Current partner codePEPTIDESDE
NCT07597018·Phase 1·INTERVENTIONAL

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

Status

Recruiting

Phase

Phase 1

Enrollment

234

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    May 19, 2026

  2. Study start

    May 18, 2026

  3. Primary completion

    May 28, 2027

  4. Study completion

    Jun 1, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jun 26, 2026

Outcomes

What the study measures.

Primary outcomes

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)

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
64 Years
Sex
ALL
Healthy volunteers
No

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.

Study locations

1 registered sites.

Germany. Showing up to 24 locations stored in the fast local snapshot.

Parexel International GmbH

Berlin, Germany

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Cagrilintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.