Overweight, Obese
Conditions
Brief summary
This trial is being done to look at the safety and effect of combining cagrilintide and NNC0480-0389 in people living with overweight and obesity compared to taking cagrilintide alone. In one period participants will get two medicines: cagrilintide and NNC0480-0389. In the other period, participants will get cagrilintide together with a placebo version of NNC0480-0389.The placebo looks like the real treatment but does not have any active medicine in it. Cagrilintide and NNC0480-0389 is a new medicine being tested to help people with type 2 diabetes and/or overweight or obesity. The trial medicines is not yet approved for use outside of clinical trials. Participants will receive the trial medicines the way the trial doctor has described. The study will last for about 4.5 months.
Interventions
Participants will receive GIP subcutaneously.
DRUGCagrilintide
Participants will receive Cagrilintide subcutaneously.
DRUGPlacebo GIP
Participants will receive placebo matched to GIP subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Female at birth. * Age 18-64 years (both inclusive) at the time of signing the informed consent. * Body mass index (BMI) between 27.0 kilograms per square meter (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening. * Overweight should be due to excess adipose tissue, as judged by the investigator. * Considered eligible with suitable veins for cannulation or repeated venepuncture, as judged by the investigator. * No clinically significant findings during medical history, physical examination, vital signs, electrocardiogram or clinical laboratory tests at the screening visit, as assessed by the investigator.
Exclusion criteria
* Known or suspected hypersensitivity to study intervention(s) or related products. * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method. * Current participation (i.e., dosing) in any other interventional clinical study within 90 days before screening. * Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol. * Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening, including incretin-based treatment(s). * Previous or planned (during the study period) obesity treatment with surgery. However, the following are allowed: 1. Liposuction and/or abdominoplasty, if performed greater than symbol (\>) 1 year before screening. 2. Adjustable gastric banding, if the band has been removed \> 1 year before screening. 3. Intragastric balloon, if the balloon has been removed \> 1 year before screening. 4. Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed \> 1 year before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Emergent Adverse Events (TEAEs) nausea, vomiting and diarrhoea | From first investigational medicinal products (IMP) administration (visit 2, day 1 or visit 9, day 74) to the end of treatment visit (Visit 2, day 16 or Visit 9, day 89) | Measured as number of events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total number of Adverse Events | First IMP administration (visit 2, day 1) to the end of treatment follow up visit (visit 16, day 142) | Measured as number of events. |
Countries
United Kingdom
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed