2023-510470-13-00已完成2 期
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.
Amgen Inc.19 个研究点 分布在 5 个国家目标入组 135 人开始时间: 2023年3月13日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 135
- 试验地点
- 19
- 主要终点
- Percent change from baseline to week 52 in body weight
研究概览
简要总结
To compare and assess the dose response of 3 selected doses of AMG 133 compared with placebo, on inducing and maintaining weight loss from baseline at week 52 in subjects with overweight or obesity without diabetes mellitus (cohort A) and in subjects with overweight or obesity with type 2 diabetes mellitus (cohort B)
研究设计
- 分配方式
- Randomized
- 主要目的
- Part 2 Group 3
- 盲法
- Double (Subject, Analyst, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Subject has provided informed consent prior to initiation of any study-specific activities/procedures.
- •Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years).
- •Subject has a BMI ≥ 27 kg/sq.m at screening
- •Subject has had at least 1 unsuccessful attempt at weight loss by diet and exercise in the opinion of the investigator.
- •For subjects in cohort A only, presence of at least 1 of the following weight-related complications: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease; or BMI ≥ 30 kg/sq.m
- •For subjects in cohort A only, HbA1c < 6.5% (< 48 mmol/mol) at screening without a diagnosis of type 1 or 2 diabetes mellitus.
- •For subjects in cohort B only, HbA1c ≥ 7% and ≤ 10% (53 to 86 mmol/mol) at screening with an established diagnosis of type 2 diabetes mellitus for ≥ 180 days prior to screening.
- •For subjects in cohort B only, either treated with diet and exercise alone or on stable (at least 90 days prior to screening) treatment with metformin, a sulfonylurea, or a sodium-glucose cotransporter 2 (SGLT2) inhibitor as monotherapy or combination therapy, per approved local label.
排除标准
- •Subjects with type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except type 2 diabetes mellitus (for cohort B only).
- •History of proliferative diabetic retinopathy, diabetic macular edema, or nonproliferative diabetic retinopathy that requires acute treatment.
- •For the subjects in the DXA substudy only, body weight greater than the local DXA scanner capacity at screening.
- •Change in body weight > 5 kg within 90 days before screening per subject report or medical records.
- •For subjects in cohort B only, fasting glucose > 270 mg/dL (15.0 mmol/L) at screening.
- •Any of the following within the last 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure; or currently have New York Health Association Class III or IV heart failure.
- •Uncontrolled thyroid disease, defined as TSH > 6.0 mIU/L or < 0.4 mIU/L as measured by central laboratory at screening. Subjects who received treatment for hypothyroidism are permitted in the study, if their thyroid hormone replacement dose has been stable for at least 90 days and their TSH at screening is within the above range.
- •A corrected QT interval (QTc) of > 450 msec in males or > 470 msec in females at screening as assessed by the investigator, or history of long QT syndrome
研究组 & 干预措施
AMG 133
Test
干预措施: AMG 133 (Drug)
Placebo for AMG 133
Placebo
干预措施: Placebo for AMG 133 (Drug)
结局指标
主要结局
Percent change from baseline to week 52 in body weight
Percent change from baseline to week 52 in body weight
次要结局
- 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)
研究者
Medical Information
Scientific
Amgen Inc.
研究点 (19)
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