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Free Mirikizumab

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Dec 30, 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment498

FDA Designations

No designations recorded

Clinical trial landscape

Free Mirikizumab · 1 trial · 1 indication

Phase 1 1
NCT06475729A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy ParticipantsHealthy
COMPLETED498 Analytics
PHASE1COMPLETED
A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab
Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

Cmax of Mirikizumab is reported.

PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab
Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

AUC \[0-∞\] of Mirikizumab is reported.

PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab
Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

AUC \[0 to tlast\] of Mirikizumab is reported.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
200 mg Mirikizumab (Test)EXPERIMENTALParticipants received 200 mg mirikizumab test formulation, 1 × 2-mL SC injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.
200 mg Mirikizumab (Reference)EXPERIMENTALParticipants received 200 milligrams (mg) mirikizumab reference formulation, 2 × 1-milliliter (mL) subcutaneous (SC) injections of 100 mg/mL citrate-free mirikizumab administered into arm/thigh/abdomen on day 1.

Interventions

NameTypeDescription
Citrate-Free MirikizumabDRUGAdministered SC
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: Type of participant and disease characteristics 1. Overtly healthy males and females as determined by medical evaluation including: * Medical history, * Physical examination, * Clinical laboratory tests, * Electrocardiogram (ECG), * Vital signs Note: partici...

Countries:United States
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Frequently asked questions about Free Mirikizumab

What is Free Mirikizumab used for?

Free Mirikizumab is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development for use in healthy individuals, as part of a bioequivalence study. The drug is being developed by Eli Lilly and Company.

Who makes Free Mirikizumab?

Free Mirikizumab is being developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The drug is currently in Phase 1 clinical development for use in healthy participants.

What phase is Free Mirikizumab in?

Free Mirikizumab is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still undergoing clinical trials. The drug is being studied in healthy participants as part of a bioequivalence study.

What clinical trials is Free Mirikizumab in?

Free Mirikizumab is associated with one completed clinical trial, NCT06475729, titled 'A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants.' This Phase 1 trial enrolled 498 healthy participants in the United States and has been completed.

Is Free Mirikizumab the same as LY3074828?

Yes, Free Mirikizumab is also known as LY3074828. The clinical trial NCT06475729, which studies Free Mirikizumab, is titled 'A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants,' confirming that these names refer to the same drug.