A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
This study aims to discover if a new medicine, brenipatide (also known as LY3537031), is a good treatment for Irritable Bowel Syndrome with Diarrhea (IBS-D). People with IBS-D often experience tummy pain and frequent, loose bowel movements. We want to check how safe this medicine is, what side effects people might get, and how well it works to ease symptoms. Participants will receive the study medicine or a dummy treatment (placebo) as an injection under the skin. The study will last for about 35 weeks and involves a comparison to see if brenipatide is more helpful than no active treatment.
At a glance
What is this study about?
This research study is focused on a new medicine called brenipatide, also known as LY3537031. It's being tested for people who suffer from Irritable Bowel Syndrome – Diarrhea type, or IBS-D. If you have IBS-D, you probably know that it means you often have tummy pain and bowel movements that are frequently loose or watery.
The main goal of this study is to understand how well brenipatide works. We want to see if it can help reduce the bothersome symptoms of IBS-D, like tummy pain and diarrhea. We also need to check how safe it is and if there are any side effects that people experience when taking it. This is a common and important step when developing new medicines, to make sure they are both effective and safe for people to use.
Participants in the study will be given either the new medicine or a 'placebo'. A placebo looks exactly like the real medicine but doesn't contain any active drug. This helps us compare whether any improvements seen are due to the medicine itself or other factors. The medicine will be given as a small injection under the skin. The study is designed to help us learn more about potential new ways to manage IBS-D symptoms.
Key takeaways
- This study is testing a new medicine, brenipatide, for IBS with Diarrhea (IBS-D).
- It aims to check if the medicine is safe, what side effects it has, and if it helps symptoms.
- Participants will receive either the new medicine or a dummy treatment (placebo) as an injection.
- The study involves regular clinic visits and keeping a daily symptom diary.
- It will last about 35 weeks, and you can stop at any time.
Who may be eligible?
To be considered for this study, you need to be an adult between 18 and 75 years old and have been diagnosed with IBS-D. This means your doctors have confirmed you have IBS and your bowel movements are mostly loose or watery (like Bristol Stool Form Scale types 6 or 7) for at least 25% of the time, and you don't usually have very hard stools.
During a screening period before the study starts, we'll ask you to keep a daily diary of your symptoms. To be eligible, you'd need to be experiencing tummy pain that's at least a 3 out of 10 on most days for two weeks, and have frequent loose or watery bowel movements for at least 4 days a week during that same period. We would also check that your diet hasn't changed a lot in the month leading up to the study.
There are also some reasons why you might not be able to join. For example, if you have a different type of IBS (like IBS with constipation), or if you have other gut conditions such as inflammatory bowel disease, or if you have major issues with how your stomach empties food. This helps us make sure the study includes people who truly fit the IBS-D profile being investigated.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Am I between 18 and 75 years old?
- Have I been diagnosed with IBS-D, where diarrhea is my main symptom?
- Do I currently have frequent tummy pain (at least 3 out of 10) for two weeks?
- Do I have loose or watery bowel movements at least 4 days a week?
- Do I NOT have other gut conditions like inflammatory bowel disease (IBD)?
What does participation involve?
If you join this study, you'll be involved for about 35 weeks. During this time, you will receive either the study medicine (brenipatide) or a placebo, which looks identical but has no active drug. This will be given as a small injection just under your skin.
You'll have regular visits to the clinic where you'll be carefully checked by the study team. These visits will involve various tests and assessments to monitor your health, how you're feeling, and any changes in your IBS symptoms. You will also be asked to keep a daily diary of your symptoms to help us track how the treatment is affecting you over time.
The research team will explain exactly what's involved in each visit, how to take the medicine, and what information you'll need to record at home. They'll also be available to answer any questions you have throughout your participation.
Potential risks and benefits
Locations (88)
- Del Sol Research Management - MesaVerified postcodeMesa, United States· Not yet recruiting
- Smart Cures Clinical ResearchVerified postcodeAnaheim, United States· Not yet recruiting
- Om Research LLCVerified postcodeLancaster, United States· Not yet recruiting
- United Medical Doctors - Los AlamitosVerified postcodeLos Alamitos, United States· Not yet recruiting
- Encore Medical ResearchVerified postcodeHollywood, United States· Not yet recruiting
- Clinical Research of OsceolaVerified postcodeKissimmee, United States· Not yet recruiting
- Springfield Clinic - FirstVerified postcodeSpringfield, United States· Recruiting
- Gastroenterology Health PartnersVerified postcodeNew Albany, United States· Not yet recruiting
- Gastroenterology Health PartnersVerified postcodeLouisville, United States· Not yet recruiting
- Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research CenterVerified postcodeWyoming, United States· Not yet recruiting
- Ohio GastroenterologyVerified postcodeColumbus, United States· Not yet recruiting
- University GastroenterologyVerified postcodeProvidence, United States· Not yet recruiting
Common questions
What is IBS-D?
IBS-D stands for Irritable Bowel Syndrome with Diarrhea, a common gut condition where people experience tummy pain and frequent, loose bowel movements.
What is brenipatide (LY3537031)?
Brenipatide is a new medicine being tested in this study to see if it can help people with IBS-D. It's given as an injection under the skin.
What is a 'placebo'?
A placebo is a dummy treatment that looks just like the real medicine but doesn't contain any active drug. It helps researchers compare the effects of the new medicine.
How long will I be in the study?
If you join, your involvement in the study will last for approximately 35 weeks (about 8 months).
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, for any reason, and it won't affect your medical care.
How to find out more
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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