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

Efficacy and Safety of Cagrilintide 2.4 mg s.c. in Combination With Semaglutide 2.4 mg s.c. (CagriSema s.c. 2.4 mg/2.4 mg) Once-weekly Compared to Tirzepatide 15 mg s.c. Once-weekly in Participants With Obesity

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Cagrilintide; Drug: Semaglutide; Drug: Tirzepatide

• Study Type: Interventional
• Enrollment (Actual): 809
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Univ of Alabama Birmingham
    • Montgomery, Alabama, United States, 36106
      • Chambliss Clinical Trials LLC
  • California
    • Costa Mesa, California, United States, 92627
      • FDRC
    • Walnut Creek, California, United States, 94598
      • Diablo Clinical Research, Inc.
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Univ of Colorado at Denver
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Yale University School of Medicine
  • Florida
    • Fleming Island, Florida, United States, 32003
      • Northeast Research Institute
    • Jacksonville, Florida, United States, 32216
      • Jacksonville Ctr For Clin Res
    • Miramar, Florida, United States, 33027
      • South Broward Research LLC
  • Georgia
    • Conyers, Georgia, United States, 30094
      • Hope Clin Res & Wellness
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
      • East West Med Res Inst
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
    • Skokie, Illinois, United States, 60077
      • Evanston Premier Hlthcr Res
    • Skokie, Illinois, United States, 60077
      • Endeavor Health
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Midwest Inst For Clin Res
  • Michigan
    • Buckley, Michigan, United States, 49620
      • Northern Pines Hlth Ctr, PC
  • Missouri
    • City of Saint Peters, Missouri, United States, 63303
      • StudyMetrix Research LLC
  • New York
    • New York, New York, United States, 10021
      • Comprehensive Weight Ctrl Prog
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • University of North Carolina
    • Greensboro, North Carolina, United States, 27408
      • PharmQuest Life Sciences LLC
    • Greensboro, North Carolina, United States, 27405
      • Medication Mgmnt, LLC_Grnsboro
    • Raleigh, North Carolina, United States, 27609
      • Accellacare_NC
    • Wilmington, North Carolina, United States, 28401
      • Accellacare
  • Ohio
    • Wadsworth, Ohio, United States, 44281
      • New Venture Medical Research
  • Oklahoma
    • Norman, Oklahoma, United States, 73072
      • Lynn Institute of Norman
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104-3317
      • The University of Penn Center
  • Rhode Island
    • Cumberland, Rhode Island, United States, 02864
      • Clinical Res Collaborative
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • North Charleston, South Carolina, United States, 29405
      • Coastal Carolina Res Ctr
    • Simpsonville, South Carolina, United States, 29681-1538
      • Hillcrest Clinical Research
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Research
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Holston Medical Group_Bristol
    • Kingsport, Tennessee, United States, 37660
      • Holston Medical Group
  • Texas
    • Amarillo, Texas, United States, 79124
      • Amarillo Med Spec LLP
    • Austin, Texas, United States, 78704
      • Elligo Clin Res Centre
    • Bellaire, Texas, United States, 77401
      • UT Health University of Texas
    • Dallas, Texas, United States, 75230
      • Velocity Clin Res, Dallas
    • Dallas, Texas, United States, 75226
      • Baylr Sctt White Rs Inst, Endo
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center-CRU
    • Longview, Texas, United States, 75605
      • DCOL Ctr for Clin Res
  • Virginia
    • Arlington, Virginia, United States, 22206
      • Washington Cntr Weight Mgmt
    • Newport News, Virginia, United States, 23606
      • Health Res of Hampton Roads
    • Richmond, Virginia, United States, 23294
      • National Clin Res Inc.
    • Winchester, Virginia, United States, 22601-3834
      • Selma Medical Associates
  • Washington
    • Olympia, Washington, United States, 98502
      • Capital Clin Res Ctr,LLC
    • Renton, Washington, United States, 98057
      • Rainier Clin Res Ctr Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Cagrilintide; Cagrilintide will be administered subcutaneously.; Drug: Semaglutide; Semaglutide will be administered subcutaneously.
Active Comparator: Tirzepatide 15 mg; Participants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 84 weeks.	Drug: Tirzepatide; Tirzepatide will be administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To confirm superiority of CagriSema versus tirzepatide: Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 84)
Achievement of greater than or equal to (≥) 25% weight reduction	Count of participants.	From baseline (week 0) to end of treatment (week 84)
Achievement of ≥ 30% weight reduction	Count of participants.	From baseline (week 0) to end of treatment (week 84)
Change in waist circumference	Measured in centimeter (cm).	From baseline (week 0) to end of treatment (week 84)
Change in systolic blood pressure (SBP)	Measured in millimeter of mercury (mmHg).	From baseline (week 0) to end of treatment (week 84)
Change in diastolic blood pressure (DBP)	Measured in mmHg.	From baseline (week 0) to end of treatment (week 84)
Relative change in lipids: Total cholesterol	Measured in percentage.	From baseline (week 0) to end of treatment (week 84)
Relative change in lipids: High-density lipoprotein (HDL) cholesterol	Measured in percentage.	From baseline (week 0) to end of treatment (week 84)
Relative change in lipids: Non-HDL cholesterol	Measured in percentage.	From baseline (week 0) to end of treatment (week 84)
Relative change in lipids: Low-density lipoprotein (LDL) cholesterol	Measured in percentage.	From baseline (week 0) to end of treatment (week 84)
Relative change in lipids: Very low-density lipoprotein (VLDL) cholesterol	Measured in percentage.	From baseline (week 0) to end of treatment (week 84)
Relative change in lipids: Triglycerides	Measured in percentage.	From baseline (week 0) to end of treatment (week 84)
Number of Treatment-emergent Adverse Events (TEAEs)	Count of events.	From baseline (week 0) to end of study (week 90)
Number of Treatment Emergent Serious adverse events (TESAEs)	Count of events.	From baseline (week 0) to end of study (week 90)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2023
• Primary Completion (Actual): December 8, 2025
• Study Completion (Actual): January 9, 2026

Study Registration Dates

• First Submitted: November 9, 2023
• First Submitted That Met QC Criteria: November 9, 2023
• First Posted (Actual): November 14, 2023

Study Record Updates

• Last Update Posted (Actual): February 6, 2026
• Last Update Submitted That Met QC Criteria: February 5, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide; semaglutide; cagrilintide
• Other Study ID Numbers: NN9838-7832; U1111-1292-4835 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No