Obesity & Overweight
Conditions
Brief summary
This study will compare two different ways of giving cagrilintide and semaglutide for treating overweight and obesity. The medicines will either be given together in 1 injection or as 2 separate injections. The aim of the study is to find out how the different ways of injection affect the level of the medicines in the blood. For the first 14 weeks of the study, participants will get cagrilintide and semaglutide as 2 separate injections. Then participants will either switch to getting the medicines as a combined injection or continue to get the separate injections for 8 weeks. Which treatment participants get after the first 14 weeks is decided by chance. Participants will get the study medicines once a week for 22 weeks. A study nurse at the clinic will inject the medicines with a thin needle in participants stomach area. The study will last for about 8 months.Participants will have 28 clinic visits with the study staff. For 4 of these visits, participants will stay in the clinic for 5 nights. Participants will have blood drawn at 21 visits. Participants will have clinical assessments and participants will be asked about their health, medical history and habits including mental health questionnaires. For women: Participants must not be able to become pregnant if they wish to participate in this study.
Interventions
DRUGCagrilintide
Once weekly doses of cagrilintide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. for 2 weeks
DRUGsemaglutide
Once weekly doses of semaglutide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. over 2 weeks
Cagrilintide and semaglutide combined and administered using the DV3384 manual syringe
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
The trial consists of a Part A with multiple weekly dosings at site and a Part B with a single dose (SD) part of the first dose step in Part A.
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Male or female of non-childbearing potential (NCBP) * Aged 18-55 years (both inclusive) at the time of signing informed consent * Body mass index (BMI) between 27.0 and 39.9 kg/m\^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator
Exclusion criteria
* Previous participation in trial(s) with an amylin analogue unless documented that the subject was assigned to placebo treatment. Participation is defined as randomisation * Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-168h,cagri,2.4/2.4mg,SS area under the cagrilintide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg | Day 148 (pre-dose) to Day 155 (168 hours post-dose) | measured in nmol⸱h/L |
| Cmax,cagri,2.4/2.4mg,SS maximum concentration of cagrilintide at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg | Day 148 (pre-dose) to Day 155 (168 hours post-dose) | measured in nmol/L |
| AUC0-168h,sema,2.4/2.4mg,SS area under the semaglutide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg | Day 148 (pre-dose) to Day 155 (168 hours post-dose) | measured in nmol⸱h/L |
| Cmax,sema,2.4/2.4mg,SS maximum concentration of semaglutide at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg | Day 148 (pre-dose) to Day 155 (168 hours post-dose) | measured in nmol/L |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-168h,cagri,1.7/1.7mg,SS area under the cagrilintide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dose of cagrilintide 1.7 mg in combination with semaglutide 1.7 mg | Day 120 (pre-dose) to Day 127 (168 hours post-dose) | measured in nmol⸱h/L |
| AUC0-168h,sema,1.7/1.7mg,SS area under the semaglutide concentration-time curve during a dosing interval (0-168 hours) at steady state after last dose of semaglutide 1.7 mg in combination with cagrilintide 1.7 mg | Day 120 (pre-dose) to Day 127 (168 hours post-dose) | measured in nmol⸱h/L |
| tmax,cagri,2.4/2.4mg,SS time since last dosing to maximum concentration of cagrilintide at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg | Day 148 (pre-dose) to Day 155 (168 hours post-dose) | measured in hours |
| PART B: Number of treatment emergent adverse events | From time of dosing (Day 1) to follow-up (Day 29) | Count |
| PART A: Number of treatment emergent adverse events | From time of dosing (Day 1) to follow-up (Day 186) | count |
| t½,cagri,2.4/2.4mg,SS terminal half-life of cagrilintide at steady state after last dosing of cagrilintide 2.4 mg in combination with semaglutide 2.4 mg | Day 148 (pre-dose) to Day 186 (912 hours post-dose) | measured in hours |
| tmax,sema,2.4/2.4mg,SS time since last dosing to maximum concentration of semaglutide at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg | Day 148 (pre-dose) to Day 155 (168 hours post-dose) | measured in hours |
| t½,sema,2.4/2.4mg,SS terminal half-life of semaglutide at steady state after last dosing of semaglutide 2.4 mg in combination with cagrilintide 2.4 mg | Day 148 (pre-dose) to Day 186 (912 hours post-dose) | measured in hours |
Countries
Canada, Denmark
Outcome results
None listed