LactationPhase 4NCT07612267
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
A Phase 4 study testing Mirikizumab in people with Lactation and Inflammatory Bowel Disease, run by Eli Lilly and Company at 20 sites in 7 countries.
Trial summary
The main purpose of this study is to assess the amount of mirikizumab in breast milk in women who are breastfeeding who are receiving stable maintenance doses of mirikizumab for an approved indication. Participation in this study could last up to 94 days, including screening and follow-up period. Read more about this study
- Who is it for?
- Ages 3 weeks and older, women only
- Conditions the study is for
- Lactation, Inflammatory Bowel Disease
- What is being tested?
- Mirikizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 20 sitesin 7 countries
- Study dates
- 5 Aug 2026to Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 weeks and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
20 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
20 sites in 7 countries
United States5 sites, 5 recruiting
- Not yet recruiting
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224-2735
Muniz Pedrogo David
- Not yet recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Angelina Gangestad
- Not yet recruiting
Northwest Gastroenterologist
Glenview, Illinois, 60026-8000
Nina Merel
- Not yet recruiting
University of Iowa
Iowa City, Iowa, 52242
Steven Polyak
- Not yet recruiting
Digestive Disease Medicine of Central New York
Utica, New York, 13502
Harvey Allen
Israel4 sites, 4 recruiting
- Not yet recruiting
Rabin Medical Center - PPDS
HaMerkaz
Irit Avni-Biron
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 9013102
Ariella Shitrit
- Not yet recruiting
Chaim Sheba Medical Center
Ramat Gan, 52621
Bella Ungar
- Recruiting
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv, 6423906
Nathaniel Cohen
Italy4 sites, 4 recruiting
- Not yet recruiting
Fondazione Policlinico Universitario A Gemelli - Rome - PPDS
Lazio, 00136
Antonio Gasbarrini
- Not yet recruiting
Ospedale San Raffaele S.r.l. - PPDS
Lombardia, 20132
Silvio Danese
- Not yet recruiting
Ospedale di Rho - UOC Gastroenterologia
Rho, 20017
Simone Saibeni
- Not yet recruiting
Ospedale Sandro Pertini
Roma, 00157
Roberta Pica
Denmark2 sites, 2 recruiting
- Not yet recruiting
Aarhus Universitetshospital, Aarhus Sygehus
Aarhus N, 82000
Mette Juelsgaard
- Not yet recruiting
Slagelse Hospital
Slagelse, 4200
Natalia Pedersen
Germany2 sites, 2 recruiting
- Not yet recruiting
Interdisziplinäres Crohn Colitis Centrum Rhein-Main
Frankfurt am Main, 60594
Juergen Stein
- Not yet recruiting
Klinikum Ernst von Bergmann
Potsdam, D-14467
Daniel Baumgart
Poland2 sites, 2 recruiting
- Not yet recruiting
DC-MED Micha Kowalski S.K. - ul. Kilinskiego 6
Radom, 26-610
Romanowski Janusz
- Not yet recruiting
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 04-501
Jaroslaw Kierkus
Canada1 site, 1 recruiting
- Not yet recruiting
GI Research
Columbia, V6G 2Z6
Yvette Leung
About this study
Official title: A Study to Evaluate Mirikizumab Concentrations in Breast Milk Following Administration of Mirikizumab by Subcutaneous Injection in Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
The main purpose of this study is to assess the amount of mirikizumab in breast milk in women who are breastfeeding who are receiving stable maintenance doses of mirikizumab for an approved indication.
Participation in this study could last up to 94 days, including screening and follow-up period.
- Conditions
- Lactation, Inflammatory Bowel Disease
- Being tested
- Mirikizumab
- Medical subject headings
- Breast Feeding, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirikizumabDrug
Also called LY3074828
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Mirikizumab | Other | Participants will continue to use previously prescribed Mirikizumab administered subcutaneously (SC). Receives: Drug: Mirikizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Mirikizumab in Breast Milk
Measured: Predose up to 28 Days
Secondary outcomes (3)
Pharmacokinetic (PK): Average Concentration During a Dosing Interval in Steady State of Mirikizumab in Breast Milk
Measured: Predose up to 28 Days
Pharmacokinetic (PK): Area Under the Concentration Versus Time Curve Over a Dosing Interval [AUC(0-tau)] of Mirikizumab in Breast Milk
Measured: Predose up to 28 Days
Breastfed Infant Safety as Assessed through Measurement of Infant Weight
Measured: Predose up to 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2026
- Study start5 Aug 2026
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LactationStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07612267
- Sponsor's protocol ID
- 18780
- Other IDs
- I6T-MC-AMCA, 2025-522362-78-00, 2025
- Status last verified
- Nov 2026
- First submitted
- 21 May 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Mirikizumab Concentrations in Breast Milk Following Administration of Mirikizumab by Subcutaneous Injection in Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
- ClinicalTrials.gov ID
- NCT07612267
- Acronym / sponsor ID
- 18780
- Conditions
- Lactation, Inflammatory Bowel Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 28 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of this study is to assess the amount of mirikizumab in breast milk in women who are breastfeeding who are receiving stable maintenance doses of mirikizumab for an approved indication.
Participation in this study could last up to 94 days, including screening and follow-up period.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mirikizumab | Other | Drug: MirikizumabParticipants will continue to use previously prescribed Mirikizumab administered subcutaneously (SC). |
Who may qualify
- Ages
- 3 weeks and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirikizumabAlso: LY3074828Administered SC | Drug | Mirikizumab |
Primary outcome
Concentration of Mirikizumab in Breast Milk
Time frame: Predose up to 28 Days
3 secondary outcomes
Pharmacokinetic (PK): Average Concentration During a Dosing Interval in Steady State of Mirikizumab in Breast Milk
Time frame: Predose up to 28 Days
Pharmacokinetic (PK): Area Under the Concentration Versus Time Curve Over a Dosing Interval [AUC(0-tau)] of Mirikizumab in Breast Milk
Time frame: Predose up to 28 Days
Breastfed Infant Safety as Assessed through Measurement of Infant Weight
Time frame: Predose up to 28 Days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Related trials for Lactation
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Enrolling by invitation
Development and Implementation of a Breastfeeding Program for Post-Cesarean Section Women Based on the 5A Nursing Model
Breastfeeding Rates
RecruitingPhase 4
A Remotely Conducted Study to Assess Concentration of TREMFYA in Breast Milk of Lactating Women Who Are Receiving TREMFYA Therapeutically
Psoriasis, Colitis, Ulcerative
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The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
20 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mirikizumab in people with Lactation and Inflammatory Bowel Disease, run by Eli Lilly and Company at 20 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United States, Israel, Italy, Denmark, Germany and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration of Mirikizumab in Breast Milk (time frame: Predose up to 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.