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NCT Number: NCT07184086

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

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.

Recruiting

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Advent Health-Res Inst, Orlando, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CagriSema (Cagrilintide B + semaglutide I)

Drug

Cagrilintide and semaglutide will be administered subcutaneously.

Low Energy Diet

Behavioral

Participants will receive dietary intervention as per diet intervention manual.

Primary outcomes

  1. Change in sleeping metabolic rate (SMR)

    Time frame: Baseline (Week 0) to Week 20

    Measured as kilojoules (kJ) per day.

Secondary outcomes

  1. Change in 24-hour energy expenditure

    Time frame: Baseline (Week 0) to Week 20

    Measured as kJ per day.

  2. Change in resting metabolic rate (RMR)

    Time frame: Baseline (Week 0) to Week 20

    Measured as kJ per day.

  3. Change in basal metabolic rate (BMR)

    Time frame: Baseline (Week 0) to Week 20

    Measured as kJ per day.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 19, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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