A Phase 2, 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 Without Type 2 Diabetes
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 252
- 试验地点
- 24
- 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 evaluate the efficacy and safety of Bimagrumab and Tirzepatide, alone or in combination, in adults with obesity or overweight, with at least one obesity related comorbidity, without Type 2 Diabetes. The study will last about 70 weeks.
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 a BMI of
- •≥30 kilograms per square meter (kg/m2) or
- •≥27 kg/m2 and <30 kg/m2, with at least one of the following weight-related comorbidities:
- •Hypertension
- •Dyslipidemia
- •Cardiovascular disease
- •Obstructive sleep apnea
- •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 at least one laboratory value suggestive of diabetes during screening
- •Use of metformin, or any other glucose-lowering medications
- •Have Type 1 Diabetes, latent autoimmune diabetes, been diagnosed with any form of diabetes mellitus except for a prior diagnosis of gestational diabetes mellitus, or history of ketoacidosis or hyperosmolar 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 ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes
- •Have ongoing or a history of bradyarrhythmias other than sinus bradycardia
- •Have a history of New York Heart Association (NYHA) Functional Classification III or IV congestive heart failure
- •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
- •Have renal impairment, measured as estimated glomerular filtration rate <30 mL/minute/1.73 m2
- •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
Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Bimagrumab (Drug)
Part A: Bimagrumab Placebo + Tirzepatide Dose 1
Participants will receive bimagrumab placebo SC and tirzepatide SC
干预措施: Bimagrumab Placebo (Drug)
Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Bimagrumab (Drug)
Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Tirzepatide (Drug)
Part A: Bimagrumab Placebo + Tirzepatide Placebo
Participants will receive bimagrumab placebo SC and tirzepatide placebo SC
干预措施: Bimagrumab Placebo (Drug)
Part B: Bimagrumab Placebo + Tirzepatide Placebo
Participants will receive bimagrumab placebo SC and tirzepatide placebo SC
干预措施: Bimagrumab Placebo (Drug)
Part A: Bimagrumab Dose 2 + Tirzepatide Dose 2
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Tirzepatide (Drug)
Part A: Bimagrumab Placebo + Tirzepatide Placebo
Participants will receive bimagrumab placebo SC and tirzepatide placebo SC
干预措施: Tirzepatide Placebo (Drug)
Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Bimagrumab (Drug)
Part B: Bimagrumab Dose 2 (fast titration) + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Tirzepatide (Drug)
Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Tirzepatide (Drug)
Part B: Bimagrumab Dose 2 (slow titration) + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Bimagrumab (Drug)
Part A: Bimagrumab Placebo + Tirzepatide Dose 2
Participants will receive bimagrumab placebo SC and tirzepatide SC
干预措施: Bimagrumab Placebo (Drug)
Part A: Bimagrumab Dose 2 + Tirzepatide Placebo
Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC
干预措施: Bimagrumab (Drug)
Part A: Bimagrumab Dose 2 + Tirzepatide Placebo
Participants will receive bimagrumab subcutaneously (SC) and tirzepatide placebo SC
干预措施: Tirzepatide Placebo (Drug)
Part A: Bimagrumab Dose 1 + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Bimagrumab (Drug)
Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Bimagrumab (Drug)
Part A: Bimagrumab Dose 1 + Tirzepatide Dose 2
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Tirzepatide (Drug)
Part B: Bimagrumab Placebo + Tirzepatide Placebo
Participants will receive bimagrumab placebo SC and tirzepatide placebo SC
干预措施: Tirzepatide Placebo (Drug)
Part B: Bimagrumab Dose 2 (no titration) + Tirzepatide Dose 1
Participants will receive bimagrumab SC and tirzepatide SC
干预措施: Tirzepatide (Drug)
Part B: Bimagrumab Dose 1 + Tirzepatide Placebo
Participants will receive bimagrumab SC and tirzepatide placebo SC
干预措施: Bimagrumab (Drug)
Part B: Bimagrumab Dose 1 + Tirzepatide Placebo
Participants will receive bimagrumab SC and tirzepatide placebo SC
干预措施: Tirzepatide Placebo (Drug)
Part A: Bimagrumab Placebo + Tirzepatide Dose 1
Participants will receive bimagrumab placebo SC and tirzepatide SC
干预措施: Tirzepatide (Drug)
Part A: Bimagrumab Placebo + Tirzepatide Dose 2
Participants will receive bimagrumab placebo SC and tirzepatide SC
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Percent Change from Baseline in Body Weight
时间窗: Baseline, Week 24
次要结局
- Percent Change from Baseline in Total Body Fat Mass by Dual-Energy X-Ray Absorptiometry (DXA)(Baseline, Week 24, Week 48)
- Change from Baseline in Body Weight(Baseline, Week 24, Week 48)
- Percentage of Participants Achieving ≥5% Body Weight Reduction(Baseline, Week 24, Week 48)
- Percentage of Participants Achieving ≥10% Body Weight Reduction(Baseline, Week 24, Week 48)
- Percentage of Participants Achieving ≥15% Body Weight Reduction(Baseline, Week 24, Week 48)
- Change from Baseline in Waist Circumference(Baseline, Week 24, Week 48)
- Change from Baseline in Body Mass Index (BMI)(Baseline, Week 24, Week 48)
- Change from Baseline in Waist-to-Height Ratio (WHtR)(Baseline, Week 24, Week 48)
- Percent Change from Baseline in Visceral Adipose Tissue (VAT)(Baseline, Week 24, Week 48)
- Percent Change from Baseline in Total Body Lean Mass by DXA(Baseline, Week 24, Week 48)