CompletedPhase 2Results posted

A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight

Investigation of Once-weekly Semaglutide S.C. Dose-Response in Patients With Type 2 Diabetes and Overweight - a Participant- and Investigator-blinded and Sponsor Open-label Study

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

130

Recruiting sites

Actual enrollment

245

Study population

Obesity / overweight, Type 2 diabetes

Eligibility highlights

•BMI ≥27•HbA1c 7-10.5%

Primary endpoint

•HbA1c, change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05486065

Org study IDNN9535-4984

Secondary ID2022-000882-41

Secondary IDU1111-1271-9209World Health Organization (WHO)

Timeline

Milestones

Study first posted2022-08-03actual

Study start2022-08-08actual

Primary completion2023-10-12actual

Study completion2023-12-13actual

Results first posted2024-11-05actual

Last update posted2025-12-12actual

Assets

Investigational agents

Semaglutide

Who this study enrolls

Obesity / overweightType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age64 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female.

•Aged 18-64 years (both inclusive) at the time of signing informed consent.

•Diagnosed with type 2 diabetes mellitus greater than equal to (≥) 180 days prior to the day of screening.

•Glycosylated haemoglobin (HbA1c) of 7.0 - 10.5 percentage (%) [53 - 91 millimoles per mole (mmol/mol)] (both inclusive).

•Body Mass Index (BMI) ≥ 27.0 kilograms per meter square (kg/m^2).

•Stable daily dose(s) ≥ 90 days prior to the day of screening of any metformin formulations.

Exclusion criteria

•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.

•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of 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.

•Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than (<) 30 milliliters per minute (mL/min)/1.73 meter square (m^2) at screening.

Endpoints (8)

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

Safety / tolerability / PK

Weight & body composition

Glycemic / diabetes

Weight & body composition

2 endpoints

Secondary/registry result

Change in Body Weight

Time frame:Baseline (week 0) and End of treatment (week 40)

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

Group	Mean · Kilogram (kg)	95% CI
Semaglutide 2.0 mg	-8.9	-
Semaglutide 8.0 mg	-10.1	-
Semaglutide 16.0 mg	-13.1	-
Placebo	-2.3	-

Secondary/protocol endpoint

Change in Body Weight

Time frame:Baseline (week 0) and End of treatment (week 40)

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Primary/registry result

Change in Glycated Haemoglobin (HbA1c)

Time frame:Baseline (week 0) and End of treatment (week 40)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

Group	Mean · Percentage-point of HbA1c	95% CI
Semaglutide 2.0 mg	-1.9	-
Semaglutide 8.0 mg	-1.8	-
Semaglutide 16.0 mg	-2.1	-
Placebo	-1.1	-

Treatment difference-0.8295% CI-1.25 - -0.39p0.0002ANCOVA

Treatment difference-0.7795% CI-1.19 - -0.35p0.0003ANCOVA

Treatment difference-1.0795% CI-1.50 - -0.64p<.0001ANCOVA

Treatment difference0.0595% CI-0.38 - 0.47p0.8305ANCOVA

Treatment difference-0.3095% CI-0.72 - 0.13p0.1678ANCOVA

Treatment difference-0.2595% CI-0.67 - 0.17p0.2445ANCOVA

Primary/protocol endpoint

Change in Glycated Haemoglobin (HbA1c)

Time frame:Baseline (week 0) and End of treatment (week 40)

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

4 endpoints

Secondary/registry result

Number of Treatment-emergent Adverse Events (TEAEs)

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

Treatment-emergent AEs (any)

event count, event

Posted result

Group	Number · Events	95% CI
Semaglutide 2.0 mg	43	-
Semaglutide 8.0 mg	54	-
Semaglutide 16.0 mg	55	-
Placebo	37	-

Secondary/registry result

Number of Treatment-emergent Severe Hypoglycaemic Episodes

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

Severe hypoglycemia

event count, event

Posted result

Group	Number · Episodes	95% CI
Semaglutide 2.0 mg	0	-
Semaglutide 8.0 mg	0	-
Semaglutide 16.0 mg	0	-
Placebo	0	-

Secondary/protocol endpoint

Number of Treatment-emergent Adverse Events (TEAEs)

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

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Treatment-emergent Severe Hypoglycaemic Episodes

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

Severe hypoglycemia

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.