline (week 0), end of treatment (week 44)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

20 endpoints

Secondary/registry result

Change in Systolic Blood Pressure

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (mean), Millimeter of mercury (mmHg)	95% CI
Semaglutide 2.4 mg	-7	—
Placebo	-4	—

Secondary/registry result

Change in Diastolic Blood Pressure

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (mean), mmHg	95% CI
Semaglutide 2.4 mg	-4	—
Placebo	-2	—

Secondary/registry result

Change in Total Cholesterol (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (geometric_mean), Ratio of total cholesterol	95% CI
Semaglutide 2.4 mg	0.94	—
Placebo	1.01	—

Secondary/registry result

Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

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

Secondary/registry result

Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (geometric_mean), Ratio of LDL	95% CI
Semaglutide 2.4 mg	0.97	—
Placebo	1.02	—

Secondary/registry result

Change in Very Low-Density Lipoproteins (VLDL) Cholesterol (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (geometric_mean), Ratio of VLDL	95% CI
Semaglutide 2.4 mg	0.72	—
Placebo	0.93	—

Secondary/registry result

Change in Triglycerides (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Semaglutide 2.4 mg	0.71	—
Placebo	0.91	—

Secondary/registry result

Change in Free Fatty Acids (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (geometric_mean), Ratio of free fatty acids	95% CI
Semaglutide 2.4 mg	0.88	—
Placebo	0.99	—

Secondary/registry result

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

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (geometric_mean), Ratio of hsCRP	95% CI
Semaglutide 2.4 mg	0.69	—
Placebo	0.68	—

Secondary/registry result

Change in Pulse

Time frame:Baseline (week 0), end of treatment (week 44)

change from baseline, improvement

Posted result

Group	Value (mean), Beats per minute (Beats/min)	95% CI
Semaglutide 2.4 mg	3	—
Placebo	1	—

Secondary/protocol endpoint

Change in Systolic Blood Pressure

Time frame:Baseline (week 0), end of treatment (week 44)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Diastolic Blood Pressure

Time frame:Baseline (week 0), end of treatment (week 44)

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change in Total Cholesterol (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 44)

Total cholesterol, change

ratio, improvement

LOINC 2093-3

Secondary/protocol endpoint

Change in High Density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 44)

HDL-C, change

ratio, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change in Low Density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 44)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

Change in Very Low-Density Lipoproteins (VLDL) Cholesterol (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 44)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Triglycerides (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 44)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change in Free Fatty Acids (mmol/L) - Ratio to Baseline

Time frame:Baseline (week 0), end of treatment (week 44)

Free fatty acids, change

ratio, improvement

Secondary/protocol endpoint

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

Time frame:Baseline (week 0), end of treatment (week 44)

hs-CRP, change

ratio, improvement

LOINC 30522-7

Secondary/protocol endpoint

Change in Pulse

Time frame:Baseline (week 0), end of treatment (week 44)

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

5 endpoints

Secondary/registry result

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to end of study (week 49)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide 2.4 mg	614	—
Placebo	183	—

Secondary/registry result

Number of Serious Adverse Events (SAEs)

Time frame:From baseline (week 0) to end of study (week 49)

event count, event

Posted result

Group	Value (number), Events	95% CI
Semaglutide 2.4 mg	14	—
Placebo	3	—

Secondary/protocol endpoint

Number of Treatment Emergent Adverse Events (TEAEs)

Time frame:From baseline (week 0) to end of study (week 49)

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Serious Adverse Events (SAEs)

Time frame:From baseline (week 0) to end of study (week 49)

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) Less Than (<) 3.0 mmol/L Confirmed by Blood Glucose (BG) Meter - Participants With Type 2 Diabetes (T2D)

Time frame:From baseline (week 0) to end of study (week 49)

Documented hypoglycemia

event count, event

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.