A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight

NCT ID: NCT06131437

Last Updated: 2026-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

809 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2026-01-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study will look at how well CagriSema compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CagriSema 2.4 mg/2.4 mg

Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 84 weeks.

Group Type EXPERIMENTAL

Cagrilintide

Intervention Type DRUG

Cagrilintide will be administered subcutaneously.

Semaglutide

Intervention Type DRUG

Semaglutide will be administered subcutaneously.

Tirzepatide 15 mg

Participants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 84 weeks.

Group Type ACTIVE_COMPARATOR

Tirzepatide

Intervention Type DRUG

Tirzepatide will be administered subcutaneously.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cagrilintide

Cagrilintide will be administered subcutaneously.

Intervention Type DRUG

Semaglutide

Semaglutide will be administered subcutaneously.

Intervention Type DRUG

Tirzepatide

Tirzepatide will be administered subcutaneously.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Male or female
* Age 18 years or above at the time of signing the informed consent
* Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m\^2)

Exclusion Criteria

* Glycated haemoglobin (HbA1c) ≥ 6.5 % (48 millimoles per mole \[mmol/mol\]) as measured by the central laboratory at screening
* History of type 1 or type 2 diabetes mellitus
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Univ of Alabama Birmingham

Birmingham, Alabama, United States

Site Status

Chambliss Clinical Trials LLC

Montgomery, Alabama, United States

Site Status

FDRC

Costa Mesa, California, United States

Site Status

Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status

Univ of Colorado at Denver

Aurora, Colorado, United States

Site Status

Yale University School Of Medicine

New Haven, Connecticut, United States

Site Status

Northeast Research Institute

Fleming Island, Florida, United States

Site Status

Jacksonville Ctr For Clin Res

Jacksonville, Florida, United States

Site Status

South Broward Research LLC

Miramar, Florida, United States

Site Status

Hope Clin Res & Wellness

Conyers, Georgia, United States

Site Status

East West Med Res Inst

Honolulu, Hawaii, United States

Site Status

Great Lakes Clinical Trials

Chicago, Illinois, United States

Site Status

Endeavor Health

Skokie, Illinois, United States

Site Status

Evanston Premier Hlthcr Res

Skokie, Illinois, United States

Site Status

Midwest Inst For Clin Res

Indianapolis, Indiana, United States

Site Status

Northern Pines Hlth Ctr, PC

Buckley, Michigan, United States

Site Status

StudyMetrix Research LLC

City of Saint Peters, Missouri, United States

Site Status

Comprehensive Weight Ctrl Prog

New York, New York, United States

Site Status

University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Medication Mgmnt, LLC_Grnsboro

Greensboro, North Carolina, United States

Site Status

PharmQuest Life Sciences LLC

Greensboro, North Carolina, United States

Site Status

Accellacare_NC

Raleigh, North Carolina, United States

Site Status

Accellacare

Wilmington, North Carolina, United States

Site Status

New Venture Medical Research

Wadsworth, Ohio, United States

Site Status

Lynn Institute of Norman

Norman, Oklahoma, United States

Site Status

The University of Penn Center

Philadelphia, Pennsylvania, United States

Site Status

Clinical Res Collaborative

Cumberland, Rhode Island, United States

Site Status

Medical University Of South Carolina

Charleston, South Carolina, United States

Site Status

Coastal Carolina Res Ctr

North Charleston, South Carolina, United States

Site Status

Hillcrest Clinical Research

Simpsonville, South Carolina, United States

Site Status

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Site Status

Holston Medical Group_Bristol

Bristol, Tennessee, United States

Site Status

Holston Medical Group

Kingsport, Tennessee, United States

Site Status

Amarillo Med Spec LLP

Amarillo, Texas, United States

Site Status

Elligo Clin Res Centre

Austin, Texas, United States

Site Status

UT Health University of Texas

Bellaire, Texas, United States

Site Status

Baylr Sctt White Rs Inst, Endo

Dallas, Texas, United States

Site Status

Velocity Clin Res, Dallas

Dallas, Texas, United States

Site Status

UT Southwestern Medical Center-CRU

Dallas, Texas, United States

Site Status

DCOL Ctr for Clin Res

Longview, Texas, United States

Site Status

Washington Cntr Weight Mgmt

Arlington, Virginia, United States

Site Status

Health Res of Hampton Roads

Newport News, Virginia, United States

Site Status

National Clin Res Inc.

Richmond, Virginia, United States

Site Status

Selma Medical Associates

Winchester, Virginia, United States

Site Status

Capital Clin Res Ctr,LLC

Olympia, Washington, United States

Site Status

Rainier Clin Res Ctr Inc

Renton, Washington, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

U1111-1292-4835

Identifier Type: OTHER

Identifier Source: secondary_id

NN9838-7832

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.