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

NCT07597018 | Not Yet Recruiting Phase 1 FDA Drug

• 3 other identifiers: NN9833-8285U1111-1314-93372025-521384-12
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Obesity; Overweight

Outcome Measures

Primary Outcomes (2)

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

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

  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.

  Measured in nanomoles per litre (nmol/L).

  Day 113 (pre-dose) to Day 120 (post-dose)

Secondary Outcomes (13)

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

  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.

  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.

  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.

  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.

  Day 113 (pre-dose) to Day 120 (post-dose)

Study Arms (4)

Cagrilintide B and Placebo Semaglutide I

EXPERIMENTAL

Participants will receive Cagrilintide B and Placebo semaglutide I subcutaneously once weekly for up to 17 weeks.

Drug: Cagrilintide B and placebo semaglutide I

Cagrilintide D-Injection site 1

EXPERIMENTAL

Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.

Drug: Cagrilintide D

Cagrilintide D-Injection site 2

EXPERIMENTAL

Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.

Drug: Cagrilintide D

Cagrilintide D-Injection site 3

EXPERIMENTAL

Participants will receive Cagrilintide D subcutaneously once weekly for up to 17 weeks.

Drug: Cagrilintide D

Interventions

Cagrilintide D DRUG

Cagrilintide D will be administered subcutaneously.

Cagrilintide D-Injection site 1; Cagrilintide D-Injection site 2; Cagrilintide D-Injection site 3

Cagrilintide B and placebo semaglutide I DRUG

Cagrilintide B and placebo semaglutide I will be administered subcutaneously

Cagrilintide B and Placebo Semaglutide I

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Parexel International GmbH

Berlin, 14050, Germany

Location

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: May 19, 2026
• Study Start: May 18, 2026
• Primary Completion (Estimated): May 28, 2027
• Study Completion (Estimated): May 28, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)