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Mirikizumab with or without tirzepatide for adults with moderately to severely active Crohn's disease who are overweight or have obesity

A Phase 3b, Randomized, Multicenter, Controlled Study of Mirikizumab and Placebo or Mirikizumab Concomitantly Administered With Tirzepatide in Adult Participants With Moderately to Severely Active Crohn's Disease and Obesity or Overweight

PHASE3 · Eli Lilly and Company · NCT06937099

This trial tests whether adding tirzepatide to mirikizumab helps adults with moderately to severely active Crohn's disease who are overweight or have obesity.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment290 (estimated)
Ages18 Years to 70 Years
SexAll
SponsorEli Lilly and Company (industry)
Drugs / interventionsmirikizumab
Locations187 sites (Dothan, Alabama and 186 other locations)
Trial IDNCT06937099 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares mirikizumab plus placebo to mirikizumab with concomitant tirzepatide in adults who have moderately to severely active Crohn's disease and are overweight or have obesity. Eligible participants must meet clinical activity (CDAI ≥220) and endoscopic (SES-CD) thresholds and will be treated and followed for up to 61 weeks. Study procedures include scheduled administration of mirikizumab with either tirzepatide or matching placebo, central endoscopic reads, and regular safety and efficacy assessments including disease activity and weight-related outcomes. The trial is designed to measure both Crohn's disease response and safety while also observing effects on weight and metabolic comorbidities.

Who should consider this trial

Good fit: Adults with moderately to severely active Crohn's disease (CDAI ≥220), a qualifying SES-CD score, and BMI ≥30 kg/m² or BMI 27–<30 kg/m² with at least one weight‑related comorbidity are ideal candidates.

Not a fit: People with mild Crohn's disease (CDAI <220), those who are not overweight or obese, or those with contraindications to biologics or GLP/GIP receptor agonists are unlikely to benefit from this study intervention.

Why it matters

Potential benefit: If successful, adding tirzepatide to mirikizumab could improve Crohn's disease control while also reducing weight and related metabolic risks in overweight or obese patients.

How similar studies have performed: IL‑23–targeting biologics have shown benefit in Crohn's disease and tirzepatide is proven for weight loss, but combining mirikizumab with tirzepatide in Crohn's disease is a novel approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have a confirmed diagnosis of Crohn's disease (CD) or perianal fistulizing CD
* 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 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.
* Participants with a history of CD for ≥8 years involving only or predominantly the colon must have documented negative results for colorectal dysplasia and cancer within 1 year prior to baseline.
* Demonstrated inadequate response, loss of response or intolerance to at least one protocol-specified conventional or advanced CD therapy

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, total resection of small bowel greater than 100 centimeters (cm), 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.

Where this trial is running

Dothan, Alabama and 186 other locations

+137 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Crohn's Disease, Obesity or Overweight

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.