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

NCT06131437 | Completed Phase 3 FDA Drug

• 2 other identifiers: NN9838-7832U1111-1292-4835
• Study Type: interventional
• Target: 809
• Locations: 1 country
• Sites: 46

Brief Summary

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight

  Measured in percentage (%).

  From baseline (week 0) to end of treatment (week 84)

Secondary Outcomes (14)

• To confirm superiority of CagriSema versus tirzepatide: Relative change in body weight

  From baseline (week 0) to end of treatment (week 84)

• Achievement of greater than or equal to (≥) 25% weight reduction

  From baseline (week 0) to end of treatment (week 84)

• Achievement of ≥ 30% weight reduction

  From baseline (week 0) to end of treatment (week 84)

• Change in waist circumference

  From baseline (week 0) to end of treatment (week 84)

• Change in systolic blood pressure (SBP)

  From baseline (week 0) to end of treatment (week 84)

Study Arms (2)

CagriSema 2.4 mg/2.4 mg

EXPERIMENTAL

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.

Drug: Cagrilintide; Drug: Semaglutide

Tirzepatide 15 mg

ACTIVE COMPARATOR

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

Drug: Tirzepatide

Interventions

Cagrilintide DRUG

Cagrilintide will be administered subcutaneously.

CagriSema 2.4 mg/2.4 mg

Semaglutide DRUG

Semaglutide will be administered subcutaneously.

CagriSema 2.4 mg/2.4 mg

Tirzepatide DRUG

Tirzepatide will be administered subcutaneously.

Tirzepatide 15 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (46)

Univ of Alabama Birmingham

Birmingham, Alabama, 35294, United States

Location

Chambliss Clinical Trials LLC

Montgomery, Alabama, 36106, United States

Location

FDRC

Costa Mesa, California, 92627, United States

Location

Diablo Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Univ of Colorado at Denver

Aurora, Colorado, 80045, United States

Location

Yale University School Of Medicine

New Haven, Connecticut, 06519, United States

Location

Northeast Research Institute

Fleming Island, Florida, 32003, United States

Location

Jacksonville Ctr For Clin Res

Jacksonville, Florida, 32216, United States

Location

South Broward Research LLC

Miramar, Florida, 33027, United States

Location

Hope Clin Res & Wellness

Conyers, Georgia, 30094, United States

Location

East West Med Res Inst

Honolulu, Hawaii, 96814, United States

Location

Great Lakes Clinical Trials

Chicago, Illinois, 60640, United States

Location

Endeavor Health

Skokie, Illinois, 60077, United States

Location

Evanston Premier Hlthcr Res

Skokie, Illinois, 60077, United States

Location

Midwest Inst For Clin Res

Indianapolis, Indiana, 46260, United States

Location

Northern Pines Hlth Ctr, PC

Buckley, Michigan, 49620, United States

Location

StudyMetrix Research LLC

City of Saint Peters, Missouri, 63303, United States

Location

Comprehensive Weight Ctrl Prog

New York, New York, 10021, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Medication Mgmnt, LLC_Grnsboro

Greensboro, North Carolina, 27405, United States

Location

PharmQuest Life Sciences LLC

Greensboro, North Carolina, 27408, United States

Location

Accellacare_NC

Raleigh, North Carolina, 27609, United States

Location

Accellacare

Wilmington, North Carolina, 28401, United States

Location

New Venture Medical Research

Wadsworth, Ohio, 44281, United States

Location

Lynn Institute of Norman

Norman, Oklahoma, 73072, United States

Location

The University of Penn Center

Philadelphia, Pennsylvania, 19104-3317, United States

Location

Clinical Res Collaborative

Cumberland, Rhode Island, 02864, United States

Location

Medical University Of South Carolina

Charleston, South Carolina, 29425, United States

Location

Coastal Carolina Res Ctr

North Charleston, South Carolina, 29405, United States

Location

Hillcrest Clinical Research

Simpsonville, South Carolina, 29681-1538, United States

Location

Spartanburg Medical Research

Spartanburg, South Carolina, 29303, United States

Location

Holston Medical Group_Bristol

Bristol, Tennessee, 37620, United States

Location

Holston Medical Group

Kingsport, Tennessee, 37660, United States

Location

Amarillo Med Spec LLP

Amarillo, Texas, 79124, United States

Location

Elligo Clin Res Centre

Austin, Texas, 78704, United States

Location

UT Health University of Texas

Bellaire, Texas, 77401, United States

Location

Baylr Sctt White Rs Inst, Endo

Dallas, Texas, 75226, United States

Location

Velocity Clin Res, Dallas

Dallas, Texas, 75230, United States

Location

UT Southwestern Medical Center-CRU

Dallas, Texas, 75390, United States

Location

DCOL Ctr for Clin Res

Longview, Texas, 75605, United States

Location

Washington Cntr Weight Mgmt

Arlington, Virginia, 22206, United States

Location

Health Res of Hampton Roads

Newport News, Virginia, 23606, United States

Location

National Clin Res Inc.

Richmond, Virginia, 23294, United States

Location

Selma Medical Associates

Winchester, Virginia, 22601-3834, United States

Location

Capital Clin Res Ctr,LLC

Olympia, Washington, 98502, United States

Location

Rainier Clin Res Ctr Inc

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

cagrilintide; semaglutide; Tirzepatide

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: November 27, 2023
• Primary Completion: December 8, 2025
• Study Completion: January 9, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

US (46)