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A Study of Tirzepatide in Participants With Impaired Liver Function
Plain-language guide to NCT03940742: phase 1 non-randomized trial of Tirzepatide, 32 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03940742
- Phase
- phase 1
- Status
- completed
- Start
- 2019-07-22
- Completion (planned or actual)
- 2020-09-22
- Participants
- 32 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), basic_science
- Conditions studied
- Hepatic Insufficiency
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Tirzepatide.
The purpose of this study is to assess how fast tirzepatide gets into the blood stream and how long it takes the body to remove it in participants with impaired liver function compared to healthy participants.
The study will last about two months and will include five visits to the study center.
It had four arms (groups): Normal Hepatic Function (active comparator), Mild Hepatic Impairment (experimental), Moderate Hepatic Impairment (experimental) and Severe Hepatic Impairment (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 32 actual participants took part.
It was open to people of any sex aged from 18 years up to 85 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Women of childbearing potential are excluded from the study. Are between the body mass index (BMI) of 19.0 and 40.0 kilograms per meter squared (kg/m²), inclusive, at screening. Males or females with chronic mild, moderate and severe liver impairment, assessed by Child-Pugh scoring.
How the Study Was Run
Design: non-randomized, parallel-group and open-label.
The Tirzepatide group and the comparison group ran side by side rather than switching.
Being open-label, the Tirzepatide study did not mask who received what.
It started in 2019-07-22 with completion listed for 2020-09-22.
It ran at 3 sites in United States (3).
Its stated primary purpose is basic science.
What Was Measured
Researchers chose this as the main measure: PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide.
What This Means in Plain Language
Put simply, this is a phase 1, non-randomized trial of Tirzepatide in 32 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.