A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight
- Conditions
- Obesity
- Interventions
- Registration Number
- NCT06131437
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 809
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CagriSema 2.4 mg/2.4 mg Cagrilintide 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. CagriSema 2.4 mg/2.4 mg Semaglutide 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. Tirzepatide 15 mg Tirzepatide Participants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 84 weeks.
- Primary Outcome Measures
Name Time Method To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight From baseline (week 0) to end of treatment (week 84) Measured in percentage (%).
- Secondary Outcome Measures
Name Time Method To confirm superiority of CagriSema versus tirzepatide: Relative change in body weight From baseline (week 0) to end of treatment (week 84) Measured in percentage (%).
Achievement of greater than or equal to (≥) 25% weight reduction From baseline (week 0) to end of treatment (week 84) Count of participants.
Achievement of ≥ 30% weight reduction From baseline (week 0) to end of treatment (week 84) Count of participants.
Change in waist circumference From baseline (week 0) to end of treatment (week 84) Measured in centimeter (cm).
Change in systolic blood pressure (SBP) From baseline (week 0) to end of treatment (week 84) Measured in millimeter of mercury (mmHg).
Change in diastolic blood pressure (DBP) From baseline (week 0) to end of treatment (week 84) Measured in mmHg.
Relative change in lipids: Total cholesterol From baseline (week 0) to end of treatment (week 84) Measured in percentage.
Relative change in lipids: High-density lipoprotein (HDL) cholesterol From baseline (week 0) to end of treatment (week 84) Measured in percentage.
Relative change in lipids: Non-HDL cholesterol From baseline (week 0) to end of treatment (week 84) Measured in percentage.
Relative change in lipids: Low-density lipoprotein (LDL) cholesterol From baseline (week 0) to end of treatment (week 84) Measured in percentage.
Relative change in lipids: Very low-density lipoprotein (VLDL) cholesterol From baseline (week 0) to end of treatment (week 84) Measured in percentage.
Relative change in lipids: Triglycerides From baseline (week 0) to end of treatment (week 84) Measured in percentage.
Number of Treatment-emergent Adverse Events (TEAEs) From baseline (week 0) to end of study (week 90) Count of events.
Number of Treatment Emergent Serious adverse events (TESAEs) From baseline (week 0) to end of study (week 90) Count of events.
Trial Locations
- Locations (45)
Univ of Alabama Birmingham
🇺🇸Birmingham, Alabama, United States
Chambliss Clinical Trials LLC
🇺🇸Montgomery, Alabama, United States
FDRC
🇺🇸Costa Mesa, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Univ of Colorado at Denver
🇺🇸Aurora, Colorado, United States
Northeast Research Institute
🇺🇸Fleming Island, Florida, United States
Jacksonville Ctr For Clin Res
🇺🇸Jacksonville, Florida, United States
South Broward Research LLC
🇺🇸Miramar, Florida, United States
Hope Clin Res & Wellness
🇺🇸Conyers, Georgia, United States
East West Med Res Inst
🇺🇸Honolulu, Hawaii, United States
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