A Phase 2b Double-Blind, Randomized, Placebo-Controlled Study of Bimagrumab and Tirzepatide, Alone or in Combination, to Investigate the Efficacy and Safety in Adult Participants With Obesity or Overweight With Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 180
- 试验地点
- 49
- 主要终点
- Percent Change from Baseline in Body Weight
研究概览
简要总结
The main purpose of this study is to see how well and how safely bimagrumab, tirzepatide, and the combination, work in lowering body weight in participants with obesity or overweight and type 2 diabetes. Participation in the study will last about 13 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have type 2 diabetes
- •Have a BMI of ≥27 kilograms per square meter (kg/m2)
- •Have had a stable body weight for the 3 months prior to randomization (<5% body weight gain and/or loss)
排除标准
- •Have a prior or planned surgical treatment for obesity,
- •Have type 1 diabetes, latent autoimmune diabetes, or history of ketoacidosis or hyperosmolar state or coma
- •Have poorly controlled hypertension
- •Have any of the following cardiovascular conditions within 3 months prior to screening:
- •acute myocardial infarction
- •cerebrovascular accident (stroke)
- •unstable angina, or
- •hospitalization due to congestive heart failure
- •Have a history of New York Heart Association (NYHA) Functional Classification III or IV congestive heart failure
- •Have ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes
- •Have ongoing or a history of bradyarrhythmias other than sinus bradycardia
- •Have renal impairment
- •Have a history of symptomatic gallbladder disease within the past 2 years
- •Have signs and symptoms of any liver disease
- •Have a disease or condition known to cause gastrointestinal malabsorption or a known clinically significant gastric emptying abnormality
- •Have a history of acute or chronic pancreatitis
- •Currently taking or have taken medications that may cause significant weight gain or promote weight loss within 3 months prior to screening
研究组 & 干预措施
Bimagrumab Dose 1 + Tirzepatide Placebo
Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC
干预措施: Bimagrumab (Drug)
Bimagrumab Dose 1 + Tirzepatide Placebo
Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC
干预措施: Tirzepatide Placebo (Drug)
Bimagrumab Dose 2 + Tirzepatide Placebo
Participants will receive bimagrumab SC and tirzepatide placebo SC
干预措施: Bimagrumab (Drug)
Bimagrumab Dose 2 + Tirzepatide Placebo
Participants will receive bimagrumab SC and tirzepatide placebo SC
干预措施: Tirzepatide Placebo (Drug)
Tirzepatide Dose 1 + Bimagrumab Placebo
Participants will receive tirzepatide SC and bimagrumab placebo SC
干预措施: Tirzepatide (Drug)
Tirzepatide Dose 1 + Bimagrumab Placebo
Participants will receive tirzepatide SC and bimagrumab placebo SC
干预措施: Bimagrumab Placebo (Drug)
Tirzepatide Dose 2 + Bimagrumab Placebo
Participants will receive tirzepatide SC and bimagrumab placebo SC
干预措施: Tirzepatide (Drug)
Tirzepatide Dose 2 + Bimagrumab Placebo
Participants will receive tirzepatide SC and bimagrumab placebo SC
干预措施: Bimagrumab Placebo (Drug)
Bimagrumab Dose 2 + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Bimagrumab (Drug)
Bimagrumab Dose 2 + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Tirzepatide (Drug)
Bimagrumab Dose 1 + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Bimagrumab (Drug)
Bimagrumab Dose 1 + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Tirzepatide (Drug)
Bimagrumab Dose 2 + Tirzepatide Dose 2
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Bimagrumab (Drug)
Bimagrumab Dose 2 + Tirzepatide Dose 2
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Tirzepatide (Drug)
Bimagrumab Dose 1 + Tirzepatide Dose 2
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Bimagrumab (Drug)
Bimagrumab Dose 1 + Tirzepatide Dose 2
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Tirzepatide (Drug)
Bimagrumab Placebo + Tirzepatide Placebo
Participants will receive bimagrumab placebo SC and tirzepatide placebo SC
干预措施: Bimagrumab Placebo (Drug)
Bimagrumab Placebo + Tirzepatide Placebo
Participants will receive bimagrumab placebo SC and tirzepatide placebo SC
干预措施: Tirzepatide Placebo (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 36
次要结局
- Change from Baseline in Hemoglobin A1c (HbA1c)(Baseline, Week 36)
- Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)(Baseline, Week 36)
- Percentage of Participants Achieving ≥5% Body Weight Reduction(Baseline, Week 36)
- Percentage of Participants Achieving ≥10% Body Weight Reduction(Baseline, Week 36)
- Percentage of Participants Achieving ≥15% Body Weight Reduction(Baseline, Week 36)
- Change from Baseline in Waist Circumference(Baseline, Week 36)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 36)
- Change from Baseline in Waist-to-Height Ratio (WHtR)(Baseline, Week 36)
- Percent Change from Baseline in Visceral Adipose Tissue (VAT) by Magnetic Resonance Imaging (MRI)(Baseline, Week 36)
- Change from Baseline in Liver Fat by MRI(Baseline, Week 36)
- Percent Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)(Baseline, Week 36)
- Percent Change from Baseline in Total Cholesterol(Baseline, Week 36)
- Percent Change from Baseline in Triglycerides (TG)(Baseline, Week 36)
- Change from Baseline in Systolic Blood Pressure (SBP)(Baseline, Week 36)
- Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC-ss) of Bimagrumab(Predose through Week 52)