Clinical trial NCT06131437: A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-11-14
Enrollment: 809
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 84)
Secondary outcomes:
measure: To confirm superiority of CagriSema versus tirzepatide: Relative change in body weight
timeFrame: From baseline (week 0) to end of treatment (week 84)
measure: Achievement of greater than or equal to (≥) 25% weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 84)
measure: Achievement of ≥ 30% weight reduction
timeFrame: From baseline (week 0) to end of treatment (week 84)
measure: Change in waist circumference
timeFrame: From baseline (week 0) to end of treatment (week 84)
measure: Change in systolic blood pressure (SBP)
timeFrame: From baseline (week 0) to end of treatment (week 84)
measure: Change in diastolic blood pressure (DBP)
timeFrame: From baseline (week 0) to end of treatment (week 84)
measure: Relative change in lipids: Total cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 84)
measure: Relative change in lipids: High-density lipoprotein (HDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 84)
measure: Relative change in lipids: Non-HDL cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 84)
measure: Relative change in lipids: Low-density lipoprotein (LDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 84)
measure: Relative change in lipids: Very low-density lipoprotein (VLDL) cholesterol
timeFrame: From baseline (week 0) to end of treatment (week 84)
measure: Relative change in lipids: Triglycerides
timeFrame: From baseline (week 0) to end of treatment (week 84)
measure: Number of Treatment-emergent Adverse Events (TEAEs)
timeFrame: From baseline (week 0) to end of study (week 90)
measure: Number of Treatment Emergent Serious adverse events (TESAEs)
timeFrame: From baseline (week 0) to end of study (week 90)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama Birmingham
state: Alabama
city: Montgomery
country: United States
facility: Chambliss Clinical Trials LLC
state: Alabama
city: Costa Mesa
country: United States
facility: FDRC
state: California
city: Walnut Creek
country: United States
facility: Diablo Clinical Research, Inc.
state: California
city: Aurora
country: United States
facility: Univ of Colorado at Denver
state: Colorado
city: Fleming Island
country: United States
facility: Northeast Research Institute
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Ctr For Clin Res
state: Florida
city: Miramar
country: United States
facility: South Broward Research LLC
state: Florida
city: Conyers
country: United States
facility: Hope Clin Res & Wellness
state: Georgia
city: Honolulu
country: United States
facility: East West Med Res Inst
state: Hawaii
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Skokie
country: United States
facility: Endeavor Health
state: Illinois
city: Skokie
country: United States
facility: Evanston Premier Hlthcr Res
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Inst For Clin Res
state: Indiana
city: Buckley
country: United States
facility: Northern Pines Hlth Ctr, PC
state: Michigan
city: Saint Peters
country: United States
facility: StudyMetrix Research LLC
state: Missouri
city: New York
country: United States
facility: Comprehensive Weight Ctrl Prog
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Greensboro
country: United States
facility: Medication Mgmnt, LLC_Grnsboro
state: North Carolina
city: Greensboro
country: United States
facility: PharmQuest Life Sciences LLC
state: North Carolina
city: Raleigh
country: United States
facility: Accellacare_NC
state: North Carolina
city: Wilmington
country: United States
facility: Accellacare
state: North Carolina
city: Wadsworth
country: United States
facility: New Venture Medical Research
state: Ohio
city: Norman
country: United States
facility: Lynn Institute of Norman
state: Oklahoma
city: Philadelphia
country: United States
facility: The University of Penn Center
state: Pennsylvania
city: Cumberland
country: United States
facility: Clinical Res Collaborative
state: Rhode Island
city: Charleston
country: United States
facility: Medical University Of South Carolina
state: South Carolina
city: North Charleston
country: United States
facility: Coastal Carolina Res Ctr
state: South Carolina
city: Simpsonville
country: United States
facility: Hillcrest Clinical Research
state: South Carolina
city: Spartanburg
country: United States
facility: Spartanburg Medical Research
state: South Carolina
city: Bristol
country: United States
facility: Holston Medical Group_Bristol
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Amarillo
country: United States
facility: Amarillo Med Spec LLP
state: Texas
city: Austin
country: United States
facility: Elligo Clin Res Centre
state: Texas
city: Bellaire
country: United States
facility: UT Health University of Texas
state: Texas
city: Dallas
country: United States
facility: Baylr Sctt White Rs Inst, Endo
state: Texas
city: Dallas
country: United States
facility: Velocity Clin Res, Dallas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center-CRU
state: Texas
city: Longview
country: United States
facility: DCOL Ctr for Clin Res
state: Texas
city: Arlington
country: United States
facility: Washington Cntr Weight Mgmt
state: Virginia
city: Newport News
country: United States
facility: Health Res of Hampton Roads
state: Virginia
city: Richmond
country: United States
facility: National Clin Res Inc.
state: Virginia
city: Winchester
country: United States
facility: Selma Medical Associates
state: Virginia
city: Olympia
country: United States
facility: Capital Clin Res Ctr,LLC
state: Washington
city: Renton
country: United States
facility: Rainier Clin Res Ctr Inc
state: Washington
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References: