Ulcerative Colitis study: Mirikizumab vs Tirzepatide
Official title 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
ClinicalTrials.gov ID: NCT06937086
What this study is testing
What is Mirikizumab?
an investigational IV monoclonal antibody being studied as a potential treatment for ulcerative colitis is designed to block interleukin‑23 signaling in the immune system
Also referred to as LY3074828.
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 study wants to find out if adding tirzepatide to mirikizumab reduces ulcerative colitis symptoms and leads to at least 10% body‑weight loss compared with mirikizumab alone.
- Who it's for
- Adults with moderately to severely active ulcerative colitis who are overweight or obese.
- What's involved
- Participants will receive either mirikizumab plus tirzepatide or mirikizumab plus a placebo, with regular clinic visits and tests to monitor symptoms and weight.
- Time commitment
- The trial lasts up to 61 weeks, including 52 weeks of treatment and scheduled study visits.
- Phase 3: a large, late-stage study
- 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 70
You may be able to join if
- Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that...
- Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by...
- Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to...
- Have obesity, [body mass index (BMI) 30 kilograms per meter squared (kg/m2)]
- hypertension
You likely can't join if
- Crohn's disease
- inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or
- primary sclerosing cholangitis.
- Have had or will need bowel resection or intestinal or intra-abdominal surgery.
- Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope.
- Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.
See the full eligibility criteria
- Have had an established diagnosis of UC for ≥3 months before baseline which includes endoscopic evidence of UC and a histopathology report that supports a diagnosis of UC.
- Have moderately to severely active UC as defined by a modified Mayo score (mMS) of 5 to 9 points and endoscopic subscore (ES) of 2 to 3 (confirmed by central review) within 21 days before baseline.
- Participants with a history of UC for greater than or equal to 8 years who have had a surveillance colonoscopy completed within 1 year prior to baseline must have documented negative results for colorectal dysplasia and...
- Have obesity, [body mass index (BMI) 30 kilograms per meter squared (kg/m2)]
- hypertension
- Type 2 Diabetes Mellitus (T2DM)
- dyslipidemia
- obstructive sleep apnea, or
- cardiovascular disease.
- Have an inadequate response to, loss of response to, or intolerance to at least 1 of the conventional medication: oral corticosteroids, oral azathioprine (AZA) or 6-mercaptopurine (6-MP), or oral 5-aminosalicylates (for...
- Crohn's disease
- inflammatory bowel disease (IBD) unclassified (formerly known as indeterminate colitis), or
- primary sclerosing cholangitis.
- Have had or will need bowel resection or intestinal or intra-abdominal surgery.
- Have evidence of toxic megacolon, or stricture or stenosis within the colon that cannot be traversed by a sigmoidoscope or colonoscope.
- Have a diagnosis of Type 1 Diabetes Mellitus (T1DM) or have insulin-treated T2DM.
- Have a history of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening.
- Have a self-reported change in body weight greater than 5% (gain or reduction) within 3 months prior to screening.
- Have a current or recent acute, active infection.
The study team makes the final eligibility decision.
Where it is enrolling
- Dothan, Alabama, United States
- Anaheim, California, United States
- Beverly Hills, California, United States
- Los Alamitos, California, United States
- Northridge, California, United States
- Miami, Florida, United States
- Orlando, Florida, United States
- Pensacola, Florida, United States
- Sunrise, Florida, United States
- Idaho Falls, Idaho, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- New Albany, Indiana, United States
- Louisville, Kentucky, United States
- New Iberia, Louisiana, United States
- Shreveport, Louisiana, United States
- Chevy Chase, Maryland, United States
- New Bedford, Massachusetts, United States
- St Louis, Missouri, United States
- Lebanon, New Hampshire, United States
+ 139 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, but 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 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Dothan, Alabama, United States; Anaheim, California, United States; Beverly Hills, California, United States; Los Alamitos, California, United States; Northridge, California, United States; Miami, Florida, United States and 153 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.