A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CagriSema (Cagrilintide B + semaglutide I), Low Energy Diet.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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 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.
Primary outcome measures
- Change in sleeping metabolic rate (SMR) [Time frame: Baseline (Week 0) to Week 20]
Secondary outcome measures (3)
- Change in 24-hour energy expenditure [Time frame: Baseline (Week 0) to Week 20]
- Change in resting metabolic rate (RMR) [Time frame: Baseline (Week 0) to Week 20]
- Change in basal metabolic rate (BMR) [Time frame: Baseline (Week 0) to Week 20]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- Advent Health-Res Inst — Orlando
- Pennington Biomed Res Ctr — Baton Rouge
Identifiers
NCT: NCT07184086 · NN9838-8215 · U1111-1316-8299