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

RecruitingPhase 2Ages 18 Years - 75 YearsAllEli Lilly and Company
NCT07545772 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 36 weeks.

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📋 Eligibility rules (as published)
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
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What it tests

  • LY3537031
  • Placebo
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Where

70 sites
Del Sol Research Management - Mesa
Mesa, United States
Smart Cures Clinical Research
Anaheim, United States
Om Research LLC
Lancaster, United States
United Medical Doctors - Los Alamitos
Los Alamitos, United States
Encore Medical Research
Hollywood, United States
Springfield Clinic - First
Springfield, United States
Gastroenterology Health Partners
New Albany, United States
Gastroenterology Health Partners
Louisville, United States

…and 62 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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