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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

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…

ClinicalTrials.gov IDNCT07564414

PhasePHASE3

Enrollment2500

SponsorNovo Nordisk A/S

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Obesity, Type 2 Diabetes

About this study

Interventions

Drug: Cagrisema — Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
Drug: Semaglutide — Semaglutide will be administered subcutaneously.

Primary outcomes

Relative change in body weight (From randomisation (week 0) to end of treatment (week 72))

Eligibility information

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.

Study locations

Uni of Alabama at Birmingham, Birmingham, Alabama 35294 United States
Cahaba Research, Pelham, Alabama 35124 United States
Elligo Health Research Inc, Gilbert, Arizona 85296 United States
Velocity Clinical Research-Phoenix, Phoenix, Arizona 85006 United States
Arkansas Clinical Research, Little Rock, Arkansas 72205 United States
Woodland Int. Research Group, Little Rock, Arkansas 72211 United States
Headlands Research California, LLC, Escondido, California 92025 United States
Neighborhood Healthcare, Escondido, California 92025 United States
Diabetes & Endocrine Specialists - La Mesa, La Mesa, California 91942 United States
Clinical Trials Research_Sacramento, Lincoln, California 95648 United States

Showing 10 of 303 reported sites. See the official listing for all locations.

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.