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NCT Number: NCT07545772

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

The purpose of this study is to evaluate how well brenipatide (LY3537031) is tolerated what side effects may occur, and the safety and efficacy in participants with Irritable Bowel Syndrome-Constipation (IBS-C). The study drug will be administered subcutaneously (SC) (under the skin) when compared with placebo.

The study will last approximately 35 weeks.

Recruiting

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Key information

Conditions

Irritable Bowel Syndrome Colonic Diseases Colonic Diseases, Functional Constipation Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Sint Vincentius Ziekenhuis, Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3537031

Drug

Administered SC.

Other names: Brenipatide

Placebo

Drug

Administered SC.

Primary outcomes

  1. Percentage of Participants with a Weekly Composite Clinical Response for at Least 50 Percent (%) of Weeks

    Time frame: Week 9 to 16

Secondary outcomes

  1. Percentage of Participants with a Weekly Abdominal Pain Response for at Least 50% of Weeks

    Time frame: Week 9 to 16

  2. Percentage of Participants with a Weekly Complete Spontaneous Bowel Movement (CSBM) for at Least 50% of Weeks

    Time frame: Week 9 to 16

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

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

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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-C

Acronym: RENEW-IBS-C

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 22, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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