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A Study of Tirzepatide (LY3298176) in Healthy Lactating Females
Plain-language guide to NCT05978713: phase 1 interventional trial of Tirzepatide, 11 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05978713
- Phase
- phase 1
- Status
- completed
- Start
- 2023-07-31
- Completion (planned or actual)
- 2024-03-12
- Participants
- 11 (actual)
- Design
- na, open label (everyone knows who gets what), basic_science
- Conditions studied
- Healthy
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Tirzepatide.
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.
It had 1 arm (groups): one (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 11 actual participants took part.
It was open to women only aged from 18 years with no upper age limit.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: 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.
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: 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.
How the Study Was Run
The set-up was single-group and open-label.
Being open-label, the Tirzepatide study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2023-07-31 with completion listed for 2024-03-12.
It ran at 1 site in United States.
Its stated primary purpose is basic science.
What This Means in Plain Language
Put simply, this is a phase 1 trial of Tirzepatide in 11 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Tirzepatide compound page, all human trials.
Our Notes on the Compound
Tirzepatide: A prescription peptide medicine that acts on both the GIP and GLP-1 receptors; Mounjaro and Zepbound contain the same active ingredient.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.