A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)

What Was Tested

The trial (phase 2) is built around Tirzepatide.

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 190 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants must have a body mass index (BMI) ≥27 kilograms per square meter (kg/m²) and ≤50 kg/m² with stable body weight for at least 3 months. Participants with or without type 2 diabetes mellitus (T2DM). Participants must be willing to undergo baseline and endpoint liver biopsies. Participants must have histologic diagnosis of NASH with stage 2 or 3 fibrosis by liver biopsy. Participants must not have evidence of cirrhosis or other forms of liver disease.

The full record lists 16 inclusion and 0 exclusion criteria.

How the Study Was Run

The set-up was randomized, parallel-group and double-blind.

Random assignment meant chance, not the researchers, decided who got Tirzepatide and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Tirzepatide.

Those kept unaware of assignments: participant and investigator.

It started in 2019-11-19 with completion listed for 2023-12-11.

It ran at 112 sites in United States (47), Japan (16), United Kingdom (13), France (7), Spain (7) and Israel (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants With Absence of Nonalcoholic Steatohepatitis (NASH) With no Worsening of Fibrosis on Liver Histology (time frame: Week 52).

It also tracked 5 secondary outcomes, for example Mean Absolute Change From Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) and Mean Change From Baseline in Body Weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Tirzepatide in 190 people.

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.