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STEP 10

CompletedPhase 3Results posted

Research Study Looking at How Well Semaglutide Works in People Living With Obesity and Prediabetes

Efficacy and Safety of Subcutaneous Semaglutide 2.4 mg Once-weekly in Subjects With Obesity and Prediabetes

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

207

actual

Study population

Obesity / overweight, Prediabetes / glucose intolerance

Key I/E criteria

•BMI ≥30•HbA1c 6-6.4%

Primary endpoints

•Body weight, % change•Participants With Change to Normoglycemia

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 IDNCT05040971

Org study IDNN9536-4734

Secondary ID2020-002939-29

Secondary IDU1111-1253-1956World Health Organization (WHO)

Timeline

Milestones

Study start2021-09-06actual

Study first posted2021-09-10actual

Primary completion2023-01-06actual

Study completion2023-07-14actual

Results first posted2024-10-28actual

Last update posted2026-01-29actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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

•BMI greater than or equal to 30.0 kg/m^2

•Prediabetes defined as at least one of the following:

–HbA1c between 6.0 and 6.4 percent (42 and 47 mmol/mol) (both inclusive) as measured by central laboratory at screening.

–FPG between 5.5 and 6.9 mmol/L (99 and 125 mg/dL) (both inclusive) as measured by central laboratory at screening.

Exclusion criteria

•History of type 1 or type 2 diabetes.

•Treatment with glucose-lowering agent(s) within 90 days before screening.

•HbA1c greater than or equal to 6.5 percent (greater than or equal to 48 mmol/mol) as measured by central laboratory at screening.

•FPG greater than or equal to 7.0mmol/L (126 mg/dL) as measured by central laboratory at screening.

A self-reported change in body weight greater than 5 kg (11 lbs) 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.

Endpoints (34)

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

Glycemic / diabetes

Weight & body composition

14 endpoints

Primary/registry result

Change in Body Weight (Percentage [%])

Time frame:From randomisation (week 0) to end of treatment (week 52)

Body weight, % change

percent change from baseline, improvement

Posted result

Group	Value (mean), Percentage (%) of body weight	95% CI
Semaglutide 2.4 mg	-14.4	—
Placebo	-2.7	—

Treatment difference-11.1995% CI-12.97 – -9.42p<0.0001ANCOVA

Treatment policy estimand

Primary/protocol endpoint

Change in Body Weight (Percentage [%])

Time frame:From randomisation (week 0) to end of treatment (week 52)

Body weight, % change

percent change from baseline, improvement

Secondary/registry result

Change in Waist Circumference

Time frame:From randomisation (week 0) to end of treatment (week 52)

Waist circumference, change

change from baseline, improvement

Posted result

Group	Value (mean), centimeter (cm)	95% CI
Semaglutide 2.4 mg	-11.6	—
Placebo	-2.8	—

Secondary/registry result

Change in Body Weight (Kilogram [Kg])

Time frame:From randomisation (week 0) to week 52

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Value (mean), kilogram (Kg)	95% CI
Semaglutide 2.4 mg	-15.8	—
Placebo	-2.8	—

Secondary/registry result

Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No)

Time frame:At week 52

≥5% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	111	—
	18	—
Placebo	17	—
	49	—

Secondary/registry result

Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No)

Time frame:At week 52

≥10% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	95	—
	34	—
Placebo	5	—
	61	—

Secondary/registry result

Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No)

Time frame:At week 52

≥15% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	62	—
	67	—
Placebo	1	—
	65	—

Secondary/registry result

Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No)

Time frame:At week 52

≥20% weight-loss responders

threshold achievement, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	32	—
	97	—
Placebo	0	—
	66	—

Secondary/protocol endpoint

Change in Waist Circumference

Time frame:From randomisation (week 0) to end of treatment (week 52)

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change in Body Weight (Kilogram [Kg])

Time frame:From randomisation (week 0) to week 52

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 5% (Yes/No)

Time frame:At week 52

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 10% (Yes/No)

Time frame:At week 52

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 15% (Yes/No)

Time frame:At week 52

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participants Achieving Body Weight Reduction Greater Than or Equal (≥) 20% (Yes/No)

Time frame:At week 52

≥20% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

6 endpoints

Primary/registry result/low confidence

Participants With Change to Normoglycemia

Time frame:At week 52

categorical status, improvement

Posted result

Group	Value (count_of_participants), Participants	95% CI
Semaglutide 2.4 mg	103	—
	23	—
	1	—
Placebo	9	—
	53	—
	2	—

Odds Ratio (OR)19.8195% CI8.68 – 45.21p<0.0001Regression, Logistic

Treatment policy estimand

Primary/protocol endpoint

Participants With Change to Normoglycemia

Time frame:At week 52

categorical status, improvement

Secondary/registry result

Change in Glycosylated Haemoglobin (HbA1c)

Time frame:From randomisation (week 0) to end of treatment (week 52)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Value (mean), Percentage of HbA1c	95% CI
Semaglutide 2.4 mg	-0.4	—
Placebo	0.1	—

Secondary/registry result

Change in Fasting Plasma Glucose (FPG)

Time frame:From randomisation (week 0) to end of treatment (week 52)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Value (mean), millimoles per liter (mmol/L)	95% CI
Semaglutide 2.4 mg	-0.8	—
Placebo	-0.3	—

Secondary/protocol endpoint

Change in Glycosylated Haemoglobin (HbA1c)

Time frame:From randomisation (week 0) to end of treatment (week 52)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in Fasting Plasma Glucose (FPG)

Time frame:From randomisation (week 0) to end of treatment (week 52)

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

14 endpoints

Secondary/registry result

Change in Systolic Blood Pressure

Time frame:From randomisation (week 0) to end of treatment (week 52)

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	-9	—
Placebo	-1	—

Secondary/registry result

Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline

Time frame:From randomisation (week 0) to end of treatment (week 52)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Posted result

Group	Value (geometric_mean), Ratio of triglycerides	95% CI
Semaglutide 2.4 mg	0.80	—
Placebo	0.96	—

Secondary/registry result

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

Time frame:From randomisation (week 0) to end of treatment (week 52)

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	1.01	—

Secondary/registry result

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

Time frame:From randomisation (week 0) to end of treatment (week 52)

HDL-C, change

ratio, improvement

LOINC 2085-9

Posted result

Group	Value (geometric_mean), Ratio of HDL cholesterol	95% CI
Semaglutide 2.4 mg	1.02	—
Placebo	0.99	—

Secondary/registry result

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

Time frame:From randomisation (week 0) to end of treatment (week 52)

LDL-C, change

ratio, improvement

LOINC 13457-7

Posted result

Group	Value (geometric_mean), Ratio of LDL cholesterol	95% CI
Semaglutide 2.4 mg	0.93	—
Placebo	1.03	—

Secondary/registry result

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

Time frame:From randomisation (week 0) to end of treatment (week 52)

VLDL, change

ratio, improvement

Posted result

Group	Value (geometric_mean), Ratio of VLDL cholesterol	95% CI
Semaglutide 2.4 mg	0.80	—
Placebo	0.96	—

Secondary/registry result

Change in Pulse

Time frame:From randomisation (week 0) to end of treatment (week 52)

Heart rate, change

change from baseline, improvement

Posted result

Group	Value (mean), beats per minute (bpm)	95% CI
Semaglutide 2.4 mg	2	—
Placebo	0	—

Secondary/protocol endpoint

Change in Systolic Blood Pressure

Time frame:From randomisation (week 0) to end of treatment (week 52)

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change in Triglycerides (Millimoles Per Liter [mmol/L]) - Ratio to Baseline

Time frame:From randomisation (week 0) to end of treatment (week 52)

Triglycerides, change

ratio, improvement

LOINC 2571-8

Secondary/protocol endpoint

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

Time frame:From randomisation (week 0) to end of treatment (week 52)

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:From randomisation (week 0) to end of treatment (week 52)

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:From randomisation (week 0) to end of treatment (week 52)

LDL-C, change

ratio, improvement

LOINC 13457-7

Secondary/protocol endpoint

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

Time frame:From randomisation (week 0) to end of treatment (week 52)

VLDL, change

ratio, improvement

Secondary/protocol endpoint

Change in Pulse

Time frame:From randomisation (week 0) to end of treatment (week 52)

Heart rate, change

change from baseline, improvement

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Efficacy and safety of once-weekly semaglutide 2·4 mg versus placebo in people with obesity and prediabetes (STEP 10): a randomised, double-blind, placebo-controlled, multicentre phase 3 trial.
The lancet. Diabetes & endocrinology2024 Sep (month)PMID39089293doi:10.1016/S2213-8587(24)00182-7via 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.