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Healthy volunteers help test simpler injection for mirikizumab

NCT ID NCT07446101

Knowledge-focused Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study in 450 healthy volunteers checks if a single injection of mirikizumab works as well as two separate shots. The main goal is to see how the body handles the drug and to ensure safety. Participants will be monitored for about 15 weeks with blood tests and check-ups.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
mirikizumab

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 450 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Are overtly healthy males or females as determined by medical evaluation including: * medical history * physical examination * clinical laboratory tests * ECG, and * vital signs. * Have clinical laboratory test results at screening and Day -1 within normal reference range. * Have a body mass index (BMI) within the range of 18.0 to 34.0 kilograms per square meter (kg/m²), inclusive. Exclusion Criteria: * Have significant allergies to humanized monoclonal antibodies or known allergies to mirikizumab, related compounds or any components of the formulation, or history of significant atopy. * Have significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs. * Have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions. * Are immunocompromised. * Intend to use over-the-counter or prescription medication, including herbal medications and traditional medications, within 7 days prior to dosing. * Have received treatment with biologic agents within 3 months or 5 half-lives, whichever is longer, prior to dosing. * Have previously received mirikizumab. * Have an abnormality in the 12-lead electrocardiogram (ECG). * Have clinically significant abnormalities in blood pressure, pulse rate, or body temperature. * Have a current or recent acute, active infection. * Have active tuberculosis (TB), or any history of active TB.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Healthy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Axis Clinicals LLC

    RECRUITING

    Dilworth, Minnesota, 56529, United States

  • Fortrea Clinical Research Unit

    RECRUITING

    Daytona Beach, Florida, 32117, United States

  • Fortrea Clinical Research Unit

    RECRUITING

    Dallas, Texas, 75247, United States

  • Fortrea Clinical Research Unit

    RECRUITING

    Madison, Wisconsin, 53704, United States

  • Worldwide Clinical Trials, Inc.

    RECRUITING

    San Antonio, Texas, 78217, United States

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