Efficacy and safety of cagrilintide for weight management in participants with overweight or obesity

Conditions

Overweight and obesity

Brief summary

Relative change in body weight., Achievement of ≥ 5% body weight reduction.

Detailed description

Achievement of ≥ 10% body weight reduction., Achievement of ≥ 15% body weight reduction., Change in waist circumference., Ratio to baseline in triglycerides., Ratio to baseline in hsCRP., Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score., Change in body weight., Change in SF-36v2® Health Survey Acute (SF-36v2® Acute) physical component summary score., Change in SF-36v2® mental component summary score., Change in IWQOL-Lite-CT total score., Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score., Change in systolic blood pressure., Change in diastolic blood pressure., Ratio to baseline of: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Free fatty acids CCI CCI, Change in glycated haemoglobin (HbA1c)., Change in fasting plasma glucose., Ratio to baseline in fasting serum insulin., Number of treatment emergent adverse events., Number of treatment emergent serious adverse events.

Related papers

No related papers found yet.

Interventions

DRUGcagrilintide

DRUGPlacebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Relative change in body weight., Achievement of ≥ 5% body weight reduction.	—

Secondary

Measure	Time frame
Achievement of ≥ 10% body weight reduction., Achievement of ≥ 15% body weight reduction., Change in waist circumference., Ratio to baseline in triglycerides., Ratio to baseline in hsCRP., Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score., Change in body weight., Change in SF-36v2® Health Survey Acute (SF-36v2® Acute) physical component summary score., Change in SF-36v2® mental component summary score., Change in IWQOL-Lite-CT total score., Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score., Change in systolic blood pressure., Change in diastolic blood pressure., Ratio to baseline of: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Free fatty acids CCI CCI, Change in glycated haemoglobin (HbA1c)., Change in fasting plasma glucose., Ratio to baseline i	—

Measure

Time frame

Achievement of ≥ 10% body weight reduction., Achievement of ≥ 15% body weight reduction., Change in waist circumference., Ratio to baseline in triglycerides., Ratio to baseline in hsCRP., Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score., Change in body weight., Change in SF-36v2® Health Survey Acute (SF-36v2® Acute) physical component summary score., Change in SF-36v2® mental component summary score., Change in IWQOL-Lite-CT total score., Achievement of at least 14.6-point increase (yes/no) in IWQOL-Lite-CT Physical Function score., Change in systolic blood pressure., Change in diastolic blood pressure., Ratio to baseline of: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Free fatty acids CCI CCI, Change in glycated haemoglobin (HbA1c)., Change in fasting plasma glucose., Ratio to baseline i

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Countries

France, Germany, Italy, Norway, Poland

Outcome results

None listed