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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06131437
• Other study ID #: NN9838-7832
• Secondary ID: U1111-1292-4835
• Status: Recruiting
• Phase: Phase 3
• Start date: November 27, 2023
• Est. completion date: October 21, 2025

Study information

• Verified date: June 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: October 21, 2025
• Est. primary completion date: August 27, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Cagrilintide
Cagrilintide will be administered subcutaneously.
• Semaglutide
Semaglutide will be administered subcutaneously.
• Tirzepatide
Tirzepatide will be administered subcutaneously.

Locations

Country	Name	City	State
United States	Amarillo Med Spec LLP	Amarillo	Texas
United States	Washington Cntr Weight Mgmt	Arlington	Virginia
United States	Univ of Colorado at Denver	Aurora	Colorado
United States	Elligo Clin Res Centre	Austin	Texas
United States	UT Health University of Texas	Bellaire	Texas
United States	Univ of Alabama Birmingham	Birmingham	Alabama
United States	Univ of Alabama Birmingham	Birmingham	Alabama
United States	Holston Medical Group_Bristol	Bristol	Tennessee
United States	Northern Pines Hlth Ctr, PC	Buckley	Michigan
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Medical University Of South Carolina	Charleston	South Carolina
United States	Great Lakes Clinical Trials	Chicago	Illinois
United States	Hope Clin Res & Wellness	Conyers	Georgia
United States	FDRC	Costa Mesa	California
United States	Clinical Res Collaborative	Cumberland	Rhode Island
United States	Baylr Sctt White Rs Inst, Endo	Dallas	Texas
United States	UT Southwestern Medical Center-CRU	Dallas	Texas
United States	Velocity Clin Res, Dallas	Dallas	Texas
United States	Northeast Research Institute	Fleming Island	Florida
United States	Medication Mgmnt, LLC_Grnsboro	Greensboro	North Carolina
United States	PharmQuest Life Sciences LLC	Greensboro	North Carolina
United States	East West Med Res Inst	Honolulu	Hawaii
United States	Midwest Inst For Clin Res	Indianapolis	Indiana
United States	Jacksonville Ctr For Clin Res	Jacksonville	Florida
United States	Holston Medical Group	Kingsport	Tennessee
United States	DCOL Ctr for Clin Res	Longview	Texas
United States	South Broward Research LLC	Miramar	Florida
United States	Chambliss Clinical Trials LLC	Montgomery	Alabama
United States	Yale University School Of Medicine	New Haven	Connecticut
United States	Comprehensive Weight Ctrl Prog	New York	New York
United States	Comprehensive Weight Ctrl Prog	New York	New York
United States	Health Res of Hampton Roads	Newport News	Virginia
United States	Lynn Institute of Norman	Norman	Oklahoma
United States	Coastal Carolina Res Ctr	North Charleston	South Carolina
United States	Capital Clin Res Ctr,LLC	Olympia	Washington
United States	The University of Penn Center	Philadelphia	Pennsylvania
United States	Accellacare_NC	Raleigh	North Carolina
United States	Rainier Clin Res Ctr Inc	Renton	Washington
United States	National Clin Res Inc.	Richmond	Virginia
United States	StudyMetrix Research LLC	Saint Peters	Missouri
United States	Hillcrest Clinical Research	Simpsonville	South Carolina
United States	Evanston Premier Hlthcr Res	Skokie	Illinois
United States	NorthShore Univ Hlth Sys	Skokie	Illinois
United States	Spartanburg Medical Research	Spartanburg	South Carolina
United States	New Venture Medical Research	Wadsworth	Ohio
United States	Diablo Clinical Research, Inc.	Walnut Creek	California
United States	Accellacare	Wilmington	North Carolina
United States	Selma Medical Associates	Winchester	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 72)
Secondary	Achievement of greater than or equal to (=) 25% weight reduction	Count of participant.	From baseline (week 0) to end of treatment (week 72)
Secondary	Achievement of = 30% weight reduction	Count of participant.	From baseline (week 0) to end of treatment (week 72)
Secondary	Change in waist circumference	Measured in centimeter (cm).	From baseline (week 0) to end of treatment (week 72)
Secondary	Change in systolic blood pressure (SBP)	Measured in millimeter of mercury (mmHg).	From baseline (week 0) to end of treatment (week 72)
Secondary	Change in diastolic blood pressure (DBP)	Measured in mmHg.	From baseline (week 0) to end of treatment (week 72)
Secondary	Relative change in lipids: Total cholesterol	Measured in percentage.	From baseline (week 0) to end of treatment (week 72)
Secondary	Relative change in lipids: High-density lipoprotein (HDL) cholesterol	Measured in percentage.	From baseline (week 0) to end of treatment (week 72)
Secondary	Relative change in lipids: Non-HDL cholesterol	Measured in percentage.	From baseline (week 0) to end of treatment (week 72)
Secondary	Relative change in lipids: Low-density lipoprotein (LDL) cholesterol	Measured in percentage.	From baseline (week 0) to end of treatment (week 72)
Secondary	Relative change in lipids: Very low-density lipoprotein (VLDL) cholesterol	Measured in percentage.	From baseline (week 0) to end of treatment (week 72)
Secondary	Relative change in lipids: Triglycerides	Measured in percentage.	From baseline (week 0) to end of treatment (week 72)
Secondary	Number of Treatment-emergent Adverse Events (TEAEs)	Count of events.	From baseline (week 0) to end of study (week 78)
Secondary	Number of Treatment Emergent Serious adverse events (TESAEs)	Count of events.	From baseline (week 0) to end of study (week 78)