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New treatment option for Irritable Bowel Syndrome
Official title A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
ClinicalTrials.gov ID: NCT07545759
What this study is testing
What is LY3537031?
LY3537031 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for irritable bowel syndrome.
Also referred to as Brenipatide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- 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
- 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...
- Have had no major changes in diet in the 4 weeks prior to screening
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Mesa, Arizona, United States
- Anaheim, California, United States
- Lancaster, California, United States
- Los Alamitos, California, United States
- Hollywood, Florida, United States
- Kissimmee, Florida, United States
- Springfield, Illinois, United States
- New Albany, Indiana, United States
- Louisville, Kentucky, United States
- Wyoming, Michigan, United States
- Rochester, Minnesota, United States
- Columbus, Ohio, United States
- Providence, Rhode Island, United States
- McAllen, Texas, United States
- San Antonio, Texas, United States
- Antwerp, Belgium
- Bruges, Belgium
- Brussels, Belgium
- Edegem, Belgium
- Ghent, Belgium
+ 62 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Mesa, Arizona, United States; Anaheim, California, United States; Lancaster, California, United States; Los Alamitos, California, United States; Hollywood, Florida, United States; Kissimmee, Florida, United States and 76 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.