A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity
- Conditions
- Obesity & Overweight
- Interventions
- Registration Number
- NCT04940078
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Part A: Cagrilintide and semaglutide combined in DV3384 device Cagrilintide and semaglutide Participants will be up-titrated for 14 weeks (dose escalation every 4 weeks and 2 weeks at last dose escalation step prior to randomisation) with cagrilintide and semaglutide administered as separate injections. Followed by 8 weeks of treatment with cagrilintide and semaglutide administered using the DV3384 manual syringe. The 8-week treatment period covers 2 different doses of cagrilintide and semaglutide (1.7/1.7 mg and 2.4/2.4 mg with 4 weeks on each dose combination. Followed by a 38 days follow-up period. Part B: Cagrilintide and semaglutide combined in DV3384 device Cagrilintide and semaglutide Participants will receive a single injection of Cagrilintide 0.25 mg/semaglutide 0.25 mg using the DV3384 manual syringe followed by a 28 days follow-up period. Part A: Cagrilintide and semaglutide in separate syringes Cagrilintide Participants will up-titrated for 14 weeks (dose escalation every 4 weeks and 2 weeks at last dose escalation step prior to randomisation) with cagrilintide and semaglutide administered as separate injections. Followed by 8 weeks treatment with cagrilintide and semaglutide administered as separate injections. The 8-week treatment period covers 2 different doses of cagrilintide and semaglutide (1.7/1.7 mg and 2.4/2.4 mg with 4 weeks on each dose combination). Followed by a 38 days follow-up period. Part A: Cagrilintide and semaglutide in separate syringes semaglutide Participants will up-titrated for 14 weeks (dose escalation every 4 weeks and 2 weeks at last dose escalation step prior to randomisation) with cagrilintide and semaglutide administered as separate injections. Followed by 8 weeks treatment with cagrilintide and semaglutide administered as separate injections. The 8-week treatment period covers 2 different doses of cagrilintide and semaglutide (1.7/1.7 mg and 2.4/2.4 mg with 4 weeks on each dose combination). Followed by a 38 days follow-up period.
- Primary Outcome Measures
Name Time Method 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
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
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
- Secondary Outcome Measures
Name Time Method 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
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
PART A: Number of treatment emergent adverse events From time of dosing (Day 1) to follow-up (Day 186) count
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
PART B: Number of treatment emergent adverse events From time of dosing (Day 1) to follow-up (Day 29) Count
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
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
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
Trial Locations
- Locations (2)
Novo Nordisk Investigational Site
🇩🇰Søborg, Denmark
Altasciences Company Inc.
🇨🇦Montreal, Quebec, Canada