DRUG
Cagrilintide
Once weekly doses of cagrilintide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. for 2 weeks
A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity
Status
Completed
Phase
Phase 1
Enrollment
40
Locations
2
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Treatment arms and agents.
DRUG
semaglutide
Once weekly doses of semaglutide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. over 2 weeks
DRUG
Cagrilintide and semaglutide
Cagrilintide and semaglutide combined and administered using the DV3384 manual syringe
Timeline
From registration to results.
First posted
Jun 25, 2021
Study start
Jul 7, 2021
Primary completion
Jan 19, 2022
Study completion
Feb 16, 2022
Results posted
Not reported
Registry updated
Dec 12, 2025
Outcomes
What the study measures.
Primary outcomes
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
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · Day 148 (pre-dose) to Day 155 (168 hours post-dose)
measured in nmol/L
Secondary outcomes
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
Time frame · 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
Time frame · 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
Time frame · 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
Time frame · Day 148 (pre-dose) to Day 186 (912 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
Time frame · 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
Time frame · Day 120 (pre-dose) to Day 127 (168 hours post-dose)
measured in nmol⸱h/L
PART A: Number of treatment emergent adverse events
Time frame · From time of dosing (Day 1) to follow-up (Day 186)
count
PART B: Number of treatment emergent adverse events
Time frame · From time of dosing (Day 1) to follow-up (Day 29)
Count
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 55 Years
- Sex
- ALL
- 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
Study locations
2 registered sites.
Canada · Denmark. Showing up to 24 locations stored in the fast local snapshot.
Altasciences Company Inc.
Montreal, Quebec, Canada
Novo Nordisk Investigational Site
Søborg, Denmark
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Put the record in context.
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