Metabolic effects of weight loss from CagriSema (cagrilintide + semaglutide) versus a calorie-reduced diet
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
This study will test whether the drug combination CagriSema changes metabolism differently than a calorie-reduced diet in adults with obesity.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Novo Nordisk A/S Industry-sponsored |
| Locations | 2 sites (Orlando, Florida and 1 other locations) |
| Trial ID | NCT07184086 on ClinicalTrials.gov |
What this trial studies
This phase 1, randomized study compares metabolic outcomes after weight loss produced by CagriSema versus a low-energy diet. In the first part, participants are randomly assigned to receive either CagriSema or a calorie-reduced diet; in the second part, all participants receive CagriSema. The trial measures how the body uses energy following these different approaches to weight loss over about 1.5 years. Safety and tolerability of the investigational combination are also monitored throughout the study.
Who should consider this trial
Good fit: Adults aged 18–65 with a BMI ≥30 kg/m2, without diabetes, who can undergo MRI and are willing to follow study procedures may be eligible.
Not a fit: People with diabetes, pregnant or breastfeeding individuals, those with MRI contraindications, severe eating disorders, or who cannot follow the provided diet or procedures may not receive benefit from this study.
Why it matters
Potential benefit: If successful, the study could show whether drug-induced weight loss causes different metabolic changes than diet-induced weight loss, helping guide treatment choices.
How similar studies have performed: Previous clinical work with the cagrilintide plus semaglutide combination has produced larger weight loss than semaglutide alone, but direct comparisons of metabolic effects versus calorie-restricted diet remain limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Orlando, Florida and 1 other locations
- Advent Health-Res Inst — Orlando, Florida, United States (Recruiting)
- Pennington Biomed Res Ctr — Baton Rouge, Louisiana, United States (Recruiting)
Study contacts
- Study coordinator: Novo Nordisk
- Email: clinicaltrials@novonordisk.com
- Phone: (+1) 866-867-7178
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.