Mirikizumab Administered at the Same Time as Tirzepatide in Adult Participants With Moderately to Severely Active Ulcerative Colitis and Obesity or Overweight: Phase 3b Study
This study is investigating a new approach for adults living with moderately to severely active ulcerative colitis (UC) who are also overweight or obese. Researchers want to find out if using two medicines together, mirikizumab and tirzepatide, is more effective than using mirikizumab with a dummy treatment (placebo). The main goals are to see if this combination improves or gets rid of UC symptoms and helps people lose at least 10% of their body weight. The study will last for up to 61 weeks, including 52 weeks of treatment, to carefully observe the effects of these medicines.
At a glance
What is this study about?
This study is called a 'Phase 3b' study, which means it's a later stage of research building on earlier findings, and it's looking closely at a combination of two specific medicines for a particular group of people. It focuses on adults who have ulcerative colitis (UC) that is active to a moderate or severe degree, meaning their symptoms are significant and affect their daily life. Importantly, this study is specifically for people who are also overweight or living with obesity.
The main idea behind this research is to see if treating ulcerative colitis and also helping with weight management at the same time could lead to better overall health. One group of participants will receive mirikizumab along with tirzepatide, while another group will receive mirikizumab and a placebo (a dummy treatment that looks like tirzepatide but has no medicine in it). This comparison helps researchers understand if adding tirzepatide to mirikizumab makes a noticeable difference. The ultimate hope is to find a treatment approach that not only eases UC symptoms but also helps people achieve meaningful weight loss.
Researchers will carefully monitor participants to see how their UC symptoms change – whether they get better or even disappear. They will also track weight loss to see if participants lose at least one-tenth of their body weight. This study is important because it explores a new way to potentially help people with active UC who also face the challenges of being overweight or obese, aiming for improvements in both conditions. The study will run for just over a year, with most of that time spent on the treatment itself.
Key takeaways
- This study explores a new combined treatment for active ulcerative colitis and weight management.
- It aims to improve UC symptoms and achieve significant weight loss.
- The study involves two medicines: mirikizumab and tirzepatide (or a placebo).
- It's for adults aged 18-70 with moderately to severely active UC who are also overweight or obese.
- Participation lasts up to 61 weeks, with most of that time on treatment.
- Potential benefits include new treatment options; risks involve possible side effects.
Who may be eligible?
To join this study, adults aged 18 to 70 need to have a confirmed diagnosis of ulcerative colitis (UC) for at least three months, with clear signs of moderate to severe active UC shown by tests like a colonoscopy.
Participants also need to be overweight (with a Body Mass Index, or BMI, of 27 or higher, alongside other health conditions like high blood pressure or type 2 diabetes) or have obesity (a BMI of 30 or higher). On top of this, their UC must not have responded well to, or they couldn't tolerate, at least one common UC medicine, or even more advanced UC treatments like biologics. This means the study is for people whose UC has been difficult to control with standard care.
There are also reasons why someone might not be able to join. For example, if you have Crohn's disease, another type of inflammatory bowel disease that isn't UC, or if you've had certain bowel surgeries or need them in the future. These are just some of the main points, and the study team would check all your health details carefully.
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.
- Do you have a clear diagnosis of ulcerative colitis (UC)?
- Is your UC currently moderate to severe, with noticeable symptoms?
- Are you between 18 and 70 years old?
- Are you overweight (BMI of 27 or higher with other specific health issues) or living with obesity (BMI of 30 or higher)?
- Has your UC not responded well to, or have you had problems with, at least one previous UC medication?
- Have you NOT been diagnosed with Crohn's disease or other similar bowel conditions?
What does participation involve?
If you decide to take part in this study, you would be involved for up to 61 weeks, which is about 14 months. This includes 52 weeks (about a year) where you would be receiving the study medication. You would have regular visits to the clinic for check-ups, assessments, and to receive your study medicines. These assessments will involve tests to monitor your ulcerative colitis symptoms, your weight, and your general health, possibly including blood tests or other procedures. You'll be given either a combination of mirikizumab and tirzepatide, or mirikizumab and a placebo (a dummy medicine). Throughout the study, you'll be closely monitored by the study team, and you'll always have the right to withdraw from the study at any time.
Potential risks and benefits
Locations (190)
- 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 ulcerative colitis (UC)?
Ulcerative colitis is a long-term condition where the lining of your large intestine (colon and rectum) becomes inflamed and develops small sores, leading to symptoms like tummy pain, diarrhoea, and blood in your poo.
What does 'moderately to severely active' UC mean?
This means your ulcerative colitis symptoms are significant and impactful, not mild, and likely affecting your daily life. Doctors use specific scores to measure how active your UC is.
What is a placebo?
A placebo is a 'dummy' treatment that looks exactly like the real medicine but contains no active ingredients. It's used in studies to fairly compare the effects of a new medicine against no medicine.
Why include people who are overweight or have obesity?
This study specifically wants to see if combining treatments for UC and weight management can offer a better overall outcome for people who have both conditions. It's investigating how these two health areas might be linked in treatment.
How long will I be in the study?
If you join, your total participation time will be up to 61 weeks, which is about 1 year and 2 months. Most of this period, 52 weeks, will be spent actively receiving the study treatment.
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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