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NCT05978713

A Study of Tirzepatide (LY3298176) in Healthy Lactating Females

Completed Phase 1 Results posted Last updated 27 April 2025
What this trial tests

Phase 1 trial testing Tirzepatide in Healthy in 11 participants. Completed in 12 March 2024.

Timeline
31 July 2023
Primary endpoint
12 March 2024
12 March 2024

Quick facts

Lead sponsorEli Lilly and Company
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposebasic science
Enrollment11
Start date31 July 2023
Primary completion12 March 2024
Estimated completion12 March 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Eli Lilly and Company — full company profile →

Who can join

18 and older, female only, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide in Breastmilk From Zero to Infinity (AUC [0-∞]) Primary · Predose, 3, 6, 9, 12, 16, 24, 36, 48, 72, 96, 120, 168, 336, 504, 672 hours post-dose

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

GroupValue95% CI
5 mg TirzepatideNA± NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Baseline to the end of follow-up (up to Day 29). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

5 mg Tirzepatide
Serious: 0/11 (0%)
Deaths: 0/11
Other adverse events (20 terms — click to expand)

ReactionSystem5 mg Tirzepatide
Decreased appetiteMetabolism and nutrition disorders
NauseaGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
HeadacheNervous system disorders
VomitingGastrointestinal disorders
FatigueGeneral disorders
Abdominal distensionGastrointestinal disorders
Abdominal discomfortGastrointestinal disorders
MyalgiaMusculoskeletal and connective tissue disorders
Abdominal painGastrointestinal disorders
Dry mouthGastrointestinal disorders
DyspepsiaGastrointestinal disorders
FlatulenceGastrointestinal disorders
Seasonal allergyImmune system disorders
Back painMusculoskeletal and connective tissue disorders
Musculoskeletal chest painMusculoskeletal and connective tissue disorders
DizzinessNervous system disorders
LethargyNervous system disorders
Abnormal dreamsPsychiatric disorders
CoughRespiratory, thoracic and mediastinal disorders

Data from ClinicalTrials.gov NCT05978713 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Tirzepatide

Trials testing the same drug.

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Eli Lilly and Company trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05978713.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing