A Study of Tirzepatide (LY3298176) in Healthy Lactating Females

Lilly

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Tirzepatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT05978713

I8F-MC-GPIN (Other Identifier)

18614

Details and patient eligibility

About

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 given as a single injection under the skin in healthy lactating females. For each participant, the total duration of the study was approximately 8 weeks, including screening.

Enrollment

11 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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