A Study of LY4395089 and Mirikizumab (LY3074828) Given Together and Mirikizumab (Alone) in Adults With Crohn's Disease

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT07483099
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • LY4395089 — DRUG
    Administered orally
  • Mirikizumab - Intravenous (IV) — DRUG
    Administered IV
  • Mirikizumab - Subcutaneous (SC) — DRUG
    Administered SC

Study Details

The main purpose of this study is to see how the safety and efficacy of a farnesoid X receptor (FXR) agonist (LY4395089), given together with mirikizumab compares with mirikizumab (alone) in adults with moderately to severely active Crohn's disease (CD). This study is part of the IIBD master protocol and will last approximately 62 weeks.

Key Dates

Start date
May 4, 2026
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Mirikizumab
    Study Period 1: Mirikizumab administered via IV. Study Period 2: Responders will receive mirikizumab SC.
  • Experimental: LY4395089 and Mirikizumab Co-Administration
    Study Period 1: Co-administration of LY4395089 administered orally and mirikizumab administered IV. Study Period 2: Responders will stop LY4395089 and receive mirikizumab SC.

Primary Outcome Measure

Percentage of Participants with Crohn's Disease who Achieve Endoscopic Response [ Time Frame: Baseline, Up to Week 12 ]

Central Contacts

  • There may be multiple sites in this clinical trial. (Add "This 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]

Locations (15)

FacilityCityStateZIPSite coordinators
Mayo Clinic in Arizona - ScottsdaleScottsdaleArizona85259
Manreet Kaur (PRINCIPAL_INVESTIGATOR)
Biopharma Informatic, LLCLos AngelesCalifornia90035
Morris Silver, MD (PRINCIPAL_INVESTIGATOR)
Om Research LLCOxnardCalifornia93030
Karen Simon (PRINCIPAL_INVESTIGATOR)
South Denver GastroenterologyEnglewoodColorado80113
Marcelo Kugelmas (PRINCIPAL_INVESTIGATOR)
Gastro Health Research - MiamiMiamiFlorida33176
Lukasz Kwapisz (PRINCIPAL_INVESTIGATOR)
Ezy Medical ResearchMiami LakesFlorida33015
Hendry Perez-Pascual (PRINCIPAL_INVESTIGATOR)
Atlanta Gastroenterology Associates - Peachtree DunwoodyAtlantaGeorgia30342
Nitin Gupta (PRINCIPAL_INVESTIGATOR)
Rush University Medical CenterChicagoIllinois60612
Atsushi Sakuraba (PRINCIPAL_INVESTIGATOR)
Cotton O'Neil Digestive Health CenterTopekaKansas66606
Curtis Baum (PRINCIPAL_INVESTIGATOR)
Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research CenterWyomingMichigan49519
Allan Coates (PRINCIPAL_INVESTIGATOR)
KAD Clinical ResearchSt LouisMissouri63123
Adrian Di Bisceglie (PRINCIPAL_INVESTIGATOR)
Vector Clinical TrialsLas VegasNevada89128
Christian Stone (PRINCIPAL_INVESTIGATOR)
Innovo Research - Wilmington Gastroenterology AssociatesWilmingtonNorth Carolina28403
William King (PRINCIPAL_INVESTIGATOR)
One of a Kind Clinical Research Center - KingwoodKingwoodTexas77339
Sushovan Guha (PRINCIPAL_INVESTIGATOR)
Southern Star Research InstituteSan AntonioTexas78229
Jeff Bullock (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scottsdale, AZ

By condition
Crohn's disease
By specialty
GastroenterologyInflammatory bowel diseaseAutoimmune disease
By research site
Mayo Clinic in Arizona - Scottsdale· Scottsdale, AZBiopharma Informatic, LLC· Los Angeles, CAOm Research LLC· Oxnard, CASouth Denver Gastroenterology· Englewood, COGastro Health Research - Miami· Miami, FLEzy Medical Research· Miami Lakes, FL

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