Efficacy and safety of cagrilintide s.c. in combination with semaglutide s.c. (CagriSema s.c.) once-weekly in participants with overweight or obesity and type 2 diabetes

Conditions

Overweight and obesity and type 2 diabetes

Brief summary

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

Detailed description

Achievement of ≥ 20% weight reduction, Relative change in body weight, Change in waist circumference, Change in Glycated Haemoglobin (HbA1c), Change in Systolic Blood Pressure (SBP), Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score, Change in SF-v2 Health Survey Acute (SF-36v2 Acute) Physical Functioning score, Number of Treatment Emergent Adverse Events (TEAEs), Number of Treatment Emergent Serious adverse events (TESAEs), Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter), Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

Related papers

No related papers found yet.

Interventions

DRUGcagrilintide semaglutide

DRUGPlacebo + Placebo

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
Achievement of ≥ 20% weight reduction, Relative change in body weight, Change in waist circumference, Change in Glycated Haemoglobin (HbA1c), Change in Systolic Blood Pressure (SBP), Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score, Change in SF-v2 Health Survey Acute (SF-36v2 Acute) Physical Functioning score, Number of Treatment Emergent Adverse Events (TEAEs), Number of Treatment Emergent Serious adverse events (TESAEs), Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter), Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold	—

Measure

Time frame

Achievement of ≥ 20% weight reduction, Relative change in body weight, Change in waist circumference, Change in Glycated Haemoglobin (HbA1c), Change in Systolic Blood Pressure (SBP), Change in Impact of Weight on Quality Of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score, Change in SF-v2 Health Survey Acute (SF-36v2 Acute) Physical Functioning score, Number of Treatment Emergent Adverse Events (TEAEs), Number of Treatment Emergent Serious adverse events (TESAEs), Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter), Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold

—

Countries

Austria, Germany, Hungary, Ireland, Poland

Outcome results

None listed