Brenipatide (LY3537031) for IBS with constipation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial compares subcutaneous brenipatide (LY3537031) to placebo in participants who meet Rome IV criteria for IBS-C. Participants will be treated and followed for approximately 35 weeks with regular clinic visits and daily symptom reporting via an eDiary, including worst abdominal pain scores and Bristol Stool Form Scale entries. The protocol emphasizes safety and tolerability monitoring alongside measures of efficacy for constipation and pain. Exclusion criteria remove those with diarrhea-predominant or mixed IBS, inflammatory gastrointestinal disorders, or clinically significant gastric emptying abnormalities.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Meets Rome IV criteria for irritable bowel syndrome-constipation (IBS-C) including having more than 25% bowel movements with Bristol Stool Form Scale (BSFS) Types 1 or 2 and less than 25% of bowel movements with BSFS Types 6 or 7
* 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

Exclusion Criteria:

* Have a diagnosis of irritable bowel syndrome (IBS) with a subtype of diarrhea, 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

Where it's running

• Del Sol Research Management - Mesa
  Mesa, Arizona, United States Recruiting
• Smart Cures Clinical Research
  Anaheim, California, United States Recruiting
• Om Research LLC
  Lancaster, California, United States Recruiting
• United Medical Doctors - Los Alamitos
  Los Alamitos, California, United States Recruiting
• Encore Medical Research
  Hollywood, Florida, United States Recruiting
• Springfield Clinic - First
  Springfield, Illinois, United States Recruiting

+20 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.