Phase 2: testing LY3537031 for Irritable Bowel Syndrome

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are LY3537031, or Placebo. The registry lists allocation as randomized. This study wants to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and the safety and how well it works in participants with Irritable Bowel Syndrome-Diarrhea (IBS-D).

They plan to enroll about 531 people at 89 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: LY3537031, Placebo

Primary outcome (registry wording): Percentage of Participants Who Had a Daily Composite Response for at Least 50 Percent (%) of Days

Who it is for (from inclusion criteria)

• Ages 18 Years to 75 Years
• 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