Obesity
Conditions
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 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
DRUGCagriSema (Cagrilintide B + semaglutide I)
Cagrilintide and semaglutide will be administered subcutaneously.
BEHAVIORALLow Energy Diet
Participants will receive dietary intervention as per diet intervention manual.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in sleeping metabolic rate (SMR) | Baseline (Week 0) to Week 20 | Measured as kilojoules (kJ) per day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in 24-hour energy expenditure | Baseline (Week 0) to Week 20 | Measured as kJ per day. |
| Change in resting metabolic rate (RMR) | Baseline (Week 0) to Week 20 | Measured as kJ per day. |
| Change in basal metabolic rate (BMR) | Baseline (Week 0) to Week 20 | Measured as kJ per day. |
Countries
United States
Contacts
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed