A Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety and Pharmacokinetics of Apitegromab in Overweight and Obese Adult Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 7
- 主要终点
- Change from Baseline in total Lean Body Mass (kg) at 24 weeks
研究概览
简要总结
A phase 2 study to evaluate the effects of apitegromab as an adjunctive therapy to GLP-1 receptor agonist therapy in subjects with overweight or obesity
详细描述
This phase 2 randomized, double-blind, placebo-controlled, multicenter study assessed the safety, efficacy, and pharmacokinetics (PK) of apitegromab when used as an adjunctive therapy to GLP-1 receptor agonist therapy in subjects with overweight and obesity and without diabetes. Each subject received tirzepatide throughout the treatment period. In addition, all subjects were randomized 1:1 to receive either apitegromab or placebo during the treatment period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Active treatment, randomized, double-blind, placebo-controlled
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to comprehend the informed consent process and provide written informed consent prior to study enrollment and the conduct of any study-related assessments to study enrollment and the conduct of any study-related assessments
- •Male or female, age ≥ 18 and ≤ 65 years at the time of informed consent
- •Stable body weight (±5 kg) within 90 days of Screening
- •At Screening, a BMI of:
- •≥30.0 kg/m2 to ≤45.0 kg/m2 or
- •≥27.0 kg/m2 to <30.0 kg/m2 with the presence of 1 or more weight-related comorbid condition(s). Note: See
排除标准
- •for specific organ class disease parameters
- •Exclusion Criteria:
- •History of or active cardiovascular, neurovascular, peripheral vascular, pulmonary, hepatic, pancreatic, neuromuscular, and/or psychiatric disease
- •Active malignancy, other than local subcutaneous squamous cell and basal cell carcinomas
- •History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to Screening
- •History of Type 1 diabetes or active Type 2 diabetes (T2D). If there was a history of T2D and it resolved, then the resolution must have occurred >12 months prior to Screening. Prediabetes managed with nonpharmacologic approaches (exercise and diet) is not an exclusion
研究组 & 干预措施
Cohort 1
Apitegromab + incretin mimetic
干预措施: Apitegromab (Drug)
Cohort 1
Apitegromab + incretin mimetic
干预措施: Tirzepatide (Drug)
Cohort 2
Placebo + incretin mimetic
干预措施: Placebo (Drug)
Cohort 2
Placebo + incretin mimetic
干预措施: Tirzepatide (Drug)
结局指标
主要结局
Change from Baseline in total Lean Body Mass (kg) at 24 weeks
时间窗: Baseline and 24 weeks
Dual-energy X-ray absorptiometry was used to evaluate body composition
次要结局
- Change from Baseline in body weight(Baseline and 24 weeks)
- Change from Baseline in percent lean body mass (%)(Baseline and 24 weeks)
- Change from Baseline in fat body mass (kg and %)(Baseline and 24 weeks)
- Change from Baseline in visceral adipose tissue (VAT), subcutaneous adipose tissue (SAT), and trunk fat body mass (kg and %)(Baseline and 24 weeks)
- Percent (%) of weight loss from baseline due to fat body mass loss(Baseline and 24 weeks)
- Percent (%) of weight loss from baseline due to lean body mass loss(Baseline and 24 weeks)
- Concentration of apitegromab in circulation over time(Baseline up to 40 weeks)
- Concentration of latent myostatin in circulation over time(Baseline up to 24 weeks)
- Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)(Baseline up to 40 weeks)
- Presence of anti-drug antibodies (ADA) against apitegromab over time(Baseline up to 40 weeks)