Health Trials

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

ConditionsIrritable Bowel SyndromeConstipation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY3537031

    Drug

    Administered SC.

  • Placebo

    Drug

    Administered SC.

Treatment groups

342 Participants
are divided into 2 treatment groups
Group A: LY3537031Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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