A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight

Recruiting now · Phase 3

Conditions studied: Obesity, Type 2 Diabetes

In brief

This clinical study is testing how the study medicine CagriSema helps people living with obesity, with or without type 2 diabetes (T2D), lose weight. The purpose of the study is to find out how safe and effective CagriSema is for body weight loss in these participants. Participants will receive either CagriSema or semaglutide, and which treatment participants receive is decided by chance. CagriSema is a new study medicine being tested, while semaglutide is a medicine that doctors can already prescribe. The study will last for about 83 weeks

Key facts

Study ID

NCT07564414

Run by

Novo Nordisk A/S

People needed

2500

Starts

2026-05-21

Expected to finish

2028-04-19

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Cahaba Research — Pelham, Alabama, United States (enrolling)
• Elligo Health Research Inc — Gilbert, Arizona, United States (enrolling)
• Velocity Clinical Research-Phoenix — Phoenix, Arizona, United States (enrolling)
• Arkansas Clinical Research — Little Rock, Arkansas, United States (enrolling)
• Woodland Int. Research Group — Little Rock, Arkansas, United States (enrolling)
• Headlands Research California, LLC — Escondido, California, United States (enrolling)
• Neighborhood Healthcare — Escondido, California, United States (enrolling)
• Diabetes & Endocrine Specialists - La Mesa — La Mesa, California, United States (enrolling)
• Clinical Trials Research_Sacramento — Lincoln, California, United States (enrolling)
• Loma Linda University Faculty Medical Clinics — Loma Linda, California, United States (enrolling)
• Pacific Clinical Studies — Los Alamitos, California, United States (enrolling)
• Valley Clinical Trials — Northridge, California, United States (enrolling)
• Desert Oasis Healthcare — Palm Springs, California, United States (enrolling)
• Linda Vista Health Care Ctr — San Diego, California, United States (enrolling)
• Velocity Clin Res - Van Nuys — Van Nuys, California, United States (enrolling)
• Flourish Research - CA — Walnut Creek, California, United States (enrolling)
• University of Colorado Hospital — Aurora, Colorado, United States (enrolling)
• TBMR & Alcanza — Clearwater, Florida, United States (enrolling)
• Northeast Research Institute — Fleming Island, Florida, United States (enrolling)
• Northeast Research Institute — Jacksonville, Florida, United States (enrolling)
• Westside Center For Clinical Research — Jacksonville, Florida, United States (enrolling)
• Bioclinical Research Alliance — Miami, Florida, United States (enrolling)
• New Horizon Research Center — Miami, Florida, United States (enrolling)
• South Broward Research LLC — Miramar, Florida, United States (enrolling)
• Uni of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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