Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide
- Conditions
- ObesityOverweight
- Interventions
- Drug: Placebo
- Registration Number
- NCT07220642
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study will look at how much cagrilintide helps people with overweight or obesity lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participants will either get cagrilintide or placebo. Which treatment participants get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. Possible side effects will be followed carefully during the study. For each participant, the study will last for about 1 year and 6 months.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 300
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cagrilintide Cagrilintide Participants will receive cagrilintide subcutaneously once weekly for 64 weeks. Placebo Placebo Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks.
- Primary Outcome Measures
Name Time Method Relative change in body weight From baseline (week 0) to end of treatment (week 64) Measured as percentage (%) of body weight.
Number of participants with achievement of greater than or equals (>=) 5 percent (%) body weight reduction From baseline (week 0) to end of treatment (week 64) Measured as count of participants.
- Secondary Outcome Measures
Name Time Method Number of participants with achievement of >= 10 % body weight reduction From baseline (week 0) to end of treatment (week 64) Measured as count of participants.
Number of participants with achievement of >= 15 % body weight reduction From baseline (week 0) to end of treatment (week 64) Measured as count of participants.
Change in waist circumference From baseline (week 0) to end of treatment (week 64) Measured as centimeter (cm).
Ratio to baseline in triglycerides From baseline (week 0) to end of treatment (week 64) Measured as ratio.
Ratio to baseline in high sensitivity C-Reactive Protein (hsCRP) From baseline (week 0) to end of treatment (week 64) Measured as ratio.
Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score From baseline (week 0) to end of treatment (week 64) Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.
Change in body weight From baseline (week 0) to end of treatment (week 64) Measured as kilogram (kg).
Change in SF-36v2® Health Survey Acute (SF-36v2® Acute) physical component summary score From baseline (week 0) to end of treatment (week 64) Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The physical component summary score ranges from 6.1 to 79.7.
Change in SF-36v2® mental component summary score From baseline (week 0) to end of treatment (week 64) Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The mental component summary score ranges from -3.8 to 78.7.
Change in IWQOL-Lite-CT total score From baseline (week 0) to end of treatment (week 64) Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The total score ranges from 0-100.
Number of participants with achievement of at least 14.6-point increase in IWQOL-Lite-CT Physical Function score (yes/no) From baseline (week 0) to end of treatment (week 64) Measured as count of participants. IWQOL-Lite-CT measures weight related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.
Change in Systolic Blood Pressure (SBP) From baseline (week 0) to end of treatment (week 64) Measured as millimeter of mercury (mmHg).
Change in Diastolic Blood Pressure (DBP) From baseline (week 0) to end of treatment (week 64) Measured as mmHg.
Ratio to baseline of total cholesterol From baseline (week 0) to end of treatment (week 64) Measured as ratio.
Ratio to baseline of High-Density Lipoprotein (HDL) cholesterol From baseline (week 0) to end of treatment (week 64) Measured as ratio.
Ratio to baseline of Low-Density Lipoprotein (LDL) cholesterol From baseline (week 0) to end of treatment (week 64) Measured as ratio.
Ratio to baseline of Very Low-Density Lipoprotein (VLDL) cholesterol From baseline (week 0) to end of treatment (week 64) Measured as ratio.
Ratio to baseline of non-HDL cholesterol From baseline (week 0) to end of treatment (week 64) Measured as ratio.
Ratio to baseline of free fatty acids From baseline (week 0) to end of treatment (week 64) Measured as ratio.
Change in glycated haemoglobin (HbA1c) percentage-points (%-points) From baseline (week 0) to end of treatment (week 64) Measured as %-points.
Change in HbA1c millimoles per mole (mmol/mol) From baseline (week 0) to end of treatment (week 64) Measured as mmol/mol.
Change in Fasting Plasma Glucose (FPG) millimoles per litre (mmol/L) From baseline (week 0) to end of treatment (week 64) Measured as mmol/L.
Change in FPG milligrams per deciliter (mg/dL) From baseline (week 0) to end of treatment (week 64) Measured as mg/dL.
Ratio to baseline in fasting serum insulin From baseline (week 0) to end of treatment (week 64) Measured as ratio.
Number of treatment emergent adverse events (TEAEs) From baseline (week 0) to end of study (week 71) Measured as count of events.
Number of treatment emergent serious adverse events (TESAEs) From baseline (week 0) to end of study (week 71) Measured as count of events.
Trial Locations
- Locations (40)
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Univ of Colorado at Denver
🇺🇸Aurora, Colorado, United States
Florida Inst For Clin Res LLC
🇺🇸Orlando, Florida, United States
Oviedo Medical Research, LLC
🇺🇸Oviedo, Florida, United States
Walgreens - Store 11760
🇺🇸Oak Park, Illinois, United States
Midwest Inst For Clin Res
🇺🇸Indianapolis, Indiana, United States
StudyMetrix Research LLC
🇺🇸City of Saint Peters, Missouri, United States
PharmQuest Life Sciences LLC
🇺🇸Greensboro, North Carolina, United States
Selma Medical Associates
🇺🇸Winchester, Virginia, United States
CIPREC Pueyrredon
🇦🇷Buenos Aires, Argentina
Scroll for more (30 remaining)Diablo Clinical Research, Inc.🇺🇸Walnut Creek, California, United States