Obesity
Conditions
Brief summary
The purpose of this clinical study is to look into how study medicines CagriSema (cagrilintide and semaglutide), cagrilintide, and semaglutide affects muscle health in people with excess body weight and slightly higher than normal blood sugar as they lose weight. Participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to treat people with type 2 diabetes and excess body weight) or placebo (a placebo looks like the treatment being tested but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants will be in this clinical study up to 15 months.
Interventions
DRUGCagrilintide
Participants will receive cagrilintide subcutaneously.
DRUGSemaglutide
Participants will receive semaglutide subcutaneously.
Participants will receive placebo matched to cagrilintide subcutaneously.
Participants will receive placebo matched to semaglutide subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Male or female. * Age 50-70 years (both inclusive) at the time of signing the informed consent. * Body Mass index (BMI) between 30.0 kilograms per square meter (kg/m\^2) and 39.9 kg/m\^2 (both inclusive) at screening (V1). * Excess body weight should be due to excess adipose tissue, as judged by the investigator. * Participant has a wish to lose at least 25 percentage (%) of body weight within 52 weeks of treatment.
Exclusion criteria
* Any leg amputations. * Female participants who are not postmenopausal at screening. * Any clinically significant body weight change (greater than or equal to \[\>=\] 5% self-reported change) or dieting attempts within 90 days before screening. * Treatment with any glucagon-like peptide-1 (GLP-1) receptor agonist or a medication with GLP-1 activity within 90 days before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in insulin-stimulated fluorodeoxyglucose (FDG) uptake in skeletal muscle | Baseline to Week 51 | Measured in micromoles per 100 grams per minute (μmol/100g/min). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in insulin-stimulated FDG uptake in skeletal muscle | Baseline to Week 20 | Measured in μmol/100g/min. |
Countries
Denmark
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency dept. 2834
Novo Nordisk A/S
Outcome results
None listed