This study focuses on treating people who have both Ulcerative Colitis (a condition causing inflammation in the large intestine) and are either overweight or have obesity. The study will test two medications: Mirikizumab, which is given as an injection, and Tirzepatide, also given as an injection under the skin. The purpose is to determine if using both medications together works better than using Mirikizumab with placebo for improving both the intestinal condition and reducing body weight.
The treatment will involve receiving regular injections of the study medications for up to 52 weeks. Mirikizumab is a type of medication called a monoclonal antibody, which works by targeting specific parts of the immune system. Tirzepatide is a medication that can help with weight management. Some participants will receive both active medications, while others will receive Mirikizumab with placebo.
The study will measure how many participants achieve two goals at the same time: improvement in their Ulcerative Colitis symptoms and a significant reduction in their body weight. The medications will be given through injections either under the skin or into a vein, depending on the specific medication being administered.
1Initial treatment phase
You will receive mirikizumab through subcutaneous injection (under the skin).
You will be randomly assigned to one of two groups: one receiving tirzepatide or one receiving a placebo (inactive substance).
The tirzepatide will be administered through subcutaneous injection using a pre-filled syringe.
2Treatment continuation
Regular injections of mirikizumab will continue throughout the study period.
If assigned to the tirzepatide group, the dose may be increased up to 15 mg, based on your response to treatment.
Your weight and ulcerative colitis symptoms will be monitored regularly.
3Medical assessments
Your progress will be evaluated through regular medical examinations.
Doctors will measure your body mass index (BMI) and assess your ulcerative colitis symptoms.
The study will track whether you achieve both improved gut health and weight reduction.
4Study duration
The study will continue until April 2028.
Regular follow-up visits will be required throughout the study period.
Your participation helps evaluate if combining these medications is effective for treating both ulcerative colitis and weight management.
Who Can Join the Study?
You must have been diagnosed with ulcerative colitis (UC) at least 3 months before the study starts, with confirmed test results
You must have moderate to severe ulcerative colitis activity, confirmed by specific medical tests within 21 days before starting the study
If you have had UC for 8 or more years, you need to have had a colonoscopy (examination of the large intestine using a camera) in the past year showing no signs of abnormal cell growth or cancer
You must be either:
Obese with a BMI of 30 or higher, or
Overweight with a BMI between 27 and 30 and have at least one of these conditions:
High blood pressure
Type 2 diabetes
Abnormal cholesterol levels
Sleep apnea
Heart disease
You must have previously tried at least one standard UC medication (such as oral corticosteroids or azathioprine) or advanced therapies (such as biologics or JAK inhibitors) without satisfactory results
You can be either male or female
You must be an adult (18 years or older)
Who Cannot Join the Study?
Age below 18 years old or above 65 years old
Previous severe allergic reactions to any medications
Current pregnancy or breastfeeding
Severe kidney problems (renal insufficiency)
Severe liver problems (hepatic dysfunction)
Active or recent serious infections
History of cancer in the past 5 years
Uncontrolled diabetes (high blood sugar levels)
Serious heart conditions
Current participation in other clinical trials
History of substance abuse in the past 2 years
Inability to follow study procedures
Major surgery within the past 3 months
Severe mental health conditions that could interfere with the study
Use of prohibited medications that could interact with study drugs
Body Mass Index (BMI) below required study threshold
Conditions that could interfere with weight measurement accuracy
History of bariatric surgery
Eating disorders such as anorexia or bulimia
Unstable medical conditions that could affect study results
Mirikizumab is a medication that targets inflammation in the body, specifically designed to treat ulcerative colitis. It works by blocking certain proteins that cause inflammation in the digestive system, helping to reduce symptoms and improve the condition of people with moderate to severe ulcerative colitis.
Tirzepatide is a medication used for weight management in people who are overweight or obese. It works by mimicking natural hormones in the body that help regulate blood sugar and appetite. This medication helps people feel fuller for longer periods and can lead to significant weight loss when combined with diet and exercise.
These medications are being studied together to see if they can help patients with ulcerative colitis who are also overweight or obese achieve both better control of their digestive condition and weight loss at the same time.
Obesity – A chronic condition characterized by excessive accumulation of body fat that increases body weight well above what is considered healthy. The condition develops gradually as a result of consuming more calories than the body uses, leading to fat storage. It affects multiple body systems and can impact daily activities. The body mass index (BMI) in obesity exceeds 30 kg/m².
Ulcerative Colitis – A chronic inflammatory bowel disease that causes inflammation and ulcers in the digestive tract, specifically affecting the innermost lining of the large intestine and rectum. The condition typically develops over time and can cause recurring episodes of inflammation. The disease causes the colon lining to become inflamed, forming small sores or ulcers that produce mucus and pus. Symptoms often develop gradually and can vary in severity.
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