Overweight, Obesity
Conditions
Brief summary
The purpose of this clinical study is to look at how well a study medicine called cagrilintide helps people living with excess body weight to lose weight. Participants will either get cagrilintide, the active study medicine being tested or placebo, a medicine that has no active medicine in it. Which treatment participants get is decided by chance. Cagrilintide is a new medicine under development that doctors cannot prescribe yet, but it has been tested in humans before. Participants will be in this clinical study for about 9 months.
Interventions
DRUGCagrilintide
Cagrilintide will be administered subcutaneously.
Placebo matched to cagrilintide will be administered subcutaneously.
Placebo matched to semaglutide will be administered subcutaneously.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * Male or female (sex assigned at birth, inclusive of all gender identities). * Age 18 years or above 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), or BMI \>= 27.0 kg/m\^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease.
Exclusion criteria
* History of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D). * Previous dosing of marketed or non-marketed amylin-based compounds. * Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative change in body weight | From baseline (week 0) to end of treatment (week 26) | Measured as percentage (%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment Emergent Serious Adverse Events (TESAEs) | From baseline (week 0) to end of study (week 33) | Measured as count of events. |
| Number of Treatment Emergent Adverse Events (TEAEs) | From baseline (week 0) to end of study (week 33) | Measured as count of events. |
Countries
Greece, Hungary, Portugal, Serbia, Sweden, United States
Contacts
CONTACTNovo Nordisk
STUDY_DIRECTORClinical Transparency (dept. 2834)
Novo Nordisk A/S
Outcome results
None listed