A Phase 2 Randomized, Placebo-controlled, Double-blind, Dose-ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AMG 133 in Adult Subjects With Overweight or Obesity, With or Without Type 2 Diabetes Mellitus.

Conditions

Overweight and Obesity

Brief summary

Percent change from baseline to week 52 in body weight

Detailed description

Achieving ≥ 5%, ≥ 10%, ≥ 15%, ≥ 20% reduction in body weight from baseline at week 52 (yes/no), Change from baseline to week 52 in hemoglobin A1c (HbA1c), in fasting serum insulin, in fasting plasma glucose, in Homeostasis Model Assessment for insulin resistance (HOMA2-IR), in Homeostasis Model Assessment for steady state beta cell function (HOMA2-%B), PK parameters for AMG 133 including, but not limited to maximum observed plasma concentration (Cmax), and area under the concentration-time curve (AUC), Change from baseline to week 52 in waist circumference, in body weight, in SBP, in DBP, in BMI, in body composition (eg, fat mass, lean mass) using dual-energy X-ray absorptiometry (DXA) for a subset of subjects, Percent change from baseline to week 52 in high-sensitivity C-reactive protein (hs-CRP), in low-density lipoprotein cholesterol (LDL-C), in total cholesterol, in high-density lipoprotein cholesterol (HDL-C), in non-HDL-C, in very-low-density lipoprotein cholesterol (VLDL-C), in triglycerides, in free fatty acids (FFA)

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGAMG 133

DRUGPlacebo for AMG 133

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percent change from baseline to week 52 in body weight	—

Secondary

Measure	Time frame
Achieving ≥ 5%, ≥ 10%, ≥ 15%, ≥ 20% reduction in body weight from baseline at week 52 (yes/no), Change from baseline to week 52 in hemoglobin A1c (HbA1c), in fasting serum insulin, in fasting plasma glucose, in Homeostasis Model Assessment for insulin resistance (HOMA2-IR), in Homeostasis Model Assessment for steady state beta cell function (HOMA2-%B), PK parameters for AMG 133 including, but not limited to maximum observed plasma concentration (Cmax), and area under the concentration-time curve (AUC), Change from baseline to week 52 in waist circumference, in body weight, in SBP, in DBP, in BMI, in body composition (eg, fat mass, lean mass) using dual-energy X-ray absorptiometry (DXA) for a subset of subjects, Percent change from baseline to week 52 in high-sensitivity C-reactive protein (hs-CRP), in low-density lipoprotein cholesterol (LDL-C), in total cholesterol, in high-density lipoprotein cholesterol (HDL-C), in non-HDL-C, in very-low-density lipoprotein cholesterol (VLDL-C), in	—

Measure

Time frame

Achieving ≥ 5%, ≥ 10%, ≥ 15%, ≥ 20% reduction in body weight from baseline at week 52 (yes/no), Change from baseline to week 52 in hemoglobin A1c (HbA1c), in fasting serum insulin, in fasting plasma glucose, in Homeostasis Model Assessment for insulin resistance (HOMA2-IR), in Homeostasis Model Assessment for steady state beta cell function (HOMA2-%B), PK parameters for AMG 133 including, but not limited to maximum observed plasma concentration (Cmax), and area under the concentration-time curve (AUC), Change from baseline to week 52 in waist circumference, in body weight, in SBP, in DBP, in BMI, in body composition (eg, fat mass, lean mass) using dual-energy X-ray absorptiometry (DXA) for a subset of subjects, Percent change from baseline to week 52 in high-sensitivity C-reactive protein (hs-CRP), in low-density lipoprotein cholesterol (LDL-C), in total cholesterol, in high-density lipoprotein cholesterol (HDL-C), in non-HDL-C, in very-low-density lipoprotein cholesterol (VLDL-C), in

—

Countries

Czechia, Germany, Hungary, Poland, Spain

Outcome results

None listed