Trial results for Tirzepatide (NCT05978713), a study investigating the drug in healthy lactating females, were posted on ClinicalTrials.gov on 2025-04-27. The study aimed to determine if tirzepatide enters breastmilk and its elimination kinetics.
Background
The study, titled "A Study of Tirzepatide (LY3298176) in Healthy Lactating Females," focused on understanding the pharmacokinetics of tirzepatide in breastmilk. Specifically, it sought to determine if the study drug gets into breastmilk and how long it takes the body to eliminate it from breastmilk.
Trial design
The study (NCT05978713) was a Phase 1 trial with an enrollment of 11 participants. It involved healthy lactating females and investigated the intervention of tirzepatide. The study administered the drug as a single injection under the skin, with each participant's total study duration being approximately 8 weeks, including screening.
Key results
The trial results posted on ClinicalTrials.gov included an outcome measurement for the "Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide in Breastmilk From Zero to Infinity (AUC [0-∞])" for the 5 mg Tirzepatide group. However, specific quantitative values for the geometric mean and geometric coefficient of variation for this outcome were listed as NA (Not Applicable/Available) in the posted data, with units of nanogram*hours per milliliter (ng*h/mL).
What this means
This Phase 1 pharmacokinetic study in healthy lactating females is crucial for understanding the potential for tirzepatide to be transferred via breastmilk. While the trial results have been posted, the specific quantitative pharmacokinetic data, such as the area under the concentration-time curve in breastmilk, are not detailed in the available public record. This type of data is essential for assessing drug safety and potential exposure in infants of mothers treated with tirzepatide.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05978713, titled "A Study of Tirzepatide (LY3298176) in Healthy Lactating Females," were posted on 2025-04-27 on clinicaltrials.gov.