A Study of Tirzepatide (LY3298176) in Healthy Lactating Females

NCT05978713 · Completed

Last updated 2026-05-28

This study is testing how tirzepatide, a medication, is passed into breast milk in healthy women who are breastfeeding.

Status Completed The study has finished.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design open-label (no blinding) basic-science study

Participants 11 people

Who can join Ages 18+ · female only Healthy volunteers accepted.

Timeline Started 2023-07 · est. completion 2024-03

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT05978713 ↗

Description as written by the study sponsor.

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.

Treatments tested

Tirzepatide also known as LY3298176 Drug

Administered SC

Main thing measured	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide in Breastmilk From Zero to Infinity (AUC [0-∞])
Sponsor	Eli Lilly and Company
Conditions studied	Healthy
GLP-1 drugs	tirzepatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT05978713 ↗