Status:
COMPLETED
A Study of Tirzepatide (LY3298176) in Healthy Lactating Females
Lead Sponsor:
Eli Lilly and Company
Conditions:
Healthy
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
Brief Summary
The main purpose of this study was to look if the study drug, tirzepatide, gets into the breastmilk and, if yes, how long it takes the body to get rid of it from the breastmilk. The study drug was giv...
Eligibility Criteria
Inclusion
- Participants who are overtly healthy females as determined by medical evaluation
- Female participants who delivered normal-term infant (at least 37 weeks gestation) and are at least 6 weeks postpartum at the time of screening
- Body mass index (BMI) between 18.5 and 40.0 kilograms per meter squared (kg/m²), inclusive
- Female participants who has well-established lactation and is breastfeeding her infant. Note: Breastfeeding must be discontinued prior to the administration of tirzepatide on Day 1 and not resumed for the remaining duration of the study until a follow-up visit (or for total of 29 days after tirzepatide dosing for participants who discontinue early).
Exclusion
- Have a history of inadequate lactation (for multiparous females who have previously breastfed)
- Have confirmed type 1 or type 2 diabetes mellitus
- Regularly use known drugs of abuse or show positive findings on drug screen
Key Trial Info
Start Date :
July 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 12 2024
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05978713
Start Date
July 31 2023
End Date
March 12 2024
Last Update
April 27 2025
Active Locations (1)
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1
Las Vegas Clinical Research Unit - PPD
Las Vegas, Nevada, United States, 89113-2228