DRUG
CagriSema (Cagrilintide B + semaglutide I)
Cagrilintide and semaglutide will be administered subcutaneously.
Status
Recruiting
Phase
Phase 1
Enrollment
80
Locations
2
Results
Not posted
Publications
0
Study 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 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.
Interventions
DRUG
Cagrilintide and semaglutide will be administered subcutaneously.
BEHAVIORAL
Participants will receive dietary intervention as per diet intervention manual.
Timeline
First posted
Sep 19, 2025
Study start
Sep 26, 2025
Primary completion
Oct 12, 2027
Study completion
Oct 12, 2027
Results posted
Not reported
Registry updated
Oct 8, 2025
Outcomes
Change in sleeping metabolic rate (SMR)
Time frame · Baseline (Week 0) to Week 20
Measured as kilojoules (kJ) per day.
Change in 24-hour energy expenditure
Time frame · Baseline (Week 0) to Week 20
Measured as kJ per day.
Change in resting metabolic rate (RMR)
Time frame · Baseline (Week 0) to Week 20
Measured as kJ per day.
Change in basal metabolic rate (BMR)
Time frame · Baseline (Week 0) to Week 20
Measured as kJ per day.
Eligibility
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 locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Advent Health-Res Inst
Orlando, Florida, United States
Pennington Biomed Res Ctr
Baton Rouge, Louisiana, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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