A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
This research study is looking at a new medicine called brenipatide (LY3537031) for people who have Irritable Bowel Syndrome with Constipation, often called IBS-C. The main goals are to check if the new medicine is safe, to understand any side effects it might cause, and to see how well it works to improve symptoms compared to a dummy medicine (placebo). The medicine will be given as an injection just under the skin. We're hoping to find a new way to help people manage their IBS-C symptoms better. The study is expected to last about 35 weeks.
At a glance
What is this study about?
This study is designed to explore a new potential treatment for Irritable Bowel Syndrome with Constipation (IBS-C). IBS-C is a common condition that can cause tummy pain, bloating, and difficulty with bowel movements. We're investigating a medicine called brenipatide (LY3537031) to see how effective and safe it is for people experiencing these symptoms.
In this study, some participants will receive the new medicine, while others will receive a 'placebo'. A placebo looks exactly like the medicine but contains no active drug. This allows us to fairly compare the effects of the new medicine against what happens when people believe they are getting treatment, helping us understand the medicine's true benefit.
The medicine will be given as an injection just under the skin. We will carefully monitor participants to see if the medicine helps improve their IBS-C symptoms, such as abdominal pain and constipation. We will also be paying close attention to any side effects that might occur, as understanding both the benefits and risks is crucial for developing new treatments.
Key takeaways
- This study is testing a new medicine for Irritable Bowel Syndrome with Constipation (IBS-C).
- It aims to check the medicine's safety, side effects, and how well it works.
- The medicine is given as an injection under the skin.
- The study includes a placebo group for comparison.
- It lasts approximately 35 weeks and involves regular check-ups.
- You can stop participating at any time if you wish.
Who may be eligible?
To join this study, you need to be an adult between 18 and 75 years old and have been diagnosed with Irritable Bowel Syndrome with Constipation (IBS-C) according to specific medical guidelines (called Rome IV criteria). This means your condition should include regular constipation (how doctors describe stools based on their shape) and also experience tummy pain that is at least a moderate level on most days.
There are also some reasons why you might not be able to take part. For example, if your IBS mainly involves diarrhoea, or if it's a mix of both constipation and diarrhoea, this study might not be suitable. Also, if you have other gut conditions like inflammatory bowel disease (Crohn's or Ulcerative Colitis) or problems with how food moves through your stomach, you wouldn't be able to join.
The study team will carefully check your medical history and current health to make sure you meet all the criteria and that it's safe for you to participate.
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.
- Are you between 18 and 75 years old?
- Have you been diagnosed with Irritable Bowel Syndrome-Constipation (IBS-C)?
- Do you experience tummy pain that is at least moderate on most days?
- Do you NOT have IBS with diarrhoea or mixed IBS?
- Do you NOT have other serious gut conditions like inflammatory bowel disease?
What does participation involve?
If you decide to take part, the study will last about 35 weeks, which is roughly eight months. Throughout this time, you will have regular visits to the clinic where the study team will monitor your health and how you’re feeling. You'll receive the study medicine (either brenipatide or a placebo) as an injection just under your skin.
You'll be asked to keep a daily electronic diary (eDiary) to record your symptoms, such as tummy pain and bowel movements. This helps the team understand how the medicine is affecting you day-to-day. There will also be appointments where the team will take measurements, ask about your general health, and check for any side effects.
Potential risks and benefits
Locations (70)
- Del Sol Research Management - MesaVerified postcodeMesa, United States· Recruiting
- Smart Cures Clinical ResearchVerified postcodeAnaheim, United States· Recruiting
- Om Research LLCVerified postcodeLancaster, United States· Recruiting
- United Medical Doctors - Los AlamitosVerified postcodeLos Alamitos, United States· Recruiting
- Encore Medical ResearchVerified postcodeHollywood, United States· Recruiting
- Springfield Clinic - FirstVerified postcodeSpringfield, United States· Recruiting
- Gastroenterology Health PartnersVerified postcodeNew Albany, United States· Recruiting
- Gastroenterology Health PartnersVerified postcodeLouisville, United States· Recruiting
- New York Gastroenterology AssociatesVerified postcodeNew York, United States· Recruiting
- Ohio GastroenterologyVerified postcodeColumbus, United States· Recruiting
- University GastroenterologyVerified postcodeProvidence, United States· Recruiting
- Biopharma Informatic, LLCVerified postcodeMcAllen, United States· Recruiting
Common questions
What is IBS-C?
IBS-C stands for Irritable Bowel Syndrome with Constipation. It's a common gut condition that causes tummy pain, bloating, and difficulty having regular bowel movements.
What is a placebo?
A placebo is a 'dummy' medicine that looks like the real thing but contains no active drug. It helps researchers understand the true effects of the new medicine.
How is the medicine given?
The medicine (or placebo) will be given as an injection just under your skin.
How long will the study last?
The study is expected to last for about 35 weeks, which is roughly eight months.
Can I leave the study if I change my mind?
Yes, you can leave the study at any time, for any reason, without it affecting your regular 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?
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