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Breastfeeding moms needed for drug safety study

NCT ID NCT07612267

Not yet recruiting Knowledge-focused Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

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

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.

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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

Contacts and locations

Locations

  • Aarhus Universitetshospital, Aarhus Sygehus

    Aarhus N, 82000, Denmark

  • Chaim Sheba Medical Center

    Ramat Gan, 52621, Israel

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

    Radom, 26-610, Poland

  • Digestive Disease Medicine of Central New York

    Utica, New York, 13502, United States

  • Fondazione Policlinico Universitario A Gemelli - Rome - PPDS

    Lazio, 00136, Italy

  • GI Research

    Columbia, V6G 2Z6, Canada

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Interdisziplinäres Crohn Colitis Centrum Rhein-Main

    Frankfurt am Main, 60594, Germany

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224-2735, United States

  • Klinikum Ernst von Bergmann

    Potsdam, D-14467, Germany

  • Northwest Gastroenterologist

    Glenview, Illinois, 60026-8000, United States

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

    Lombardia, 20132, Italy

  • Ospedale Sandro Pertini

    Roma, 00157, Italy

  • Ospedale di Rho - UOC Gastroenterologia

    Rho, 20017, Italy

  • Rabin Medical Center - PPDS

    HaMerkaz, Israel

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Shaare Zedek Medical Center

    Jerusalem, 9013102, Israel

  • Slagelse Hospital

    Slagelse, 4200, Denmark

  • Tel Aviv Sourasky Medical Center Ichilov - PPDS

    Tel Aviv, 6423906, Israel

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 04-501, Poland

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