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A Study of Tirzepatide (LY3298176) in Healthy Lactating Females

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05978713
Collaborator
(none)
14
Enrollment
1
Location
1
Arm
11.4
Anticipated Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
14 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Study to Evaluate Tirzepatide Concentrations in Breastmilk Following Administration of Single Dose of Tirzepatide by Subcutaneous Injection in Healthy Lactating Females
Anticipated Study Start Date :
Jul 31, 2023
Anticipated Primary Completion Date :
Jul 12, 2024
Anticipated Study Completion Date :
Jul 12, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide

A single dose of tirzepatide administered subcutaneously (SC)

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve in Breast Milk From Zero to Infinity (AUC [0-∞]) of Tirzepatide [Predose up to 30 days postdose]

      PK: AUC (0-∞) of Tirzepatide

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Las Vegas Clinical Research Unit - PPD Las Vegas Nevada United States 89113

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT05978713
    Other Study ID Numbers:
    • 18614
    • I8F-MC-GPIN
    First Posted:
    Aug 7, 2023
    Last Update Posted:
    Aug 7, 2023
    Last Verified:
    Jul 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tirzepatide

    Study Results

    No Results Posted as of Aug 7, 2023