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

Phase 3

Recruiting

• Conditions: Ulcerative Colitis; Obesity or Overweight
• Interventions: Drug: Mirikizumab; Drug: Tirzepatide; Drug: Placebo

• Registration Number: NCT06937086
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to show whether in these individuals, treatment with both mirikizumab and tirzepatide, compared with treatment with mirikizumab and placebo, leads to decrease or disappearance of UC symptoms, and loss of at least one-tenth of the overall body weight.

Participation in this study will last up to 61 weeks, including 52 weeks of treatment.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-18
• Study First Submitted QC: 2025-04-18
• Study First Posted: 2025-04-22
• Study Start: 2025-06-26
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-15
• Last Update Posted: 2025-10-16
• Primary Completion: 2028-04
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 350

Inclusion 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 cancer.

• Have obesity, [body mass index (BMI) 30 kilograms per meter squared (kg/m2)]

• Have overweight (BMI ≥27 kg/m2 to <30 kg/m2) and in the presence of at least 1 of these weight-related comorbid conditions:

  • 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 example, mesalamine, sulfasalazine, olsalazine, and balsalazide) and/or who have an inadequate response to or a loss of response to, or are intolerant to advanced therapy for UC, defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies; anti-integrin antibodies, Janus kinase (JAK) inhibitors such as tofacitinib or upadacitinib, sphingosine 1-phosphate receptor 1inhibitors such as etrasimod or ozanimod, or anti-interleukin(IL)-12p40 antibodies, for example, ustekinumab.

Exclusion Criteria

• Have a current diagnosis of:

  • 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mirikizumab + Tirzepatide	Mirikizumab	Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.
Mirikizumab + Tirzepatide	Tirzepatide	Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.
Mirikizumab + Placebo	Mirikizumab	Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.
Mirikizumab + Placebo	Placebo	Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Simultaneously Achieve Clinical Remission and at Least 10% Weight Reduction	Week 52	Percentage of participants who simultaneously achieve clinical remission and at least 10% weight reduction.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Histologic Remission	Week 24 and Week 52	Percentage of participants achieving histologic remission.
Percentage of Participants Who Achieve Endoscopic Remission	Week 24 and Week 52	Percentage of participants who achieve endoscopic remission.
Percentage of Participants Who Achieve Clinical Remission	Week 24 and Week 52	Percentage of participants who achieve clinical remission.
Percentage of Participants Who Achieve Endoscopic Response	Week 24 and Week 52	Percentage of participants who achieve endoscopic response.
Percentage of Participants Who Achieve Mucosal Healing	Week 24 and Week 52	Percentage of participants who achieve mucosal healing.
Percentage of Participants Who Achieve Clinical Response	Week 24 and Week 52	Percentage of participants who achieve clinical response.
Percentage of Participants Who Achieve Bowel Movement Urgency Improvement Captured with Urgency Numeric Rating Scale (NRS)	Week 24 and Week 52	The Urgency NRS is a patient-reported, single-item instrument that measures the severity for the urgency, sudden, or immediate need, to have a bowel movement in the past 24 hours using an 11 point NRS ranging from 0 "no urgency" to 10 "worst possible urgency"

Trial Locations

Locations (191)

Digestive Health Specialists; 🇺🇸 Dothan, Alabama, United States

Smart Cures Clinical Research; 🇺🇸 Anaheim, California, United States

Cedars-Sinai Medical Center; 🇺🇸 Beverly Hills, California, United States

United Medical Doctors - Los Alamitos; 🇺🇸 Los Alamitos, California, United States

California Medical Research Associates; 🇺🇸 Northridge, California, United States

Research Associates of South Florida - Miami - Southwest 8th Street; 🇺🇸 Miami, Florida, United States

Gastro Health Research - Miami; 🇺🇸 Miami, Florida, United States

Orlando Health; 🇺🇸 Orlando, Florida, United States

Digestive and Liver Center of Florida; 🇺🇸 Orlando, Florida, United States

Gastro Health Research - Pensacola; 🇺🇸 Pensacola, Florida, United States

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