Health Trials

A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)

ConditionsIrritable Bowel SyndromeDiarrhea
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-Diarrhea (IBS-D). 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

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

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY3537031

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

531 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 Who Had a Daily Composite Response for at Least 50 Percent (%) of Days

Time frame
Week 9 to Week 16

Secondary outcomes

1

Percentage of Participants Who Had a Daily Abdominal Pain Response for at Least 50% of Days

Time frame
Week 9 to Week 16
2

Percentage of Participants Who Had Daily Stool Consistency Response for at Least 50% of Days

Time frame
Week 1 to Week 24
3

Percentage of Participants Who Had a Daily Composite Response

Time frame
Day 1 through Week 24

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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