Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight
This research study is investigating two medications, mirikizumab and tirzepatide, for adults who have an active form of Crohn's disease and are also overweight or have obesity. The main goal is to find out if these treatments are effective at reducing Crohn's symptoms and if they are safe to use. Some participants will receive mirikizumab alone, some will receive mirikizumab with tirzepatide, and others will receive a placebo (a dummy treatment) to compare how well the real medications work. The study will last for up to 61 weeks and aims to offer new ways to help people with both Crohn's disease and weight concerns.
At a glance
What is this study about?
This study is for adults in the UK who have an active form of Crohn's disease – a long-term condition that causes inflammation in your digestive system. It's also specifically for people who are overweight or living with obesity. We know that managing both Crohn's disease and weight can be challenging, and this study aims to explore new treatment options.
The researchers want to test two different medications: mirikizumab and tirzepatide. Mirikizumab is a drug designed to reduce inflammation associated with Crohn's. Tirzepatide is a medication that helps with weight management and blood sugar control. The study will compare how well these drugs work, both on their own and together, against a 'placebo' (a treatment with no active drug) to truly understand their effects.
By taking part, you could be helping doctors learn more about how to effectively treat Crohn's disease in people who also have weight concerns. This knowledge could help many others in the future to manage their conditions better and improve their quality of life. The study will look closely at whether the treatments reduce Crohn's symptoms and how safe they are for participants.
Key takeaways
- This study is testing new treatments for Crohn's disease.
- It's for people with active Crohn's who are also overweight or have obesity.
- The study lasts up to 61 weeks (about 14 months).
- It aims to find out if the new drugs are safe and effective.
- You will receive regular medical check-ups as part of the study.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To be considered for this study, you need to be an adult between 18 and 70 years old with an official diagnosis of Crohn's disease that is currently moderate to severe. You must also be overweight or have obesity, meaning your Body Mass Index (BMI) is 27 or higher. If your BMI is between 27 and 30, you'd also need at least one other weight-related health problem, such as high blood pressure or type 2 diabetes.
Additionally, your Crohn's disease should have shown that it isn't responding well, has stopped responding, or you couldn't tolerate at least one standard or advanced treatment in the past. Your doctors will also need to confirm the extent and activity of your Crohn's through specific tests, including an endoscopy.
There are also some reasons why you might not be able to join. For example, if you have other bowel conditions like ulcerative colitis, a current infection like an abscess, or have had certain types of bowel surgery recently. People with type 1 diabetes or insulin-treated type 2 diabetes, or a history of severe low blood sugar, typically can't 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 70 years old?
- Have you been diagnosed with Crohn's disease that is currently active (moderate to severe)?
- Are you overweight (BMI of 27 or higher) or living with obesity?
- Has your Crohn's disease not responded well to previous treatments, or have you had side effects from them?
- Do you NOT have Ulcerative Colitis or Type 1 Diabetes?
- Have you NOT had certain major bowel surgeries in the last 3 months?
What does participation involve?
If you decide to join this study, your involvement would last for up to 61 weeks, which is about 14 months. Throughout this time, you would have regular visits to the clinic for medical check-ups, assessments, and to receive your study medication. The medication will be given as either mirikizumab, tirzepatide, a combination of both, or a placebo, and you won't know which one you're receiving.
These visits will involve various tests to monitor your Crohn's disease and your general health, such as blood tests, physical examinations, and potentially endoscopies to check the inflammation in your bowel. You would also be asked questions about your symptoms and how you're feeling. All these steps are to help the researchers understand how well the treatments work and if they are safe. You would be fully supported by the study team throughout your participation.
Potential risks and benefits
Locations (187)
- Digestive Health SpecialistsVerified postcodeDothan, United States· Recruiting
- Smart Cures Clinical ResearchVerified postcodeAnaheim, United States· Recruiting
- Cedars-Sinai Medical CenterVerified postcodeBeverly Hills, United States· Not yet recruiting
- United Medical Doctors - Los AlamitosVerified postcodeLos Alamitos, United States· Recruiting
- California Medical Research AssociatesVerified postcodeNorthridge, United States· Recruiting
- Research Associates of South Florida - Miami - Southwest 8th StreetVerified postcodeMiami, United States· Recruiting
- Gastro Health Research - MiamiVerified postcodeMiami, United States· Recruiting
- Orlando HealthVerified postcodeOrlando, United States· Recruiting
- Digestive and Liver Center of FloridaVerified postcodeOrlando, United States· Recruiting
- Gastro Health Research - PensacolaVerified postcodePensacola, United States· Recruiting
- Precision Clinical ResearchVerified postcodeSunrise, United States· Recruiting
- Grand Teton Research GroupVerified postcodeIdaho Falls, United States· Recruiting
Common questions
What is Crohn's disease?
Crohn's disease is a condition that causes inflammation in your digestive system, leading to symptoms like tummy pain, diarrhoea, and weight loss.
What does 'moderately to severely active' mean?
It means your Crohn's disease symptoms are currently bothering you quite a lot and show significant signs of inflammation.
What is a placebo?
A placebo is a 'dummy' treatment that looks like the real medicine but contains no active drug. It helps researchers compare the real treatment's effects.
Will I know which treatment I'm getting?
No, this is usually a 'blinded' study, meaning neither you nor your study doctor will know if you're receiving the active drug or the placebo.
How long will the study last for me?
If you join, your participation in the study would last for up to 61 weeks, which is just over a year.
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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