Brenipatide (LY3537031) treatment for adults with IBS‑D

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 study gives adults with IBS‑D subcutaneous injections of brenipatide (LY3537031) or placebo over an approximately 35‑week period to characterize safety, tolerability, side effects, and preliminary symptom effects. Participants complete a daily eDiary during screening and treatment to confirm Rome IV IBS‑D criteria and to track abdominal pain and stool form. The trial compares patient-reported outcomes between the brenipatide and placebo groups and excludes people with other IBS subtypes or inflammatory/immune‑mediated GI disorders. Dosing and follow-up visits occur at clinical sites in the United States.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

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
• Clinical Research of Osceola
  Kissimmee, Florida, United States Recruiting

+39 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Fecal microbiota transplantation for treating irritable bowel syndrome

  This study is testing if using stool from a healthy donor can help people with irritable bowel syndrome feel better by restoring a healthy balance of gut bacteria.

  Recruiting Phase 2 Mayo Clinic · Rochester, Minnesota · NCT05776914

• Gut health follow-along with Peachbiotic in adults

  This single-arm study tests whether Peachbiotic taken daily for 12 weeks helps adults with gut symptoms feel better.

  Recruiting Peach Perfect · Las Vegas, Nevada · NCT07927907

• Impact of a climate-resilient WASH package in Karamoja schools

  This study tests a climate-resilient water, sanitation and hygiene package in severely water-insecure primary schools in Karamoja to see if it reduces diarrhea and respiratory infections and improves attendance, especially among girls.

  Recruiting Unicef · Moroto · NCT07823231

• Do home water filters improve health for people with private wells in rural Central Appalachia

  This study tests whether providing point-of-use water filters to households using well or spring water in rural Central Appalachia can reduce acute gastrointestinal illness.

  Recruiting Virginia Polytechnic Institute and State University · Johnson City, Tennessee and 1 other locations · NCT07818902

• Liver Fat and Scarring in People Suspected of Non-Celiac Wheat Sensitivity

  This study looks to see if people with non-celiac wheat sensitivity have liver fat or fibrosis and how this relates to IBS/FD and celiac disease.

  Recruiting at 2 sites University of Palermo · Palermo, Palermo and 1 other locations · NCT07750535

• Balanced IV Fluids for Kids with Acute Gastroenteritis

  This study compares balanced crystalloids versus normal saline for IV hydration in young children with acute gastroenteritis to see if it improves acid–base status and clinical outcomes.

  Recruiting Aydin Adnan Menderes University · Aydin · NCT07610382

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.