A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight
- Conditions
- Obesity
- Interventions
- Registration Number
- NCT06388187
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 300
-
Male or female
-
Age above or equal to 18 years at the time of signing informed consent
- Body Mass index (BMI) greater than or equal to (≥) 30.0 kilogram per meter square (kg/m^2) or
- BMI ≥27.0 kg/m2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CagriSema Dose 2 Semaglutide Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 12-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 56 weeks. Placebo Dose 2 Placebo Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 68 weeks. CagriSema Dose 1 Semaglutide Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 60 weeks. Placebo Dose 1 Placebo Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 68 weeks. CagriSema Dose 1 Cagrilintide Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 60 weeks. CagriSema Dose 2 Cagrilintide Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 12-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 56 weeks.
- Primary Outcome Measures
Name Time Method Relative change in body weight From baseline (week 0) to end of treatment (week 68) Measured in percentage (%).
Achievement of ≥5% weight reduction From baseline (week 0) to end of treatment (week 68) Measured as count of participant.
- Secondary Outcome Measures
Name Time Method Achievement of ≥20% weight reduction From baseline (week 0) to end of treatment (week 68) Measured as count of participant.
Change in waist circumference From baseline (week 0) to end of treatment (week 68) Measured in centimeter (cm).
Change in systolic blood pressure From baseline (week 0) to end of treatment (week 68) Measured in millimeters of mercury.
Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol From baseline (week 0) to end of treatment (week 68) Measured in ratio.
Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol From baseline (week 0) to end of treatment (week 68) Measured in ratio.
Ratio to baseline in lipids: Triglycerides From baseline (week 0) to end of treatment (week 68) Measured in ratio.
Ratio to baseline in lipids: Free fatty acids From baseline (week 0) to end of treatment (week 68) Measured in ratio.
Number of treatment emergent adverse events (TEAEs) From baseline (week 0) to end of study (week 74) Measured as count of events.
Number of treatment emergent serious adverse events (TESAEs) From baseline (week 0) to end of study (week 74) Measured as count of events.
Achievement of ≥10% weight reduction From baseline (week 0) to end of treatment (week 68) Measured as count of participant.
Achievement of ≥15% weight reduction From baseline (week 0) to end of treatment (week 68) Measured as count of participant.
Ratio to baseline in lipids: Total cholesterol From baseline (week 0) to end of treatment (week 68) Measured in ratio.
Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol From baseline (week 0) to end of treatment (week 68) Measured in ratio.
Trial Locations
- Locations (24)
Aurora FDRC Inc.
🇺🇸Costa Mesa, California, United States
Clinical Trial Res Assoc,Inc
🇺🇸Plantation, Florida, United States
Midwest Inst For Clin Res
🇺🇸Indianapolis, Indiana, United States
Accellacare
🇺🇸Wilmington, North Carolina, United States
Velocity Clinical Res-Dallas
🇺🇸Dallas, Texas, United States
Washington Cntr Weight Mgmt
🇺🇸Arlington, Virginia, United States
Capital Clin Res Ctr,LLC
🇺🇸Olympia, Washington, United States
Ocean West Research Clinic
🇨🇦Surrey, British Columbia, Canada
Nova Scotia Health Authority
🇨🇦Halifax, Nova Scotia, Canada
Wharton Med Clin Trials
🇨🇦Hamilton, Ontario, Canada
Scroll for more (14 remaining)Aurora FDRC Inc.🇺🇸Costa Mesa, California, United States