A Study of Tirzepatide (LY3298176) in Healthy Lactating Females

Part of paid clinical trials in Las Vegas, Nevada.

Sponsor
Eli Lilly and Company
Study ID
NCT05978713
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Jul 31, 2023
Status verified
Apr 2025
Primary completion
Mar 12, 2024
Completion
Mar 12, 2024

Study Design

Enrollment
11 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 5 mg Tirzepatide
    Participants received a single dose of 5 mg tirzepatide injection administered subcutaneously (SC).

Primary Outcome Measure

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 ]

Locations (1)

FacilityCityStateZIPSite coordinators
Las Vegas Clinical Research Unit - PPDLas VegasNevada89113-2228-

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Las Vegas Clinical Research Unit - PPD· Las Vegas, NV

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