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

October 7, 2025 updated by: Novo Nordisk A/S

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

In this study we will be looking into how CagriSema influences metabolism (the process by which food is used to supply energy for the body) compared to a diet. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors but has previously been tested in humans. The study is split into 2 parts. In the first part of the study, participants will either get CagriSema or a weight loss diet (calorie reduced). In the second part of the study,all participants will get CagriSema. Which treatment participants get in the first part of the study is decided by chance. Like all medicines, the study medicine may have side effects. The study will last for about 1.5 years.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Recruiting
        • Advent Health-Res Inst
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808-4124
        • Recruiting
        • Pennington Biomed Res Ctr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CagriSema (Cagrilintide + Semaglutide) / CagriSema
Participants will receive subcutaneous (s.c.) dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen in Period A for up to 20 weeks and continue to receive the same dose escalation regimen until maximum dose is reached in Period B for up to 52 weeks.
Drug: CagriSema (Cagrilintide B + semaglutide I)
Cagrilintide and semaglutide will be administered subcutaneously.
Experimental: Low Energy Diet (LED) / CagriSema
Participants will receive a dietary intervention in period A for up to 20 weeks followed by a s.c. dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen until maximum dose is reached in Period B for up to 52 weeks.
Drug: CagriSema (Cagrilintide B + semaglutide I)
Cagrilintide and semaglutide will be administered subcutaneously.
Behavioral: Low Energy Diet
Participants will receive dietary intervention as per diet intervention manual.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sleeping metabolic rate (SMR)
Time Frame: Baseline (Week 0) to Week 20
Measured as kilojoules (kJ) per day.
Baseline (Week 0) to Week 20

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in 24-hour energy expenditure
Time Frame: Baseline (Week 0) to Week 20
Measured as kJ per day.
Baseline (Week 0) to Week 20
Change in resting metabolic rate (RMR)
Time Frame: Baseline (Week 0) to Week 20
Measured as kJ per day.
Baseline (Week 0) to Week 20
Change in basal metabolic rate (BMR)
Time Frame: Baseline (Week 0) to Week 20
Measured as kJ per day.
Baseline (Week 0) to Week 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2025

Primary Completion (Estimated)

October 12, 2027

Study Completion (Estimated)

October 12, 2027

Study Registration Dates

First Submitted

September 13, 2025

First Submitted That Met QC Criteria

September 13, 2025

First Posted (Estimated)

September 19, 2025

Study Record Updates

Last Update Posted (Estimated)

October 8, 2025

Last Update Submitted That Met QC Criteria

October 7, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN9838-8215
  • U1111-1316-8299 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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