RecruitingPhase 1

A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet

The Effect of Cagrilintide and Semaglutide Combination Treatment Compared to a Weight-loss Inducing Diet on Energy Metabolism in Persons Living With Obesity: an Open-label Randomised Study

Lead sponsor

Novo Nordisk A/S

Assets

CagriSema / cagrilintide / Semaglutide

Listed sites

Recruiting sites

Estimated enrollment

Study population

Obesity / overweight

Eligibility highlights

Primary endpoint

•Sleeping metabolic rate (SMR)

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 IDNCT07184086

Org study IDNN9838-8215

Secondary IDU1111-1316-8299World Health Organization (WHO)

Timeline

Milestones

Study first posted2025-09-19actual

Study start2025-09-26actual

Last update posted2025-10-08actual

Primary completion2027-10-12estimated

Study completion2027-10-12estimated

Assets

Investigational agents

CagriSema / cagrilintide Semaglutide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age65 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female (sex assigned at birth).

•Age 18-65 years (both inclusive) at the time of signing the informed consent.

•Body Mass Index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m^2) at screening (Visit 1). Excess body weight should be due to excess adipose tissue, as judged by the investigator.

Exclusion criteria

•Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.

•History of diabetes mellitus of any type, other than gestational diabetes mellitus.

•Claustrophobia or severe discomfort of being confined in small rooms.

•Contraindication for magnetic resonance imaging (MRI) scanning as per local guidance, including physical limitations that prevent the MRI scan.

•Unusual meal habits (including, but not limited to, eating disorders) and special diet requirements or unwillingness to eat the food provided in the study.

•Treatment with metformin or other glucose-lowering agent(s) within 90 days before screening (V1), regardless of indication.

•Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening (Visit 1).

•Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia) within 5 years before screening (Visit 1).

•Physical measurement exceeding the dimensions or load capacity of the magnetic resonance imaging (MRI)/dual-energy X-ray absorptiometry (DEXA) scanner.

Endpoints (4)

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

Other (unclassified)

Weight & body composition

1 endpoint

Secondary/protocol endpoint/low confidence

Change in basal metabolic rate (BMR)

Time frame:Baseline (Week 0) to Week 20

change from baseline, descriptive

Other (unclassified)

3 endpoints

Primary/protocol endpoint/low confidence

Change in sleeping metabolic rate (SMR)

Time frame:Baseline (Week 0) to Week 20

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in 24-hour energy expenditure

Time frame:Baseline (Week 0) to Week 20

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change in resting metabolic rate (RMR)

Time frame:Baseline (Week 0) to Week 20

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

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.