A Study of Tirzepatide (LY3298176) in Healthy Lactating Females

NCTNCT05978713Other id18614Other idI8F-MC-GPIN

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 11 participants (actual)
Sponsor: Eli Lilly and Company · Industry
Design: Allocation not applicable · Open label (no masking)
Countries: 1 country
United States
Start: 31 Jul 2023
Primary completion: 12 Mar 2024
Completion: 12 Mar 2024
First posted: 7 Aug 2023
Last update posted: 27 Apr 2025
Conditions: Healthy

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

202320242025

Ph 1
A Study of Tirzepatide (LY3298176) in Healthy Lactating Females
NCT05978713
31 Jul 2023 to 12 Mar 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

TirzepatideDrug

Arms1

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

Primary outcomes1

Outcomes the sponsor listed as primary.

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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

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

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

Group	Value (nanogramhours per milliliter (ngh/mL))	Spread
5 mg Tirzepatide	NA	NA

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
5 mg TirzepatideParticipants received a single dose of 5 mg tirzepatide injection administered SC.	0 / 11	0 / 11	11 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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