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Tirzepatide in MetALD
Plain-language guide to NCT07046819: phase 2 randomized trial of Tirzepatide, 120 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT07046819
- Phase
- phase 2
- Status
- recruiting participants
- Start
- 2026-06-11
- Completion (planned or actual)
- 2027-07-30
- Participants
- 120 (estimated)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Metabolic Alcohol-associated Liver Disease; Alcohol Use Disorder
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 2) is built around Tirzepatide.
MetALD is a term for the heart, liver, obesity, and other issues that can accompany AUD.
It had two arms (groups): Saline (placebo comparator) and Tirzepatide (active comparator).
The registry classes the interventions as drug and other.
More on the Plan
Il-6, FGF21, epigenetic and genetic markers, proteomics, metabolomics) * Effects on depression and anxiety measures * Effects on epigenetic age acceleration * Changes in brain metabolites as measured by MRI spectroscopy * Changes in resting state functional connectivity.
Who Took Part
120 planned participants were the target.
It was open to people of any sex aged from 21 years up to 100 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age 21 or older. Ability to provide written informed consent. Males: Agree to abstain or use accepted form of contraception, such as condoms. Diagnosis of AUD as confirmed by MINI. Liver steatosis as determined by Fibroscan (CAP score \>240) at screening.
The full record lists 15 inclusion and 25 exclusion criteria; among the exclusions: history of a serious hypersensitivity reaction to glp-1ra/gipra; current/past use of glp-1ra/gipra within the last 3 months; subjects with platelets count of less than 110,000/ mm\^3.
How the Study Was Run
It was run as a randomized, single-group and double-blind study.
The participants were allocated by chance, so the Tirzepatide group and the comparison group should start out alike.
As a double-blind Tirzepatide study, the assignments were hidden from both participants and investigators until the end.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
Those kept unaware of assignments: participant and investigator.
It started in 2026-06-11 with completion listed for 2027-07-30.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 2, randomized trial of Tirzepatide in 120 people.
It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.
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.