Recruiting
Phase 1

CagriSema

Sponsor:

Novo Nordisk A/S

Code:

NCT07184086

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

CagriSema (Cagrilintide B + semaglutide I)

Low Energy Diet

Study Details

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

Study ID

NCT07184086

Start date

Sep 26, 2025

Status verified date

Oct, 2025

Completion date

Oct 12, 2027

Anticipated

Primary completion date

Oct 12, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion criteria:

  • 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.

Exclusion criteria:

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CagriSema (Cagrilintide + Semaglutide) / CagriSema

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.

experimental: Low Energy Diet (LED) / CagriSema

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.

Interventions

CagriSema (Cagrilintide B + semaglutide I)

Cagrilintide and semaglutide will be administered subcutaneously.

Low Energy Diet

Participants will receive dietary intervention as per diet intervention manual.

Primary outcome measure

  • Change in sleeping metabolic rate (SMR) [ Time Frame: Baseline (Week 0) to Week 20 ]

Central Contacts and Locations

Central contacts

Novo Nordisk

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

Locations

Advent Health-Res Inst

Recruiting

Orlando, Florida, United States, 32804

Pennington Biomed Res Ctr

Recruiting

Baton Rouge, Louisiana, United States, 70808-4124

More Information

Sponsor

Novo Nordisk A/S

Last update posted

Oct 8, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Novo Nordisk A/S on 2025-10-08.