A Study to See How Metabolism is Influenced by Weight Loss Due to Intervention With Cagrilintide and Semaglutide Compared to Diet

NCT07184086 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: NN9838-8215U1111-1316-8299
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

In this study we will be looking into how CagriSema influences metabolism (the process by which food is used to supply energy for the body) compared to a diet. CagriSema is a new investigational medicine. CagriSema cannot yet be prescribed by doctors but has previously been tested in humans. The study is split into 2 parts. In the first part of the study, participants will either get CagriSema or a weight loss diet (calorie reduced). In the second part of the study,all participants will get CagriSema. Which treatment participants get in the first part of the study is decided by chance. Like all medicines, the study medicine may have side effects. The study will last for about 1.5 years.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• Change in sleeping metabolic rate (SMR)

  Measured as kilojoules (kJ) per day.

  Baseline (Week 0) to Week 20

Secondary Outcomes (3)

• Change in 24-hour energy expenditure

  Baseline (Week 0) to Week 20

• Change in resting metabolic rate (RMR)

  Baseline (Week 0) to Week 20

• Change in basal metabolic rate (BMR)

  Baseline (Week 0) to Week 20

Study Arms (2)

CagriSema (Cagrilintide + Semaglutide) / CagriSema

EXPERIMENTAL

Participants will receive subcutaneous (s.c.) dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen in Period A for up to 20 weeks and continue to receive the same dose escalation regimen until maximum dose is reached in Period B for up to 52 weeks.

Drug: CagriSema (Cagrilintide B + semaglutide I)

Low Energy Diet (LED) / CagriSema

EXPERIMENTAL

Participants will receive a dietary intervention in period A for up to 20 weeks followed by a s.c. dose of CagriSema (cagrilintide B and semaglutide I) in a dose escalation regimen until maximum dose is reached in Period B for up to 52 weeks.

Drug: CagriSema (Cagrilintide B + semaglutide I); Behavioral: Low Energy Diet

Interventions

CagriSema (Cagrilintide B + semaglutide I) DRUG

Cagrilintide and semaglutide will be administered subcutaneously.

CagriSema (Cagrilintide + Semaglutide) / CagriSema; Low Energy Diet (LED) / CagriSema

Low Energy Diet BEHAVIORAL

Participants will receive dietary intervention as per diet intervention manual.

Low Energy Diet (LED) / CagriSema

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female (sex assigned at birth).
• Age 18-65 years (both inclusive) at the time of signing the informed consent.
• Body Mass Index (BMI) greater than or equal to (≥) 30.0 kilograms per square meter (kg/m\^2) at screening (Visit 1). Excess body weight should be due to excess adipose tissue, as judged by the investigator.

You may not qualify if:

• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.
• History of diabetes mellitus of any type, other than gestational diabetes mellitus.
• Claustrophobia or severe discomfort of being confined in small rooms.
• Contraindication for magnetic resonance imaging (MRI) scanning as per local guidance, including physical limitations that prevent the MRI scan.
• Unusual meal habits (including, but not limited to, eating disorders) and special diet requirements or unwillingness to eat the food provided in the study.
• Treatment with metformin or other glucose-lowering agent(s) within 90 days before screening (V1), regardless of indication.
• Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening (Visit 1).
• Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia) within 5 years before screening (Visit 1).
• Physical measurement exceeding the dimensions or load capacity of the magnetic resonance imaging (MRI)/dual-energy X-ray absorptiometry (DEXA) scanner.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (2)

Advent Health-Res Inst

Orlando, Florida, 32804, United States

RECRUITING

Pennington Biomed Res Ctr

Baton Rouge, Louisiana, 70808-4124, United States

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Caloric Restriction

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Energy Intake; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

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: September 13, 2025
• First Posted: September 19, 2025
• Study Start: September 26, 2025
• Primary Completion (Estimated): October 12, 2027
• Study Completion (Estimated): October 12, 2027
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (2)