NCT07545759招募中2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Brenipatide in the Treatment of Adult Participants With IBS-D
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 531
- 试验地点
- 101
- 主要终点
- Percentage of Participants Who Had a Daily Composite Response for at Least 50 Percent (%) of Days
研究概览
简要总结
The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo.
The study will last approximately 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
- 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
- •Meet Rome IV criteria for IBS-D, which includes having greater than 25% of bowel movements with Bristol Stool Form Scale (BSFS) Types 6 or 7 and <25% of bowel movements with BSFS Types 1 or 2
- •Based on the daily eDiary collection during the screening period:
- •Have average of worst abdominal pain score of ≥3.0 on a 0-to-10-point scale during the 14 consecutive days prior to randomization
- •Have at least 4 days per week with a maximum BSFS ≥5 AND with at least 2 days of the 4 days per week with a maximum BSFS ≥6 during the 14 consecutive days prior to randomization
- •Have had no major changes in diet in the 4 weeks prior to screening
排除标准
- •Have a diagnosis of IBS with a subtype of constipation, mixed IBS, or unclassified IBS by the Rome IV criteria
- •Have a history of inflammatory or immune-mediated gastrointestinal disorders
- •Have a known clinically significant gastric emptying abnormality
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo administered SC
干预措施: Placebo (Drug)
LY3537031
Experimental
LY3537031 administered subcutaneously (SC)
干预措施: LY3537031 (Drug)
结局指标
主要结局
Percentage of Participants Who Had a Daily Composite Response for at Least 50 Percent (%) of Days
时间窗: Week 9 to Week 16
次要结局
- Percentage of Participants Who Had a Daily Abdominal Pain Response for at Least 50% of Days(Week 9 to Week 16)
- Percentage of Participants Who Had Daily Stool Consistency Response for at Least 50% of Days(Week 1 to Week 24)
- Percentage of Participants Who Had a Daily Composite Response(Day 1 through Week 24)
研究者
研究点 (101)
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