A Phase 2, Randomized, Double-blind, Placebo-controlled, Study of the Safety, Tolerability, and Efficacy of Increasing Optimal 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 (ACCESS II)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 85
- 试验地点
- 11
- 主要终点
- Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
研究概览
简要总结
Phase 2 clinical study will evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of various aleniglipron (GSBR-1290) dose regimens compared with placebo in participants living with obesity or overweight with ≥ 1 weight-related comorbidity, in addition to diet and exercise, over a 44-week 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
- 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
- •Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)
- •Use of medications intended to promote weight loss, within 6 months prior to Screening
研究组 & 干预措施
Cohort 1c
Participants will receive aleniglipron or placebo administered orally.
干预措施: aleniglipron or placebo (Drug)
Sentinel
Participants will receive aleniglipron or placebo administered orally.
干预措施: aleniglipron or placebo (Drug)
Cohort 1a
Participants will receive aleniglipron or placebo administered orally.
干预措施: aleniglipron or placebo (Drug)
Cohort 1b
Participants will receive aleniglipron or placebo administered orally.
干预措施: aleniglipron or placebo (Drug)
结局指标
主要结局
Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
时间窗: Baseline and week 44
Adverse events of special interest
时间窗: Baseline and week 44
Number of Participants With Clinically Significant Change From Baseline in Laboratory Parameters, including hematology, plasma chemistry, coagulation, and urinalysis
时间窗: Baseline and week 44
Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Parameters: Common ECG-related variables will be assessed, including but not limited to : heart rate and QRS duration
时间窗: Baseline and week 44
Number of Participants With Clinically Significant Change From Baseline in Vital Signs, including systolic and diastolic Blood Pressure, Heart Rate, Respiratory Rate, and temperature
时间窗: Baseline and week 44
次要结局
- Area Under the Plasma Concentration-time Curve From Time 0 to Tau (AUC0-tau)(Baseline and week 44)
- Maximum Observed Plasma Concentration (Cmax) of aleniglipron(Baseline and week 44)
- Trough Concentrations (Ctrough) of aleniglipron(Baseline and week 44)
- Time of Maximum Observed Plasma Concentration (Tmax) of aleniglipron(Baseline and week 44)
- Terminal Elimination Half-life (t1/2) for aleniglipron(Baseline and week 44)