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OpenTrials
Completed

NCT Number: NCT04940078

A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity

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.

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Key information

Conditions

Obesity & Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Altasciences Company Inc., Montreal, Quebec, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cagrilintide

Drug

Once weekly doses of cagrilintide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. for 2 weeks

semaglutide

Drug

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

Drug

Cagrilintide and semaglutide combined and administered using the DV3384 manual syringe

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. PART A: Number of treatment emergent adverse events

    Time frame: From time of dosing (Day 1) to follow-up (Day 186)

    count

  8. PART B: Number of treatment emergent adverse events

    Time frame: From time of dosing (Day 1) to follow-up (Day 29)

    Count

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Investigation of Pharmacokinetics Following Co-administration of Cagrilintide (NNC0174-0833) and Semaglutide Versus Separate Injections in Subjects With Overweight or Obesity

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 25, 2021
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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