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Breastfeeding moms needed for drug safety study

NCT ID NCT07612267

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 09, 2026 · Updated 5 times

Summary

This study will measure how much of the drug mirikizumab passes into breast milk in 14 breastfeeding women who take it for inflammatory bowel disease. Participants will provide milk samples over several weeks. The goal is to understand potential exposure to nursing infants, helping guide safer use during breastfeeding.

What this could mean

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

Active substance
mirikizumab
What this could lead to
If successful, this study will help doctors understand whether mirikizumab is safe for breastfeeding infants, guiding treatment decisions for nursing mothers.
What could go wrong
This is a small, early-phase study with only 14 participants, so results may not apply to all women. It measures drug levels in milk, not infant health outcomes directly.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 14 people

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

Started

Aug 2026

Expected to finish

Sep 2028

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

3 weeks and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: Study Participants: * Mothers who are at minimum 18 years of age and their infants who are at least 36 weeks gestation age at birth and at least 3 weeks old by Study Day 0 * Multiple births may be allowed following discussion with the medical monitor. Note: in the opinion of the healthcare practitioner (HCP), there are no infant or maternal issues that would preclude the mother participant or the infant from participation * Lactation history is well established, with the mother exclusively breastfeeding her infant * Mother participant is receiving mirikizumab therapeutically for an approved diagnosis (having received at least 2 doses of mirikizumab SC maintenance therapy every 4 weeks prior to study Day 0) * Have a breastfed infant who can feed from a bottle with previously stored breast milk or formula Exclusion Criteria: * Have a history of inadequate lactation, for multiparous participants who have previously breastfed * Have a significant previous or current history of comorbidities capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking mirikizumab, or of interfering with the interpretation of data * Have any condition that fulfills any contraindication stated in the label. All warnings and precautions stated in the label need to be considered * Have a history of breast augmentation procedures judged to have a clinical impact on breast milk expression such as breast reduction surgery and some breast implants, or current evidence of acute or chronic conditions affecting breasts and potentially interfering with breast milk collection * Have received any live vaccine (that is, live attenuated) within less than 4 weeks or inactivated vaccine within less than 2 weeks before enrollment or intend to receive a live vaccine during the study or an inactivated vaccine 2 weeks postdose, the mother participant must be given the vaccine at an injection site remote from mirikizumab administration

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Conditions

The condition(s) this trial relates to.

Breast Feeding inflammatory bowel disease lactation disease

As listed by the trial registrant

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

Inflammatory bowel disease Lactation

How to take part

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

  1. The places running it

    20 sites in 7 countries. 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

  • Aarhus Universitetshospital, Aarhus Sygehus

    NOT_YET_RECRUITING

    Aarhus N, 82000, Denmark

  • Chaim Sheba Medical Center

    NOT_YET_RECRUITING

    Ramat Gan, 52621, Israel

  • DC-MED Micha Kowalski S.K. - ul. Kilinskiego 6

    NOT_YET_RECRUITING

    Radom, 26-610, Poland

  • Digestive Disease Medicine of Central New York

    NOT_YET_RECRUITING

    Utica, New York, 13502, United States

  • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

    NOT_YET_RECRUITING

    Lazio, 00136, Italy

  • GI Research

    NOT_YET_RECRUITING

    Columbia, V6G 2Z6, Canada

  • Interdisziplinäres Crohn Colitis Centrum Rhein-Main

    NOT_YET_RECRUITING

    Frankfurt am Main, 60594, Germany

  • Johns Hopkins Bayview Medical Center

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21224-2735, United States

  • Klinikum Ernst von Bergmann

    NOT_YET_RECRUITING

    Potsdam, D-14467, Germany

  • Northwest Gastroenterologist

    NOT_YET_RECRUITING

    Glenview, Illinois, 60026-8000, United States

  • Ospedale San Raffaele S.r.l. - PPDS

    NOT_YET_RECRUITING

    Lombardia, 20132, Italy

  • Ospedale Sandro Pertini

    NOT_YET_RECRUITING

    Roma, 00157, Italy

  • Ospedale di Rho - UOC Gastroenterologia

    NOT_YET_RECRUITING

    Rho, 20017, Italy

  • Rabin Medical Center - PPDS

    NOT_YET_RECRUITING

    HaMerkaz, Israel

  • Shaare Zedek Medical Center

    RECRUITING

    Jerusalem, 9013102, Israel

  • Slagelse Hospital

    NOT_YET_RECRUITING

    Slagelse, 4200, Denmark

  • Tel Aviv Sourasky Medical Center Ichilov - PPDS

    RECRUITING

    Tel Aviv, 6423906, Israel

  • University Hospitals Cleveland Medical Center

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44106, United States

  • University of Iowa

    NOT_YET_RECRUITING

    Iowa City, Iowa, 52242, United States

  • WIP Warsaw IBD Point Profesor Kierkus

    NOT_YET_RECRUITING

    Warsaw, 04-501, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.