What is brenipatide studying for Irritable Bowel Syndrome-Constipation (IBS-C)?

Brenipatide is being studied to understand how well it is tolerated, its side effects, and its safety and effectiveness in adults with IBS-C. Researchers want to see if it can improve symptoms like abdominal pain and bowel movements compared to a placebo. This research is sponsored by Eli Lilly and Company.

Who may be eligible for this Irritable Bowel Syndrome-Constipation clinical trial?

Adults aged 18 to 75 with IBS-C who meet specific symptom criteria may be eligible. Participants should have frequent hard or lumpy stools and significant abdominal pain. People with other types of IBS or certain gastrointestinal disorders are excluded. Please review eligibility criteria for more details.

Is there any cost to participate in this Irritable Bowel Syndrome-Constipation clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase 2

Age: 18Years - 75Years

All Genders

ID07545772

A Phase 2 Study to Evaluate Safety and Effectiveness of Brenipatide for Adults With Irritable Bowel Syndrome-Constipation IBS-C

Led by Eli Lilly and Company · Updated on 2026-08-06

342

Participants Needed

Research Sites

8 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating how well brenipatide LY3537031 is tolerated, its side effects, and its safety and effectiveness in adults with Irritable Bowel Syndrome-Constipation IBS-C. This Phase 2 study compares brenipatide given under the skin with a placebo to better understand its impact on IBS-C symptoms. The trial is sponsored by Eli Lilly and Company and lasts about 35 weeks. Participants will receive either brenipatide or a placebo, both administered subcutaneously. The study uses a randomized, double-blind, placebo-controlled design with parallel groups. Treatment effects will be measured primarily between weeks 9 and 16, focusing on the weekly composite clinical response. Secondary outcomes include abdominal pain and bowel movement responses during the same period. During the study, participants will be monitored for safety and symptom changes. They will record abdominal pain scores daily and bowel habits using a stool form scale. Researchers will review these data along with other health assessments to evaluate the study drugs effects. The total participation duration is approximately 35 weeks, including screening, treatment, and follow-up periods.

CONDITIONS

Brief Title

A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)

Who Can Participate

Age: 18Years - 75Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 75 years
Meet Rome IV criteria for IBS-C with more than 25% of bowel movements as hard or lumpy (Bristol Stool Form Scale Types 1 or 2)
Less than 25% of bowel movements as loose or watery (Bristol Stool Form Scale Types 6 or 7)
Average worst abdominal pain score of 3 or higher on a 0-to-10 scale during the 14 days before randomization

You will not qualify if you...

Diagnosis of IBS with diarrhea, mixed IBS, or unclassified IBS by Rome IV criteria
History of inflammatory or immune-mediated gastrointestinal disorders
Known clinically significant gastric emptying abnormality

Research Team

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Physicians interested in becoming principal investigators please contact

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