A Phase 2b, Randomized, Double-blind, Placebo-controlled, Dose-range Finding Study of the Efficacy and Safety of Multiple Doses of Aleniglipron (GSBR-1290) in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2) or Overweight (Body Mass Index ≥ 27 kg/m2) With at Least One Weight-related Comorbidity
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 230
- 试验地点
- 39
- 主要终点
- Percent change in body weight from Baseline to Week 36
研究概览
简要总结
This study is a randomized, double-blind, placebo-controlled, dose-range finding study of the efficacy, safety, tolerability, PK, and PD of multiple doses of aleniglipron in participants living with overweight or obesity with at least one weight-related comorbidity. Participants will be randomized to aleniglipron or placebo in a ratio of 3:1 within each Cohort receiving multiple-ascending, QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 36 weeks of treatment. At the end of the study (after completing 36 weeks of treatment), participants will be offered to continue with an open-label extension (OLE) where they will receive aleniglipron for an additional 36 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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •BMI ≥30 kg/m2 or BMI ≥27.0 kg/m2 and previous/current diagnosis of ≥ 1 obesity related comorbidity
排除标准
- •Previous documented diagnosis of diabetes mellitus.
- •Self-reported change in body weight >5% within 3 months before Screening
- •Body weight ≤80 kg at Screening
- •Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)
研究组 & 干预措施
Cohort 1
Participants will receive Aleniglipron or Placebo administered orally.
干预措施: Aleniglipron or Placebo (Drug)
Cohort 2
Participants will receive Aleniglipron or Placebo administered orally.
干预措施: Aleniglipron or Placebo (Drug)
Cohort 3
Participants will receive Aleniglipron or Placebo administered orally.
干预措施: Aleniglipron or Placebo (Drug)
Cohort 1 OLE
Participants will receive Aleniglipron administered orally
干预措施: Aleniglipron (Drug)
Cohort 2 OLE
Participants will receive Aleniglipron administered orally
干预措施: Aleniglipron (Drug)
Cohort 3 OLE
Participants will receive Aleniglipron administered orally
干预措施: Aleniglipron (Drug)
Cohort 4 OLE
Participants will receive Aleniglipron administered orally
干预措施: Aleniglipron (Drug)
结局指标
主要结局
Percent change in body weight from Baseline to Week 36
时间窗: Baseline and week 36
Double Blind Period
AESI
时间窗: Baseline and week 72
Open -Label Extension
Evaluate the safety and tolerability of participants with abnormal vital signs, including blood pressure, heart rate, and temperature
时间窗: Baseline and week 72
Open -Label Extension
Percent change in body weight from Baseline to Week 36
时间窗: Baseline and week 36
Double Blind Period
TEAEs and SAEs
时间窗: Baseline and week 72
Open -Label Extension
Evaluate long-term safety and tolerability of aleniglipron as measured through electrocardiograms (including, but not limited to, the measurements of ventricular HR, PR interval, QRS duration, QT interval, and QTcF)
时间窗: Baseline and week 72
Open -Label Extension
Evaluate the safety and tolerability of participants with abnormal laboratory values, including hematology, serum chemistry, and coagulation
时间窗: Baseline and week 72
Open -Label Extension
次要结局
- Change in body weight (absolute) from Baseline to Week 36(Baseline and week 36)
- Change in waist circumference from Baseline to Week 36(Baseline and week 36)
- Change in body mass index from Baseline to Week 36(Baseline and week 36)
- Percentage of participants who achieve ≥15% reduction in body weight at Week 36(Baseline and week 36)
- Change in body mass index from Baseline to Week 36(Baseline and week 36)
- Change in waist circumference(Baseline to week 72 & Week 36-72)
- Percentage of participants who achieve ≥15% reduction in body weight at Week 36(Baseline and week 36)
- Percentage of participants who achieve ≥10% reduction in body weight(Baseline to week 72 & Week 36-72)
- Percentage of participants who achieve ≥5% reduction in body weight at Week 36(Baseline and week 36)
- Change in body weight (absolute) from Baseline to Week 36(Baseline and week 36)
- Change in waist circumference from Baseline to Week 36(Baseline and week 36)
- Percent change in body weight(Baseline to week 72 & Week 36-72)
- Percentage of participants who achieve ≥5% reduction in body weight(Baseline to week 72 & Week 36-72)
- Percentage of participants who achieve ≥10% reduction in body weight at Week 36(Baseline and week 36)
- Change in body weight(Baseline to week 72 & Week 36-72)
- Change in body mass(Baseline to week 72 & Week 36-72)
- Percentage of participants who achieve ≥15% reduction in body weight(Baseline to week 72 & Week 36-72)