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

NCT07564414 · tracked via the Priya Life Science USA tracker

Sponsor

Novo Nordisk A/S

Phase

Phase 3

Started

2026-05-21

Last updated

2026-08-31

Condition(s) studied

ObesityType 2 Diabetes

Investigational drug(s) / intervention(s)

CagrisemaSemaglutide

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

Semaglutide: Semaglutide will be administered subcutaneously.

Study summary

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Relative change in body weight — From randomisation (week 0) to end of treatment (week 72)
Measured as percentage (%).

Trial sites (303)

Facility	City	Region	Status
Uni of Alabama at Birmingham	Birmingham	Alabama	Active Not Recruiting
Cahaba Research	Pelham	Alabama	Active Not Recruiting
Elligo Health Research Inc	Gilbert	Arizona	Active Not Recruiting
Velocity Clinical Research-Phoenix	Phoenix	Arizona	Active Not Recruiting
Arkansas Clinical Research	Little Rock	Arkansas	Active Not Recruiting
Woodland Int. Research Group	Little Rock	Arkansas	Active Not Recruiting
Headlands Research California, LLC	Escondido	California	Active Not Recruiting
Neighborhood Healthcare	Escondido	California	Active Not Recruiting
Diabetes & Endocrine Specialists - La Mesa	La Mesa	California	Active Not Recruiting
Clinical Trials Research_Sacramento	Lincoln	California	Active Not Recruiting
Loma Linda University Faculty Medical Clinics	Loma Linda	California	Active Not Recruiting
Pacific Clinical Studies	Los Alamitos	California	Active Not Recruiting
Valley Clinical Trials	Northridge	California	Active Not Recruiting
Desert Oasis Healthcare	Palm Springs	California	Active Not Recruiting
Linda Vista Health Care Ctr	San Diego	California	Active Not Recruiting
Velocity Clin Res - Van Nuys	Van Nuys	California	Active Not Recruiting
Flourish Research - CA	Walnut Creek	California	Active Not Recruiting
University of Colorado Hospital	Aurora	Colorado	Completed
TBMR & Alcanza	Clearwater	Florida	Active Not Recruiting
Northeast Research Institute	Fleming Island	Florida	Active Not Recruiting
Northeast Research Institute	Jacksonville	Florida	Active Not Recruiting
Westside Center For Clinical Research	Jacksonville	Florida	Active Not Recruiting
Bioclinical Research Alliance	Miami	Florida	Active Not Recruiting
New Horizon Research Center	Miami	Florida	Active Not Recruiting
South Broward Research LLC	Miramar	Florida	Active Not Recruiting
West Orange Endocrinology	Ocoee	Florida	Active Not Recruiting
Oviedo Medical Research, LLC	Oviedo	Florida	Active Not Recruiting
Clinical Trial Services Corp	Pembroke Pines	Florida	Active Not Recruiting
Hope Clin Res & Wellness	Conyers	Georgia	Active Not Recruiting
Center for Adv Res & Education	Gainesville	Georgia	Active Not Recruiting
Endocrine Research Solutions, Inc	Roswell	Georgia	Active Not Recruiting
North Georgia Clinical Research	Woodstock	Georgia	Active Not Recruiting
Solaris Clinical Research	Meridian	Idaho	Active Not Recruiting
Cedar-Crosse Research Center	Chicago	Illinois	Active Not Recruiting
Macoupin Fam Practice Ctr, LLP	Gillespie	Illinois	Active Not Recruiting
Clinical Investigation Spec Gurnee	Gurnee	Illinois	Active Not Recruiting
Endeavor Health	Skokie	Illinois	Active Not Recruiting
Evanston Premier Hlthcr Res	Skokie	Illinois	Active Not Recruiting
Iowa Diabetes Research	West Des Moines	Iowa	Active Not Recruiting
Alliance for Multispecialty Research	Newton	Kansas	Active Not Recruiting

+ 263 more sites — see the full list on the official registry below.

On this site

📄 Ozempic (semaglutide) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07564414 on ClinicalTrials.gov ↗ ← All trials in the USA