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CompletedNCT06475729Updated Dec 30, 2025Results posted

A Bioequivalence Study of Citrate Free Mirikizumab (LY3074828) in Healthy Participants

A Phase 1 interventional study of Citrate-Free Mirikizumab in Healthy, sponsored by Eli Lilly and Company. Completed at 6 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-30.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
498
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the amount of mirikizumab (test) that gets into the blood stream and how long it takes the body to get rid of it, when given via autoinjector, an injection under the skin, compared to mirikizumab (reference) solution given via autoinjector.

Screening is required within 35 days prior to enrollment. For each participant, the total duration for of the clinical trial will be about 15 weeks, including screening.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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: participants may have chronic, stable medical conditions that, in the investigator's opinion, will not place the participant at increased risk by participating in the study, and will not interfere with interpretation of the data.

  2. Have clinical laboratory test results:

    • Within normal reference range for the population, or
    • Within normal reference range for the investigative site, or
    • Results with acceptable deviations that are judged to be not clinically significant by the investigator.

    Weight

  3. Have a body mass index (BMI) within the range of 18.0 to 34.0 kilograms per milligram squared (km/m\^2), inclusive.

Exclusion criteria

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

Medical conditions

  1. Have significant allergies to humanized monoclonal antibodies or known allergies to citrate-free mirikizumab, related compounds or any components of the formulation.
  2. Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data.
  3. Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions.
  4. Have a diagnosis or history of malignant disease within 5 years prior to baseline.

    Prior/concomitant therapy

  5. Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing.
  6. Have received treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, within 3 months or 5 half-lives, whichever is longer, prior to dosing.
  7. Have ever received anti-interleukin (IL)-12p40 antibodies or anti-IL-23p19 antibodies, for any indication, including investigational use.
  8. Have received any live vaccine (that is, live attenuated) within less than 4 weeks or inactivated vaccine within less than 2 weeks before randomization.

    Prior/concurrent clinical study experience

  9. Are currently enrolled in a clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
  10. Have participated in a clinical study involving an investigational product within the last 30 days or 5 half-lives, whichever is longer, prior to screening. If the clinical trial involved treatment with biologic agents, such as monoclonal antibodies, including marketed drugs, at least 3 months or 5 half-lives, whichever is longer, should have elapsed prior to dosing.
  11. Have previously completed or withdrawn from this study or any other study investigating mirikizumab, and have previously received mirikizumab.

    Diagnostic assessments

  12. Have a current infection with hepatitis C virus.
  13. Have a current infection with hepatitis B virus.
  14. Have a current or recent acute, active infection.
  15. Have had any of the following types of infection within 3 months prior to screening or develops any of these infections before the randomization:

    1. Serious: Requiring hospitalization, or intravenous (IV) or equivalent oral antibiotic treatment, or both.
    2. Opportunistic: As defined in Winthrop et al. 2015. Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over.
    3. Chronic: Duration of symptoms, signs, and/or treatment of 6 weeks or longer.
    4. Recurring: Including, but not limited to, herpes simplex, herpes zoster, recurring cellulitis, chronic osteomyelitis.
  16. Show evidence of active or latent tuberculosis (TB).

    Other exclusion criteria

  17. Have alcohol intake that exceeds recommended average weekly alcohol consumption limits per local regulation, or an amount deemed significant by the investigator.
  18. Smoke more than 10 cigarettes per day, or equivalent, or are unable to abide by investigative site smoking restrictions.
  19. In the opinion of the investigator or sponsor, are unsuitable for inclusion in the study.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
498 participants (actual)

Study arms

  • Experimental
    200 mg Mirikizumab (Test)

    Participants 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.

    Drug: Citrate-Free Mirikizumab

  • Experimental
    200 mg Mirikizumab (Reference)

    Participants 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.

    Drug: Citrate-Free Mirikizumab

Interventions

  • DrugCitrate-Free Mirikizumab

    Administered SC

    Also known as: LY3074828

06

What researchers measure

Primary outcomes

  1. Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab

    Cmax of Mirikizumab is reported.

    Time frame: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

  2. PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab

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

    Time frame: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

  3. PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab

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

    Time frame: Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.

07

Results

Posted Dec 30, 2025

Participant flow

Participant flow — Overall Study
Milestone200 mg Mirikizumab (Reference)200 mg Mirikizumab (Test)
Started249249
All participants who were exposed to study intervention (safety population)240244
Completed237241
Not completed128
Withdrew: Withdrawal by subject21
Withdrew: Randomized but did not receive any dose32
Withdrew: Lost to follow-up12
Withdrew: Physician decision52
Withdrew: Adverse event11

Outcome measures

PrimaryPharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab

Cmax of Mirikizumab is reported.

Time frame:
Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
Reported as:
Geometric mean · microgram per milliliter (ug/mL)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab
microgram per milliliter (ug/mL)200 mg Mirikizumab (Reference)200 mg Mirikizumab (Test)
Pharmacokinetics (PK): Maximum Observed Drug Concentration (Cmax) of Mirikizumab12.9 ± 4013.5 ± 39
Statistical analysis
  • 200 mg Mirikizumab (Reference) vs 200 mg Mirikizumab (Test) · Ratio of geometric least squares mean: 1.039 · 90% CI 0.9853 to 1.0956
PrimaryPK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab

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

Time frame:
Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
Reported as:
Geometric mean · microgram*day per milliliter (ug*day/mL)
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab
microgram*day per milliliter (ug*day/mL)200 mg Mirikizumab (Reference)200 mg Mirikizumab (Test)
PK: Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of Mirikizumab225 ± 41228 ± 41
Statistical analysis
  • 200 mg Mirikizumab (Reference) vs 200 mg Mirikizumab (Test) · Ratio of geometric least squares mean: 1.011 · 90% CI 0.9564 to 1.0685
PrimaryPK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab

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

Time frame:
Day 1: Predose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704 hours post-dose.
Reported as:
Geometric mean · microgram*day per milliliter (ug*day/mL)
PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab
microgram*day per milliliter (ug*day/mL)200 mg Mirikizumab (Reference)200 mg Mirikizumab (Test)
PK: Area Under the Concentration Versus Time Curve From Time 0 to the Last Measurable Concentration (AUC [0-tlast]) of Mirikizumab220 ± 40223 ± 41
Statistical analysis
  • 200 mg Mirikizumab (Reference) vs 200 mg Mirikizumab (Test) · Ratio of geometric least squares mean: 1.011 · 90% CI 0.9568 to 1.0678

Adverse events

Collected over Baseline up to Day 74. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
200 mg Mirikizumab (Reference)0/240 (0%)0/240 (0%)55/240 (22.9%)
200 mg Mirikizumab (Test)0/244 (0%)0/244 (0%)48/244 (19.7%)
Most frequent other events
Showing 10 of 80
Most frequent other events
Event200 mg Mirikizumab (Reference)200 mg Mirikizumab (Test)
HeadacheNervous system disorders9/24012/244
Injection site reactionGeneral disorders4/2405/244
Upper respiratory tract infectionInfections and infestations4/2401/244
Back painMusculoskeletal and connective tissue disorders4/2400/244
NauseaGastrointestinal disorders3/2402/244
PharyngitisInfections and infestations3/2402/244
HyperkalaemiaMetabolism and nutrition disorders3/2402/244
RhinorrhoeaRespiratory, thoracic and mediastinal disorders3/2400/244
DiarrhoeaGastrointestinal disorders2/2402/244
VomitingGastrointestinal disorders2/2400/244

Baseline characteristics

All participants who were exposed to study intervention (Safety Population).

Age, Continuous
Age, Continuous(years)200 mg Mirikizumab (Reference)200 mg Mirikizumab (Test)Total
Mean42.7 ± 11.642.4 ± 12.542.5 ± 12.1
Sex: Female, Male
Sex: Female, Male(Participants)200 mg Mirikizumab (Reference)200 mg Mirikizumab (Test)Total
Female112135247
Male128109237
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)200 mg Mirikizumab (Reference)200 mg Mirikizumab (Test)Total
Hispanic or Latino111108219
Not Hispanic or Latino129136265
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)200 mg Mirikizumab (Reference)200 mg Mirikizumab (Test)Total
American Indian or Alaska Native011
Asian81018
Native Hawaiian or Other Pacific Islander011
Black or African American5256108
White177174351
More than one race325
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)200 mg Mirikizumab (Reference)200 mg Mirikizumab (Test)Total
United States240244484
08

Study locations

6 sites
  • CenExel ACT
    Anaheim, California 92801, United States
  • Fortrea Clinical Research Unit
    Daytona Beach, Florida 32117, United States
  • Clinical Pharmacology of Miami
    Miami, Florida 33014-3616, United States
  • QPS Missouri
    Springfield, Missouri 65802, United States
  • Fortrea Clinical Research Unit
    Dallas, Texas 75247, United States
  • Fortrea Clinical Research Unit
    Madison, Wisconsin 53704, United States
09

References and documents

Publications

  • Otani Y, Payne CD, Loftus EV Jr, D'Haens G, Ben Horin S, Upadhya K A, Todd K, Pellanda P, Shi G, Zhang X. One Subcutaneous 2-ml Injection of Mirikizumab is Bioequivalent to Two 1-ml Subcutaneous Injections in Healthy Participants. Adv Ther. 2026 Jan;43(1):377-389. doi: 10.1007/s12325-025-03422-1. Epub 2025 Nov 28. PubMed 41313544 ↗

Study documents

  • Study protocol · Sep 24, 2024
  • Statistical analysis plan · Jun 6, 2024

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT06475729
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
Jun 26, 2024
Start date
Jun 24, 2024
Primary completion
Dec 27, 2024
Completion
Dec 27, 2024
Results posted
Dec 30, 2025
Last update
Dec 30, 2025

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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