DRUG
Cagrisema
Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously.
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
Status
Recruiting
Phase
Phase 3
Enrollment
2,500
Locations
303
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Interventions
Treatment arms and agents.
DRUG
Semaglutide
Semaglutide will be administered subcutaneously.
Timeline
From registration to results.
First posted
May 4, 2026
Study start
May 21, 2026
Primary completion
Feb 23, 2028
Study completion
Apr 19, 2028
Results posted
Not reported
Registry updated
Jul 30, 2026
Outcomes
What the study measures.
Primary outcomes
Relative change in body weight
Time frame · From randomisation (week 0) to end of treatment (week 72)
Measured as percentage (%).
Secondary outcomes
Relative change in body weight
Time frame · From randomisation (week 0) to end of treatment (week 72)
Measured as %.
Change in Body Mass Index (BMI)
Time frame · From randomisation (week 0) to end of treatment (week 72)
Measured as kilograms per square metre (kg/m\^2).
Number of participants who achieve greater than or equal to (≥) 30% weight reduction
Time frame · From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
Number of participants who achieve ≥25% weight reduction
Time frame · From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
Number of participants who achieve greater ≥ 20% weight reduction
Time frame · From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
Change in waist circumference
Time frame · From randomisation (week 0) to end of treatment (week 72)
Measured in centimetre (cm).
Mean change in body weight
Time frame · From randomisation (week 0) to end of treatment (week 72)
Measured in kilograms (kg).
Number of participants who achieve a BMI less than (<) 30 kg/m^2
Time frame · From randomisation (week 0) to end of treatment (week 72)
Measured as count of participants.
Number of participants who achieve BMI <27 kg/m^2
Time frame · end of treatment (week 72)
Measured as count of participants.
Number of participants who achieve normal BMI, defined as 18.5 lesser than or equal to (≤) BMI < 25 kg/m^2
Time frame · At end of treatment (week 72)
Measured as count of participants.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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
303 registered sites.
Argentina · Australia · Austria · Belgium · Bulgaria · Canada · Czechia · France · Greece · Hungary · Italy · Netherlands · Poland · Portugal · Romania · Slovakia · South Africa · Spain · United States. Showing up to 24 locations stored in the fast local snapshot.
Uni of Alabama at Birmingham
Birmingham, Alabama, United States
Cahaba Research
Pelham, Alabama, United States
Elligo Health Research Inc
Gilbert, Arizona, United States
Velocity Clinical Research-Phoenix
Phoenix, Arizona, United States
Arkansas Clinical Research
Little Rock, Arkansas, United States
Woodland Int. Research Group
Little Rock, Arkansas, United States
Headlands Research California, LLC
Escondido, California, United States
Neighborhood Healthcare
Escondido, California, United States
Diabetes & Endocrine Specialists - La Mesa
La Mesa, California, United States
Clinical Trials Research_Sacramento
Lincoln, California, United States
Loma Linda University Faculty Medical Clinics
Loma Linda, California, United States
Pacific Clinical Studies
Los Alamitos, California, United States
Valley Clinical Trials
Northridge, California, United States
Desert Oasis Healthcare
Palm Springs, California, United States
Linda Vista Health Care Ctr
San Diego, California, United States
Velocity Clin Res - Van Nuys
Van Nuys, California, United States
Flourish Research - CA
Walnut Creek, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
TBMR & Alcanza
Clearwater, Florida, United States
Northeast Research Institute
Fleming Island, Florida, United States
Northeast Research Institute
Jacksonville, Florida, United States
Westside Center For Clinical Research
Jacksonville, Florida, United States
Bioclinical Research Alliance
Miami, Florida, United States
New Horizon Research Center
Miami, Florida, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
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