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Recruiting NCT07597018

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

Phase I Interventional Obesity Overweight

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cagrilintide D, Cagrilintide B and placebo semaglutide I.
Who it may be relevant to
Registry conditions: Obesity, Overweight. Basic parameters: 18 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Cagrilintide D
    Cagrilintide D will be administered subcutaneously.
  • Drug Cagrilintide B and placebo semaglutide I
    Cagrilintide B and placebo semaglutide I will be administered subcutaneously

Primary outcome measures

  • 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)]
  • 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)]
Secondary outcome measures (12)
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • 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)]
  • Number of treatment-emergent adverse events (TEAEs) [Time frame: Day 1 (randomisation) to Day 162 (end of study)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • Parexel International GmbH — Berlin

Identifiers

NCT: NCT07597018 · NN9833-8285 · U1111-1314-9337 · 2025-521384-12

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗