A Study of Tirzepatide (LY3298176) in Healthy Lactating Females

NCT05978713 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 18614I8F-MC-GPIN
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

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

  PK: AUC (0-∞) of Tirzepatide excreted in Breastmilk

  Predose, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 168, 336, 504, 672 hours post-dose

Study Arms (1)

5 mg Tirzepatide

EXPERIMENTAL

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

Drug: Tirzepatide

Interventions

Tirzepatide DRUG

Administered SC

Also known as: LY3298176

5 mg Tirzepatide

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Las Vegas Clinical Research Unit - PPD

Las Vegas, Nevada, 89113-2228, United States

Location

MeSH Terms

Interventions

Tirzepatide

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 7, 2023
• Study Start: July 31, 2023
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: April 27, 2025
• Results First Posted: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)