Two doses of CagriSema plus one dose of Semaglutide for weight loss in obesity with or without type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 trial assigns adults with obesity, with or without type 2 diabetes, to receive two different doses of CagriSema or Semaglutide to see how well they promote weight loss and how safe they are over about 83 weeks. Participants are randomly assigned to one of the treatment options, and the study follows them to assess weight change and health effects. CagriSema is a new investigational medicine, while Semaglutide is an approved treatment used for comparison. The trial collects data on safety, tolerability, and efficacy outcomes relevant to weight management in this population.

Why it matters

Who can join: the full rules

Inclusion Criteria :

* Male or female (sex assigned at birth, inclusive of all gender identities).
* Age 18 years or above at the time of signing the informed consent.
* BMI≥ 35.0 kg/m\^2.
* Participants without T2D: No history of T2D and HbA1c \< 6.5% (48 millimoles per mole (mmol/mol)) Participants with T2D: A history of T2D and HbA1c \< 10% (\< 86 mmol/mol). If a participant without a history of diabetes during the screening period receives an HbA1c result of 6.5% (48 mmol/mol) or higher, the investigator or the participant's healthcare provider must confirm the diagnosis of type 2 diabetes before the participant is randomised.

Exclusion Criteria:

* A self-reported change in body weight \> 5% within 90 days before screening, irrespective of medical records.
* Use of any glucagon-like-peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, or amylin analogues, including medication with amylin activity, within 6 months before screening.

Where it's running

• Renew Clinic Sp. z o.o.
  Bialystok, Poland Recruiting
• Uni of Alabama at Birmingham
  Birmingham, Alabama, United States Active not recruiting
• Cahaba Research
  Pelham, Alabama, United States Active not recruiting
• Elligo Health Research Inc
  Gilbert, Arizona, United States Active not recruiting
• Velocity Clinical Research-Phoenix
  Phoenix, Arizona, United States Active not recruiting
• Arkansas Clinical Research
  Little Rock, Arkansas, United States Active not recruiting

+253 more sites. See ClinicalTrials.gov for the full list.

Study contacts

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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Switching to Zenagamtide From Tirzepatide in Adults With Overweight or Obesity With or Without Type 2 Diabetes

  This study tests whether adults who are overweight or have obesity (with or without type 2 diabetes) can switch from tirzepatide to a new treatment called zenagamtide to find a tolerable dose.

  Recruiting at 2 sites Phase 1 Novo Nordisk A/S · Glendale, California and 1 other locations · NCT07868354

• Switching to Zenagamtide from Semaglutide in adults with overweight or obesity, with or without type 2 diabetes

  This study tests whether adults who are already taking semaglutide can successfully switch to zenagamtide at different doses to see which dose works best.

  Recruiting at 2 sites Phase 1 Novo Nordisk A/S · Glendale, California and 1 other locations · NCT07855133

• Using Multimodal Ultrasound to Check Muscle Mass in Metabolic Disease Patients

  This study tests whether a multimodal ultrasound approach can accurately measure muscle mass in people with metabolic syndrome, obesity, sarcopenia, or type 2 diabetes.

  Recruiting Zhangzhou Municipal Hospital · Zhangzhou, Fujian · NCT07836088

• GUB-UCN2 in healthy, obese, and T2D adults: a first-in-human safety and pharmacology study

  This study tests GUB-UCN2 to see if it is safe and tolerable and how it behaves in the body in healthy adults, people with obesity, and people with obesity with or without type 2 diabetes.

  Recruiting Phase 1/2 Gubra A/S · Neuss · NCT07702890

• Semaglutide's effects on heart and muscle mass

  This project will use MRI scans and strength tests over 12 months to see if semaglutide changes body and heart muscle in adults starting the medication.

  Recruiting University of Alberta · Edmonton, Alberta · NCT07272837

• Lifestyle program to try to put Type 2 diabetes into remission for Malaysian adults

  This program tests whether a structured diet and weight‑loss plan can put Malaysian adults with recently diagnosed type 2 diabetes into remission compared with usual care.

  Recruiting at 2 sites IMU University, Malaysia · Seremban, Negeri Sembilam and 1 other locations · NCT07270068

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.