2025-524973-17-00招募中2 期
J2S-MC-GZMS: 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
- 186
- 试验地点
- 31
- 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
To evaluate the efficacy of brenipatide relative to placebo in adult participants with IBS-D based on the daily composite clinical response from Weeks 9 to 16.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 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
- •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
Brenipatide, Brenipatide, Brenipatide
Test
干预措施: Brenipatide (Drug)
Placebo to match LY
Placebo
干预措施: Placebo to match LY (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.
Percentage of Participants Who Had a Daily Composite Response for at Least 50 Percent (%) of Days.
次要结局
未报告次要终点
研究者
Lilly Clinical Trials information desk
Scientific
Eli Lilly & Co.
研究点 (31)
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