CompletedNCT05069896Updated Mar 4, 2025Results posted

A Study to Compare Two Formulations of Mirikizumab (LY3074828) in Healthy Participants

A Phase 1 interventional study of Mirikizumab Prefilled Syringe and Mirikizumab Autoinjector in Healthy, sponsored by Eli Lilly and Company. Completed at 3 sites in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-04.

Sponsored by Eli Lilly and Company · Phase 1, Interventional, and Basic science

Phase: Phase 1
Study type: Interventional
Enrollment: 237
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

The main purpose of this study is to compare the amount of mirikizumab that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via manual prefilled syringe or autoinjector. The information about any adverse effects experienced will be collected and the tolerability of mirikizumab will also be evaluated.

Screening is required within 28 days prior to the enrolment. For each participant, the total duration of the clinical trial will be about 17 weeks including screening.

Conditions studied

Healthy

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.

Who can participate

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

Inclusion criteria

Are overtly healthy males or non-pregnant females of childbearing or non-childbearing potential
Have body mass index (BMI) within the range 18.0 to 32.0 kg/m2 (inclusive)

Exclusion criteria

Exclusion Criteria:

Must not show evidence of active or latent tuberculosis (TB)
Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 8 weeks of screening, or intend to during the study
Must not have been treated with steroids within 1 month of screening, or intend to during the study
Must not have had a serious infection, or have been hospitalized or have received IV antibiotics for an infection within 12 weeks prior to Day 1
Must not be immunocompromised
Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to Day 1
Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post treatment hypersensitivity reactions
Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
Must not have had breast cancer within the past 10 years
Must not have significant allergies to humanized monoclonal antibodies

Study design

Phase: Phase 1
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 237 participants (actual)

Study arms

Experimental
Mirikizumab - Prefilled Syringe
Participants received 3 milliliter (mL) mirikizumab as 2 subcutaneous (SC) injections of 1 mL and 2 mL delivered via a prefilled syringe (PFS) to abdomen or arms or thighs.
Drug: Mirikizumab Prefilled Syringe
Experimental
Mirikizumab - Autoinjector
Participants received 3 mL mirikizumab as 2 SC injections of 1 mL and 2 mL delivered an autoinjector (AI) to abdomen or arms or thighs.
Drug: Mirikizumab Autoinjector

Interventions

DrugMirikizumab Prefilled Syringe
Administered SC by prefilled syringe
Also known as: LY3074828
DrugMirikizumab Autoinjector
Administered SC by autoinjector
Also known as: LY3074828

What researchers measure

Primary outcomes

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab Administered by PFS and AI
PK: Cmax of Mirikizumab administered by PFS and AI.
Time frame: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab Administered by PFS and AI
PK: AUC\[0-∞\] of Mirikizumab administered by PFS and AI.
Time frame: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab Administered by PFS and AI
PK: AUC\[0-tlast\] of Mirikizumab administered by PFS and AI.
Time frame: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose

Results

Posted Mar 4, 2025

Participant flow

Participant flow — Overall Study
Milestone	Mirikizumab Pre-filled Syringe (PFS) - Abdomen	Mirikizumab PFS - Arm	Mirikizumab PFS - Thigh	Mirikizumab Autoinjector (AI) - Abdomen	Mirikizumab AI - Arm	Mirikizumab AI - Thigh
Started	39	39	39	40	40	40
Received at least one dose of study drug	39	39	39	40	40	40
Completed	39	38	37	40	39	38
Not completed	0	1	2	0	1	2
Withdrew: Adverse event	0	1	1	0	0	0
Withdrew: Lost to follow-up	0	0	1	0	1	2

Outcome measures

PrimaryPharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab Administered by PFS and AI

PK: Cmax of Mirikizumab administered by PFS and AI.

Time frame:: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose
Reported as:: Geometric mean · micrograms per milliliter (μg/mL)

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab Administered by PFS and AI
micrograms per milliliter (μg/mL)	Mirikizumab PFS	Mirikizumab AI
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Mirikizumab Administered by PFS and AI	20.0 ± 44	23.5 ± 40

PrimaryPK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab Administered by PFS and AI

PK: AUC\[0-∞\] of Mirikizumab administered by PFS and AI.

Time frame:: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose
Reported as:: Geometric mean · microgram*day per milliliter (μg*day/mL)

PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab Administered by PFS and AI
microgramday per milliliter (μgday/mL)	Mirikizumab PFS	Mirikizumab AI
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Mirikizumab Administered by PFS and AI	359 ± 44	412 ± 39

PrimaryPK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab Administered by PFS and AI

PK: AUC\[0-tlast\] of Mirikizumab administered by PFS and AI.

Time frame:: Pre-dose, 72, 120, 192, 264, 360, 528, 696, 1032, 1368, 1704, 2040 hours post day 1 dose
Reported as:: Geometric mean · microgram*day per milliliter (μg*day/mL)

PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab Administered by PFS and AI
microgramday per milliliter (μgday/mL)	Mirikizumab PFS	Mirikizumab AI
PK: Area Under the Plasma Concentration Versus Time Curve From Time Zero to the Last Measured Concentration Value (AUC[0-tlast]) of Mirikizumab Administered by PFS and AI	355 ± 44	411 ± 38

Adverse events

Collected over Baseline up to 88 days.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Mirikizumab PFS - Abdomen	0/39 (0%)	0/39 (0%)	8/39 (20.5%)
Mirikizumab PFS - Arm	0/39 (0%)	0/39 (0%)	13/39 (33.3%)
Mirikizumab PFS - Thigh	0/39 (0%)	0/39 (0%)	8/39 (20.5%)
Mirikizumab AI - Abdomen	0/40 (0%)	1/40 (2.5%)	13/40 (32.5%)
Mirikizumab AI - Arm	0/40 (0%)	0/40 (0%)	9/40 (22.5%)
Mirikizumab AI - Thigh	0/40 (0%)	0/40 (0%)	9/40 (22.5%)

Most frequent serious events

Most frequent serious events
Event	Mirikizumab PFS - Abdomen	Mirikizumab PFS - Arm	Mirikizumab PFS - Thigh	Mirikizumab AI - Abdomen	Mirikizumab AI - Arm	Mirikizumab AI - Thigh
Abortion spontaneousPregnancy, puerperium and perinatal conditions	0/19	0/25	0/22	1/21	0/29	0/22

Most frequent other events

Showing 10 of 14

Most frequent other events
Event	Mirikizumab PFS - Abdomen	Mirikizumab PFS - Arm	Mirikizumab PFS - Thigh	Mirikizumab AI - Abdomen	Mirikizumab AI - Arm	Mirikizumab AI - Thigh
HeadacheNervous system disorders	4/39	6/39	2/39	1/40	3/40	4/40
Injection site reactionGeneral disorders	0/39	1/39	1/39	6/40	5/40	1/40
COVID-19Infections and infestations	1/39	3/39	3/39	4/40	4/40	2/40
CoughRespiratory, thoracic and mediastinal disorders	0/39	3/39	0/39	1/40	1/40	2/40
RhinorrhoeaRespiratory, thoracic and mediastinal disorders	0/39	3/39	0/39	1/40	0/40	0/40
Nasal congestionRespiratory, thoracic and mediastinal disorders	0/39	2/39	0/39	0/40	1/40	3/40
DiarrhoeaGastrointestinal disorders	1/39	2/39	0/39	2/40	1/40	0/40
NauseaGastrointestinal disorders	0/39	2/39	2/39	1/40	1/40	0/40
VomitingGastrointestinal disorders	2/39	1/39	0/39	0/40	1/40	1/40
FatigueGeneral disorders	0/39	0/39	2/39	0/40	1/40	1/40

Baseline characteristics

All participants who received at least one dose of mirikizumab.

Age, Continuous
Age, Continuous(years)	Mirikizumab PFS - Abdomen	Mirikizumab PFS - Arm	Mirikizumab PFS - Thigh	Mirikizumab AI - Abdomen	Mirikizumab AI - Arm	Mirikizumab AI - Thigh	Total
Mean	42.7 ± 12.7	39.2 ± 11.6	42.5 ± 13.2	42.1 ± 14.4	42.6 ± 13.0	39.1 ± 12.8	41.3 ± 12.9

Sex: Female, Male
Sex: Female, Male(Participants)	Mirikizumab PFS - Abdomen	Mirikizumab PFS - Arm	Mirikizumab PFS - Thigh	Mirikizumab AI - Abdomen	Mirikizumab AI - Arm	Mirikizumab AI - Thigh	Total
Female	19	25	22	21	29	22	138
Male	20	14	17	19	11	18	99

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Mirikizumab PFS - Abdomen	Mirikizumab PFS - Arm	Mirikizumab PFS - Thigh	Mirikizumab AI - Abdomen	Mirikizumab AI - Arm	Mirikizumab AI - Thigh	Total
Hispanic or Latino	6	4	13	8	9	8	48
Not Hispanic or Latino	33	35	26	32	31	32	189
Unknown or Not Reported	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Mirikizumab PFS - Abdomen	Mirikizumab PFS - Arm	Mirikizumab PFS - Thigh	Mirikizumab AI - Abdomen	Mirikizumab AI - Arm	Mirikizumab AI - Thigh	Total
American Indian or Alaska Native	0	0	0	0	0	0	0
Asian	2	1	0	0	3	1	7
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0
Black or African American	4	5	5	4	8	3	29
White	32	33	33	35	29	36	198
More than one race	1	0	1	1	0	0	3
Unknown or Not Reported	0	0	0	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	Mirikizumab PFS - Abdomen	Mirikizumab PFS - Arm	Mirikizumab PFS - Thigh	Mirikizumab AI - Abdomen	Mirikizumab AI - Arm	Mirikizumab AI - Thigh	Total
United States	39	39	39	40	40	40	237

Study locations

3 sites

LabCorp CRU, Inc.
Daytona Beach, Florida 32117, United States
QPS
Springfield, Missouri 65802, United States
Covance Dallas
Dallas, Texas 75247, United States

References and documents

Study documents

Study protocol · Aug 11, 2021
Statistical analysis plan · Sep 28, 2021

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

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Mar 4, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05069896
Lead sponsor: Eli Lilly and Company
Responsible party: Sponsor
First posted: Oct 6, 2021
Start date: Oct 5, 2021
Primary completion: Jun 22, 2022
Completion: Jun 22, 2022
Results posted: Mar 4, 2025
Last update: Mar 4, 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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