A Research Study to Compare Blood Levels of Two Different Versions of Cagrilintide in Adults With Excess Body Weight

NCT07605052 | Not Yet Recruiting Phase 1 FDA Drug

• 2 other identifiers: NN9833-8819U1111-1336-5994
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this clinical study is to compare 2 different versions cagrilintide and see how these work in people living with excess body weight. Participant will get either cagrilintide B or cagrilintide D injections. Which treatment participant will get is decided by chance. Participant will be in this clinical study for about 14 weeks.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• AUCss: area under the total cagrilintide concentration-time curve at steady state after 5th dosing of cagrilintide

  Measured as hour\*nanomole per liter (h\*nmol/L).

  From Pre-dose at Day 29 to Day 36

• Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 5th dosing of cagrilintide

  Measured as nanomole per liter (nmol/L).

  From Pre-dose at Day 29 to Day 36

Secondary Outcomes (4)

• AUCss: area under the total cagrilintide concentration-time curve at steady state after 4th dosing of cagrilintide

  From Pre-dose at Day 22 to Day 29

• Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 4th dosing of cagrilintide

  From Pre-dose at Day 22 to Day 29

• AUCss: area under the total cagrilintide concentration-time curve at steady state after 1st dosing of cagrilintide

  From Pre-dose at Day 1 to Day 8

• Cmax,ss: maximum observed concentration of total cagrilintide at steady state after 1st dosing of cagrilintide

  From Pre-dose at Day 1 to Day 8

Study Arms (2)

Cagrilintide B

EXPERIMENTAL

Participants will receive cagrilintide B subcutaneously once weekly for 5 weeks.

Drug: Cagrilintide B

Cagrilintide D

EXPERIMENTAL

Participants will receive cagrilintide D subcutaneously once weekly for 5 weeks.

Drug: Cagrilintide D

Interventions

Cagrilintide B DRUG

Cagrilintide B will be administered subcutaneously.

Cagrilintide B

Cagrilintide D DRUG

Cagrilintide D will be administered subcutaneously.

Cagrilintide D

Eligibility Criteria

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

You may qualify if:

• Age 18-64 years (both inclusive) at the time of signing informed consent.
• Male or female (sex assigned at birth).
• Body mass index (BMI) between 27.0 and 34.9 kilogram per meter square (kg/m\^2) (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator.
• Considered eligible 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 dosing of marketed or non-marketed amylin-agonists (a).
• Any condition, unwillingness or inability which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol (a).
• As declared by the participant, reported in the medical records or at the investigator's discretion.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Celerion, Phoenix

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Overweight; Obesity

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: May 17, 2026
• First Posted: May 22, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): September 3, 2026
• Study Completion (Estimated): September 3, 2026
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)