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NCT05978713 Clinical Trial

A Study of Tirzepatide (LY3298176) in Healthy Lactating Females

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05978713
Other study ID # 18614
Secondary ID I8F-MC-GPIN
Status Completed
Phase Phase 1
First received
Last updated
Start date July 31, 2023
Est. completion date March 12, 2024

Study information
Verified date April 2024
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main purpose of this study is to look if the study drug, tirzepatide, gets into the breast milk and if yes, how long it takes the body to get rid of it. The study drug will be given as a single injection under the skin in healthy lactating females. For each participant, the total duration of the study will be approximately 8 weeks, including screening.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date March 12, 2024
Est. primary completion date March 12, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Tirzepatide
Administered SC

Locations
Country Name City State
United States Las Vegas Clinical Research Unit - PPD Las Vegas Nevada

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve in Breast Milk From Zero to Infinity (AUC [0-8]) of Tirzepatide PK: AUC (0-8) of Tirzepatide Predose up to 30 days postdose
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