A clinical study to compare efficacy and safety of two different doses of CagriSema and semaglutide in participants with obesity with or without type 2 diabetes

Conditions

Participants with obesity with or without type 2 diabetes

Brief summary

Relative change in body weight

Detailed description

Relative change in body weight, Change in BMI, Achievement of ≥30% weight reduction, Achievement of ≥25% weight reduction, Change in waist circumference, Mean change in body weight, Achievement of ≥20% weight reduction, Achievement of BMI < 30 kg/m2, Achievement of BMI < 27 kg/m2, Achievement of normal BMI (18.5 ≤ BMI < 25), Achievement of waist-to-height ratio of < 0.53, CCI, Ratio to baseline of Total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, Triglycerides, Free fatty acids and Non-HDL cholesterol, Change in SF-36v2 physical function, Change in IWQOL-Lite-CT physical function, Achievement of ≥20% weight reduction (Sub-study 2 only), Change in HbA1c, Achievement of HbA1c < 6.5% (only Sub-study 2), Achievement of normal HbA1c < 5.7%, Number of TEAEs, Number of TESAEs, CCI

Related papers

No related papers found yet.

Interventions

DRUGsemaglutide

DRUGcagrilintide semaglutide

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Relative change in body weight	—

Secondary

Measure	Time frame
Relative change in body weight, Change in BMI, Achievement of ≥30% weight reduction, Achievement of ≥25% weight reduction, Change in waist circumference, Mean change in body weight, Achievement of ≥20% weight reduction, Achievement of BMI < 30 kg/m2, Achievement of BMI < 27 kg/m2, Achievement of normal BMI (18.5 ≤ BMI < 25), Achievement of waist-to-height ratio of < 0.53, CCI, Ratio to baseline of Total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, Triglycerides, Free fatty acids and Non-HDL cholesterol, Change in SF-36v2 physical function, Change in IWQOL-Lite-CT physical function, Achievement of ≥20% weight reduction (Sub-study 2 only), Change in HbA1c, Achievement of HbA1c < 6.5% (only Sub-study 2), Achievement of normal HbA1c < 5.7%, Number of TEAEs, Number of TESAEs, CCI	—

Measure

Time frame

Relative change in body weight, Change in BMI, Achievement of ≥30% weight reduction, Achievement of ≥25% weight reduction, Change in waist circumference, Mean change in body weight, Achievement of ≥20% weight reduction, Achievement of BMI < 30 kg/m2, Achievement of BMI < 27 kg/m2, Achievement of normal BMI (18.5 ≤ BMI < 25), Achievement of waist-to-height ratio of < 0.53, CCI, Ratio to baseline of Total cholesterol, HDL cholesterol, LDL cholesterol, VLDL cholesterol, Triglycerides, Free fatty acids and Non-HDL cholesterol, Change in SF-36v2 physical function, Change in IWQOL-Lite-CT physical function, Achievement of ≥20% weight reduction (Sub-study 2 only), Change in HbA1c, Achievement of HbA1c < 6.5% (only Sub-study 2), Achievement of normal HbA1c < 5.7%, Number of TEAEs, Number of TESAEs, CCI

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Outcome results

None listed