Phase 3 Study of the Efficacy, Safety, and Clinical Outcomes of Pemvidutide in MASH

What Was Tested

In this phase 3 trial, researchers set out to test Pemvidutide.

Participants will be assigned either to Cohort 1 based on screening histologic (liver biopsy) criteria or to Cohort 2 based on non-invasive test criteria.

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

The registry classes the interventions as drug and other.

Who Took Part

1800 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Body mass index (BMI) ≥ 25.0 kg/m2; if Asian, BMI ≥ 23.0 kg/m2. Type 2 diabetes (T2D) or at least 2 components of metabolic syndrome. Subject agrees to have liver biopsy(ies) as required per protocol.

The full record lists 4 inclusion and 2 exclusion criteria.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Pemvidutide group and the comparison group should start out alike.

The Pemvidutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Pemvidutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2026-07-30 with completion listed for 2028-12.

It ran at 9 sites in United States (9).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Clinical Outcome Event (time frame: Baseline through end of study (approximately Month 60)). Histological Response: MASH resolution (time frame: Baseline through Week 52).

It also tracked 11 secondary outcomes, for example Anthropometric parameters: Relative (%) change from baseline in body weight (kg), Anthropometric parameters: Relative (%) change from baseline in body mass index (BMI; kg/m2), Anthropometric parameters: Relative (%) change from baseline in waist circumference (cm), Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Absolute change from baseline in alanine aminotransferase (ALT; U/L), Noninvasive Tests of MASH Inflammatory and Fibrotic Activity: Absolute change from baseline in enhanced liver fibrosis (ELF) score and HRQoL: Change from baseline in core symptoms of MASH on the NASH-CHECK questionnaire.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Pemvidutide in 1800 people.

With 1800 participants it is a large trial for this field.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Pemvidutide compound page, all human trials.