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A Study on Cagrilintide and Semaglutide for Obesity

This study is looking at how a new investigational medicine called CagriSema (a combination of Cagrilintide and semaglutide) affects your body's metabolism (how your body uses food for energy) compared to a low-calorie diet. CagriSema has been tested in people before but isn't available by prescription yet. You could join if you are between 18 and 65 years old, have a Body Mass Index (BMI) of 30 or higher, and your extra weight is due to excess body fat. The main goal is to see how much your sleeping metabolic rate changes from the start of the study to Week 20. The study is currently unclear on its recruitment status and plans to enroll 80 participants.

Study design
This interventional study involves 80 participants and is split into two parts. In the first part, participants will randomly receive either CagriSema or a low-energy diet.
What's involved
The study will last for about 1.5 years. Your sleeping metabolic rate will be measured at the beginning and again at Week 20.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring changes in sleeping metabolic rate is at Week 20.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07184086

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

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Novo Nordisk A/S
~80 participants
Updated 2025-10-08 on ClinicalTrials.gov
What's tested:CagriSema (Cagrilintide B + semaglutide I)Low Energy Diet

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in sleeping metabolic rate (SMR)
Measured over Baseline (Week 0) to Week 20

Conditions

Obesity

Explore related trials

Obesity

Where it's being run

2 sites across 2 states
Florida1
Louisiana1

Study leadership

  • Clinical Transparency (dept. 2834) · STUDY_DIRECTOR · Novo Nordisk A/S

Who to contact

Novo Nordisk
[email protected]
(+1) 866-867-7178
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change in sleeping metabolic rate (SMR)Baseline (Week 0) to Week 20

    Measured as kilojoules (kJ) per day.