Efficacy and safety of NNC0487-0111s.c once weekly in participants with obesity who have reached target dose during run-in period (AMAZE12).

Conditions

Obesity

Brief summary

Relative change in body weight

Detailed description

Relative change in body weight, CCI, CCI, CCI, Change in waist circumference, 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-36v2® Health Survey Acute (SF-36v2 Acute) Physical functioning score, Change in body weight, Change in body mass index (BMI), CCI, Change in glycated haemoglobin (HbA1c), Change in fasting plasma glucose (FPG), Change in fasting insulin, Change in diastolic blood pressure (DBP), Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglycerides, Change in high-sensitivity C-reactive protein (hsCRP), Change in IWQOL-Lite-CT: Physical composite score Psychosocial composite score Total score, CCI, Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs) TEAEs leading to permanent treatment discontinuation

Related papers

No related papers found yet.

Papers published before 2002-11-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGNNC0487-0111 B 10142

DRUGNNC0487-0111 B 10143

DRUGNNC0487-0111 B 10141

DRUGNNC0487-0111 B 10145

DRUGPlacebo

DRUGNNC0487-0111 B 10146

DRUGNNC0487-0111 B 10144

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Relative change in body weight	—

Secondary

Measure	Time frame
Relative change in body weight, CCI, CCI, CCI, Change in waist circumference, 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-36v2® Health Survey Acute (SF-36v2 Acute) Physical functioning score, Change in body weight, Change in body mass index (BMI), CCI, Change in glycated haemoglobin (HbA1c), Change in fasting plasma glucose (FPG), Change in fasting insulin, Change in diastolic blood pressure (DBP), Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglycerides, Change in high-sensitivity C-reactive protein (hsCRP), Change in IWQOL-Lite-CT: Physical composite score Psychosocial composite score Total score, CCI, Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs)	—

Measure

Time frame

Relative change in body weight, CCI, CCI, CCI, Change in waist circumference, 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-36v2® Health Survey Acute (SF-36v2 Acute) Physical functioning score, Change in body weight, Change in body mass index (BMI), CCI, Change in glycated haemoglobin (HbA1c), Change in fasting plasma glucose (FPG), Change in fasting insulin, Change in diastolic blood pressure (DBP), Change in lipids: Total cholesterol High-density lipoprotein (HDL) cholesterol Low-density lipoprotein (LDL) cholesterol Very low-density lipoprotein (VLDL) cholesterol Non-HDL cholesterol Triglycerides, Change in high-sensitivity C-reactive protein (hsCRP), Change in IWQOL-Lite-CT: Physical composite score Psychosocial composite score Total score, CCI, Number of: Treatment Emergent Adverse Events (TEAEs) Treatment Emergent Serious Adverse Events (TESAEs)

—

Outcome results

None listed