A Study of Tirzepatide (LY3298176) in Healthy Lactating Females

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Tirzepatide

• Registration Number: NCT05978713
• Lead Sponsor: Eli Lilly and Company

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-31
• Study First Submitted: 2023-07-31
• Study First Submitted QC: 2023-07-31
• Study First Posted: 2023-08-07
• Primary Completion: 2024-03-12
• Study Completion: 2024-03-12
• Results First Submitted: 2025-03-06
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-09
• Last Update Submitted: 2025-04-09
• Results First Posted: 2025-04-27
• Last Update Posted: 2025-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
5 mg Tirzepatide	Tirzepatide	Participants received a single dose of 5 mg tirzepatide injection administered subcutaneously (SC).

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide in Breastmilk From Zero to Infinity (AUC [0-∞])	Predose, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 168, 336, 504, 672 hours post-dose	PK: AUC (0-∞) of Tirzepatide excreted in Breastmilk

Trial Locations

Locations (1)

Las Vegas Clinical Research Unit - PPD; 🇺🇸 Las Vegas, Nevada, United States