290 Participants Needed

Mirikizumab + Tirzepatide for Crohn's Disease

(COMMIT-CD Trial)

Recruiting at 191 trial locations
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Overseen ByThere may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eli Lilly and Company
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, it mentions that participants should have had an inadequate response to or intolerance to certain conventional or advanced therapies for Crohn's Disease.

What safety data exists for Mirikizumab and Tirzepatide in humans?

Mirikizumab has been studied for safety in conditions like psoriasis, ulcerative colitis, and Crohn's disease, showing it is generally safe for humans. However, there is no specific safety data available for Tirzepatide in the context of Crohn's disease from the provided research articles.12345

How is the drug combination of Mirikizumab and Tirzepatide unique for treating Crohn's disease?

The combination of Mirikizumab and Tirzepatide for Crohn's disease is unique because Mirikizumab is a monoclonal antibody that targets interleukin-23, a protein involved in inflammation, and has shown effectiveness in other inflammatory conditions like psoriasis and ulcerative colitis. This combination may offer a novel approach by potentially addressing both inflammation and metabolic aspects of Crohn's disease, although Tirzepatide's role in this context is less clear from the available data.12367

What data supports the effectiveness of the drug Mirikizumab for Crohn's Disease?

Research shows that Mirikizumab, which targets a protein involved in inflammation, has been effective in treating conditions like psoriasis and ulcerative colitis, and has shown promise in a study for Crohn's disease.12689

Who Is on the Research Team?

CL

Contact Lilly at 1-800-LillyRx (1-800-545-5979)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

Adults with moderate to severe Crohn's Disease who are also overweight or obese can join this trial. Specific details about what makes someone eligible or not weren't provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

I was diagnosed with Crohn's disease or perianal fistulizing CD over 3 months ago.
My Crohn's disease severity score is high enough for the study.
My Crohn's disease is moderate to severe.
See 3 more

Exclusion Criteria

I have more than 2 parts of my colon or rectum missing.
I might have an abscess.
I've had severe low blood sugar or didn't notice it happening in the last 6 months.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive mirikizumab and placebo or mirikizumab with tirzepatide for Crohn's Disease and obesity or overweight

52 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Mirikizumab
  • Tirzepatide
Trial Overview The trial is testing if Mirikizumab alone or combined with Tirzepatide is effective and safe for treating Crohn's Disease in adults who are overweight. Some will get a placebo instead of Tirzepatide to compare results. The study lasts up to 61 weeks.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Mirikizumab + TirzepatideExperimental Treatment2 Interventions
Mirikizumab administered intravenously (IV) then Mirikizumab administered subcutaneously (SC). Tirzepatide administered SC.
Group II: Mirikizumab + PlaceboExperimental Treatment2 Interventions
Mirikizumab administered IV then Mirikizumab administered SC. Placebo administered SC.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Published Research Related to This Trial

In a study of 191 patients with moderate-to-severe Crohn's disease, mirikizumab significantly improved endoscopic response at Week 12 compared to placebo, with the highest response rate observed in the 1000 mg group (43.8%).
Mirikizumab demonstrated durable efficacy, maintaining a high endoscopic response rate of around 58.5% at Week 52, while the safety profile was comparable to placebo, indicating it is a promising treatment option for Crohn's disease.
Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Crohn's Disease.Sands, BE., Peyrin-Biroulet, L., Kierkus, J., et al.[2022]
In a study of 100 patients with moderate-to-severe Crohn's disease who had previously failed multiple treatments, risankizumab achieved a steroid-free clinical remission rate of 45.8% and a clinical response rate of 78.5% by week 12, indicating its effectiveness in a real-world setting.
The treatment was generally well-tolerated, with 20 adverse events reported, including 7 serious cases, but the majority of patients experienced significant improvements in their condition, highlighting risankizumab's potential as a viable option for refractory Crohn's disease.
Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn's disease: A GETAID multicentre cohort study.Fumery, M., Defrance, A., Roblin, X., et al.[2023]
Azathioprine (AZA) and its metabolite 6-mercaptopurine (6-MP) are effective for treating active Crohn's disease and preventing relapses in patients in remission, but they require combination with other medications initially due to delayed onset of action.
While AZA/6-MP therapy is generally effective, about 15% of patients experience side effects such as skin rash and increased risk of infections, necessitating careful monitoring and potential dose adjustments.
Azathioprine: an update on clinical efficacy and safety in inflammatory bowel disease.Lamers, CB., Griffioen, G., van Hogezand, RA., et al.[2019]

Citations

Efficacy and Safety of Mirikizumab in a Randomized Phase 2 Study of Patients With Crohn's Disease. [2022]
Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn's disease: A GETAID multicentre cohort study. [2023]
Azathioprine: an update on clinical efficacy and safety in inflammatory bowel disease. [2019]
Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis. [2023]
Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. [2023]
Risankizumab as induction therapy for Crohn's disease: results from the phase 3 ADVANCE and MOTIVATE induction trials. [2022]
Assessment of the real-world safety profile of vedolizumab using the United States Food and Drug Administration adverse event reporting system. [2023]
Characterizing Adverse Events of Biologic Treatment of T2 Disease: A Disproportionality Analysis of the FDA Adverse Event Reporting System. [2023]
Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease. [2023]
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