A Study of Tirzepatide (LY3298176) in Healthy Lactating Females
Launched by ELI LILLY AND COMPANY · Jul 31, 2023
Trial Information
Current as of May 27, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • 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 Criteria:
- • 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
About Eli Lilly And Company
Eli Lilly and Company is a global healthcare leader dedicated to creating innovative medicines that improve patient outcomes across a range of therapeutic areas, including diabetes, oncology, immunology, and neurodegenerative diseases. With a rich history of scientific research and a commitment to advancing healthcare, Lilly invests significantly in clinical trials to develop new treatments and enhance existing therapies. The company prioritizes patient safety and ethical standards in its clinical research, fostering collaboration with healthcare professionals and stakeholders to ensure the delivery of high-quality, evidence-based solutions that address unmet medical needs worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Patients applied
Trial Officials
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Study Director
Eli Lilly and Company
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported