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

Investigation of Pharmacokinetics of Two Different Presentations of Cagrilintide in Participants With Overweight and Obesity

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Overweight
• Intervention / Treatment: Drug: Cagrilintide D; Drug: Cagrilintide B

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novo Nordisk; Phone Number: (+1) 866-867-7178; Email: clinicaltrials@novonordisk.com

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion, Phoenix

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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).

  1. As declared by the participant, reported in the medical records or at the investigator's discretion.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cagrilintide B; Participants will receive cagrilintide B subcutaneously once weekly for 5 weeks.	Drug: Cagrilintide B; Cagrilintide B will be administered subcutaneously.
Experimental: Cagrilintide D; Participants will receive cagrilintide D subcutaneously once weekly for 5 weeks.	Drug: Cagrilintide D; Cagrilintide D will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCss: area under the total cagrilintide concentration-time curve at steady state after 4th dosing of cagrilintide	Measured as h*nmol/L.	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	Measured as nmol/L.	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	Measured as h*nmol/L.	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	Measured as nmol/L.	From Pre-dose at Day 1 to Day 8

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2026
• Primary Completion (Estimated): September 3, 2026
• Study Completion (Estimated): September 3, 2026

Study Registration Dates

• First Submitted: May 17, 2026
• First Submitted That Met QC Criteria: May 17, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: NN9833-8819; U1111-1336-5994 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No