This study focuses on people who have both Crohn’s Disease (a long-term condition causing inflammation in the digestive system) and are either overweight or have obesity. The study will test two medications: mirikizumab (an injectable medication that helps reduce inflammation) and tirzepatide (an injectable medication that may help with weight management). The purpose is to see if using both medications together works better than using mirikizumab alone for improving both Crohn’s Disease symptoms and helping with weight loss.
The study will use different combinations of these medications. Some participants will receive both mirikizumab and tirzepatide, while others will receive mirikizumab and a placebo. Both medications are given as injections under the skin, except in some cases where mirikizumab may be given through a vein. The treatment will continue for 52 weeks, which is approximately one year.
The study will measure how well the medications work together to achieve three main goals: reducing Crohn’s Disease symptoms, healing the inside of the digestive tract, and helping participants lose weight. The amount of tirzepatide used in the study may be adjusted up to 15 milligrams, depending on how well it is tolerated.
1Initial health assessment
Your doctor will confirm that you have had Crohn’s disease for at least 3 months
Your disease activity will be measured using a special score (CDAI) that must be at least 220
A medical examination will confirm that you have either:
– obesity (BMI of 30 or higher) or
– are overweight (BMI between 27-30) with additional health conditions such as high blood pressure, type 2 diabetes, abnormal cholesterol levels, sleep apnea, or heart disease
2Medical history verification
Your medical records will be reviewed to confirm that you have previously tried:
– at least one standard Crohn’s disease medication (such as corticosteroids or azathioprine)
– advanced therapies that did not work well enough for your condition
If your Crohn’s disease has affected mainly your colon for 8 or more years, results from a colonoscopy done within the past year must show no signs of cancer or pre-cancerous changes
3Treatment period
The study will last until May 2028
You will receive either:
– Mirikizumab and Tirzepatide together, or
– Mirikizumab and a placebo
Both medications will be given as injections under the skin (subcutaneous injection)
Your progress will be monitored for 52 weeks to check if you achieve:
– improvement in Crohn’s disease symptoms
– healing of the intestinal lining
– at least 10% reduction in weight
Who Can Join the Study?
You must have been diagnosed with Crohn’s disease for at least 3 months before joining the study, with medical tests confirming the diagnosis
You must have moderate to severe Crohn’s disease with a CDAI score (a measure of disease activity) of at least 220
You must have a SES-CD score (a measure of disease severity seen during endoscopy) of at least 6, or 4 if the disease only affects the small intestine
If you have Crohn’s disease mainly affecting your colon for 8 or more years, you need to have had a colonoscopy in the past year showing no signs of precancerous changes or cancer
You must either:
Be obese with a BMI of 30 or higher, or
Be overweight with a BMI between 27-30 and have at least one of these conditions: high blood pressure, type 2 diabetes, high cholesterol, sleep apnea, or heart disease
You must have previously tried and not responded well to:
At least one standard Crohn’s disease medication (such as corticosteroids or azathioprine), and
Advanced treatments (such as biologics or JAK inhibitors)
You must be an adult (18 years or older)
Both men and women can participate
Who Cannot Join the Study?
Age below 18 or above 65 years
Pregnancy or breastfeeding women
Current or recent (within 3 months) treatment with medications that affect body weight
History of bariatric surgery (weight loss surgery)
Severe active inflammatory bowel disease (serious inflammation of digestive tract)
Unstable heart conditions or recent heart problems
Uncontrolled high blood pressure
Active infections or serious infections in the past 3 months
History of cancer in the past 5 years (except successfully treated skin cancer)
Severe liver disease
Severe kidney disease
Type 1 diabetes
History of pancreatitis (inflammation of pancreas)
Active substance abuse or addiction
Mental health conditions that could interfere with study participation
Participation in another clinical trial within the past 30 days
Known allergies to study medications or their components
Mirikizumab is a medication that targets inflammation in the body. It works by blocking a specific protein that causes inflammation in Crohn’s disease. This medication is designed to help reduce symptoms and improve the condition of people with moderate to severe Crohn’s disease.
Tirzepatide is a medication that helps with weight management and blood sugar control. It works by mimicking natural hormones in the body that regulate appetite and metabolism. In this trial, it is being studied alongside mirikizumab to see if the combination can help patients achieve both better control of their Crohn’s disease and weight reduction.
Crohn’s Disease – A long-term inflammatory bowel disease that can affect any part of the digestive tract, from mouth to anus. The condition causes inflammation of the digestive tract lining, which can lead to abdominal pain, severe diarrhea, fatigue, and weight loss. The inflammation often spreads deep into affected tissues and can occur in different areas of the digestive tract in different people. The disease usually develops gradually, but sometimes can worsen quickly.
Obesity – A complex 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 over an extended period. It affects the whole body and can impact various body systems and organs. The amount of body fat is usually measured using body mass index (BMI), with obesity defined as a BMI of 30 or greater.
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