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NCT Number: NCT07597018

A Research Study to Compare Blood Levels of Cagrilintide After Multiple Doses of Different Versions of Cagrilintide in Adults With Overweight or Obesity

This clinical study is testing two versions of the study medicine cagrilintide. The purpose of the study is to compare these two versions to understand their effects in participants with overweight or obesity. Participants will receive either cagrilintide version D or cagrilintide version B, and which treatment participants receive is decided by chance. Participants will be in this clinical study for about 6 months.

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Key information

Conditions

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

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Parexel International GmbH

Berlin, 14050, Germany

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Aged 18-64 years (both inclusive) at the time of signing informed consent
  • Body mass index (BMI) between 27.0 and 34.9 kilograms per square metre (kg/m^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
  • Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion criteria

  • Previous participation in study(s) with an amylin analogue. Participation is defined as randomisation.
  • Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.

Treatment and study plan

Cagrilintide D

Drug

Cagrilintide D will be administered subcutaneously.

Cagrilintide B and placebo semaglutide I

Drug

Cagrilintide B and placebo semaglutide I will be administered subcutaneously

Primary outcomes

  1. AUC,ss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide s.c.

    Time frame: Day 113 (pre-dose) to Day 120 (post-dose)

    Measured in hour nanomoles per litre (h*nmol/L)

  2. Cmax,ss: maximum concentration of total cagrilintide at steady state after 5th dosing of cagrilintide s.c.

    Time frame: Day 113 (pre-dose) to Day 120 (post-dose)

    Measured in nanomoles per litre (nmol/L).

Secondary outcomes

  1. tmax,ss: time since last dosing to maximum concentration of totala cagrilintide at steady state after 5th dosing of cagrilintide s.c.

    Time frame: Day 113 (pre-dose) to Day 120 (post-dose)

    Measured in hours.

  2. t½,ss: terminal half-life of total cagrilintide at steady state after 5th dosing of cagrilintide s.c.

    Time frame: Day 113 (pre-dose) to Day 162 (post-dose)

    Measured in hours.

  3. Vz/F: the apparent volume of distribution of total cagrilintide during elimination after the 5th dosing of cagrilintide s.c.

    Time frame: Day 113 (pre-dose) to Day 120 (post-dose)

    Measured in litre.

  4. CL/F: total apparent clearance of total cagrilintide after the 5th dosing of cagrilintide s.c.

    Time frame: Day 113 (pre-dose) to Day 120 (post-dose)

    Measured in litre per hours.

  5. AUC,ss: area under the cagrilintide and metabolites concentration-time curve at steady state after the 5th dosing of cagrilintide s.c.

    Time frame: Day 113 (pre-dose) to Day 120 (post-dose)

    Measured in hours*nmol/L.

  6. Cmax,ss: maximum concentration of cagrilintide and metabolites at steady state after the 5th dosing of cagrilintide s.c.

    Time frame: Day 113 (pre-dose) to Day 120 (post-dose)

    Measured in nmol/L.

  7. tmax,ss: time since the last dosing to maximum concentration of cagrilintide and metabolites at steady state after the 5th dosing of cagrilintide s.c.

    Time frame: Day 113 (pre-dose) to Day 120 (post-dose)

    Measured in hours.

  8. t½,ss: terminal half-life of cagrilintide parent at steady state after the 5th dosing of cagrilintide s.c.

    Time frame: Day 113 (pre-dose) to Day 120 (post-dose)

    Measured in hours.

  9. AUC,ss: area under the total cagrilintide concentration-time curve at steady state after the 4th dosing of cagrilintide s.c

    Time frame: Day 22 (pre-dose) to Day 29 (post-dose)

    Measured in hours*nmol/L.

  10. Cmax,ss: maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c.

    Time frame: Day 22 (pre-dose) to Day 29 (post-dose)

    Measured in nmol/L.

  11. tmax,ss: time since the last dosing to maximum concentration of total cagrilintide at steady state after the 4th dosing of cagrilintide s.c.

    Time frame: Day 22 (pre-dose) to Day 29 (post-dose)

    Measured in hours.

  12. Number of treatment-emergent adverse events (TEAEs)

    Time frame: Day 1 (randomisation) to Day 162 (end of study)

    Measured in count of events.

  13. Number of treatment-emergent serious adverse events (TESAEs)

    Time frame: Day 1 (randomisation) to Day 162 (end of study)

    Measured in count of events.

Study contacts

Contact information is provided by the study sponsor or research team.

Novo Nordisk

CONTACT

[email protected]

(+1) 866-867-7178

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Bioequivalence Study of Cagrilintide B + Placebo Semaglutide I and Cagrilintide D Once Weekly in Participants With Overweight or Obesity

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 19, 2026
Registry last updated
Jun 26, 2026

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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