Status:
RECRUITING
A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 medic...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 12 2027
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07184086
Start Date
September 26 2025
End Date
October 12 2027
Last Update
October 8 2025
Active Locations (2)
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1
Advent Health-Res Inst
Orlando, Florida, United States, 32804
2
Pennington Biomed Res Ctr
Baton Rouge, Louisiana, United States, 70808-4124