NCT07169942进行中（未招募）2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled, Study Evaluating the Effects of Aleniglipron (GSBR-1290) on Body Composition in Participants Living With Obesity (Body Mass Index ≥ 30 kg/m2)
Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics11 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2025年8月15日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 71
- 试验地点
- 11
- 主要终点
- Percent change in total body fat mass by DXA
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study evaluating the effects of aleniglipron on body composition in participants living with obesity. Participants will be randomized to aleniglipron or placebo in a ratio of 5:1. Participants will receive multiple ascending QD doses of aleniglipron or placebo in titration steps of 4 weeks duration for a total of 40 weeks of treatment.
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
- •Participants age ≥18 years and <80 years, with BMI ≥30 kg/m2
- •Screening HbA1c <6.5 %
排除标准
- •Previous documented diagnosis of diabetes mellitus
- •Self-reported change in body weight >5% within 3 months before Screening
- •Have a body weight, height, and/or width that prohibits the ability to obtain accurate measurements according to the DXA study specific manual that allows hemi-scan
- •Have a prior or planned surgical treatment for obesity (excluding liposuction or abdominoplasty, if performed >1 year prior to screening)
- •Have obesity induced by other endocrine disorders (such as Cushing's syndrome, Prader-Willi syndrome, or melanocortin 4 receptor deficiency)
研究组 & 干预措施
Cohort 1
Experimental
Participants will receive aleniglipron or placebo administered orally.
干预措施: aleniglipron or placebo (Drug)
Cohort 2
Experimental
Participants will receive aleniglipron or placebo administered orally.
干预措施: aleniglipron or placebo (Drug)
结局指标
主要结局
Percent change in total body fat mass by DXA
时间窗: Baseline and week 44
次要结局
- Percent change in body weight by DXA(Baseline and week 44)
- Percent change in waist circumference(Baseline and week 44)
- Percent change in visceral adipose tissue [VAT] by DXA(Baseline and week 44)
- Percent change in lean body mass by DXA(Baseline and week 44)
研究者
研究点 (11)
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