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Completed

NCT Number: NCT05978713

A Study of Tirzepatide (LY3298176) in Healthy Lactating Females

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Las Vegas Clinical Research Unit - PPD

Las Vegas, Nevada, 89113-2228, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Primary outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide in Breastmilk From Zero to Infinity (AUC [0-∞])

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Study to Evaluate Tirzepatide Concentrations in Breastmilk Following Administration of Single Dose of Tirzepatide by Subcutaneous Injection in Healthy Lactating Females

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 7, 2023
Registry last updated
Apr 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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