Mirikizumab and Tirzepatide Administered in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

Phase 3

Recruiting

• Conditions: Crohn's Disease; Obesity or Overweight
• Interventions: Drug: Mirikizumab; Drug: Tirzepatide; Drug: Placebo

• Registration Number: NCT06937099
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to evaluate the efficacy and safety of mirikizumab and placebo compared with mirikizumab and concomitantly administered tirzepatide in adult participants with moderately to severely active CD and obesity, or overweight.

The maximum duration of this study is up to 61 weeks.

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: 2025-09
• Last Update Submitted: 2025-09-08
• Last Update Posted: 2025-09-09
• Primary Completion: 2028-05
• Study Completion: 2028-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 290

Inclusion Criteria

• Have had a diagnosis of Crohn's disease (CD) or perianal fistulizing CD established at least 3 months prior to enrollment confirmed by clinical, endoscopic, and histological criteria.

• Have obesity body mass index 30 kilograms per meter squared (BMI ≥30 kg/m2), or 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 moderately to severely active CD defined by a CDAI score of at least 220 at baseline.

• Have a centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥6 for patients with ileal-colonic or ≥4 for patients with isolated ileal disease within 21 days before the first dose of study treatment.

• Have a history of CD involving only or predominantly the colon for greater than or equal to 8 years with a surveillance colonoscopy within 1 year prior to baseline must have documented negative results for colorectal dysplasia and cancer.

• Have an inadequate response to, loss of response to, or intolerance to:

  • at least one conventional therapy (such as corticosteroids, oral azathioprine (AZA) or 60-mercaptopurine (6-MP), or oral aminosalicylates (for example, mesalamine, sulfasalazine, olsalazine, balsalazide) and/or,
  • at least one advanced therapy for CD (defined as: a biologic or biosimilar medication such as anti-tumor necrosis factor (TNF) antibodies, anti-integrin antibodies, Janus kinase (JAK) inhibitors such as upadacitinib, or anti-interleukin (IL)-12p40 antibodies, for example, ustekinumab).

Exclusion Criteria

• Have a current diagnosis of Ulcerative Colitis (UC), inflammatory bowel disease-unclassified (formerly known as indeterminate colitis), or primary sclerosing cholangitis.
• Have more than 2 missing segments of the following 5 segments: terminal ileum, ·right colon, transverse colon, ·left colon, and rectum.
• Currently have or are suspected to have an abscess.
• Have a stoma, ileoanal pouch, or ostomy.
• Have a history of more than 3 small bowel resections, diagnosis of short bowel syndrome, or any intestinal or non-intestinal intra-abdominal surgery within 3 months of baseline.
• 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 had more than 5% body weight change in the past 3 months
• 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 by Crohn's Disease Activity Index (CDAI), Endoscopic Remission, and at least 10% Weight Reduction	Week 52	Percentage of participants who simultaneously achieve clinical remission by CDAI, endoscopic remission and at least 10% weight reduction.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ)	Baseline, Week 52	Change from baseline in inflammatory bowel disease questionnaire (IBDQ).
Percentage of Participants Who Simultaneously Achieve Clinical Remission by CDAI and Endoscopic Remission	Week 52	Percentage of participants who simultaneously achieve clinical remission by CDAI and endoscopic remission.
Percentage of Participants Who Achieved Maintenance of Clinical Remission by CDAI	Week 52	Percentage of participants who achieve maintenance of clinical remission by CDAI.
Percentage of Participants Who Achieved Maintenance of Endoscopic Remission	Week 52	Percentage of participants who achieve maintenance of endoscopic remission.
Percentage of Participants Who Achieve at Least a 10% Reduction in Body Weight	Week 52	Percentage of participants who achieve at least a 10% reduction in body weight.
Percentage of Participants Who Achieve Corticosteroid-free Clinical Remission by CDAI Among Participants Who Used Corticosteroids at Baseline	Week 52	Percentage of participants who achieve corticosteroid-free clinical remission by CDAI among participants who used corticosteroids at baseline.

Trial Locations

Locations (186)

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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