Pemvidutide

Overview

Pemvidutide is a dual GLP-1 and glucagon receptor agonist investigated in metabolic dysfunction-associated steatohepatitis and related metabolic outcomes. Liver histology, noninvasive markers, weight, and cardiovascular risk factors are distinct endpoints.

Evidence quality

WPF’s atlas includes reports and abstracts from the phase 2b IMPACT study and a meta-analysis of randomized trials. Conference abstracts and top-line reports can flag emerging results, but require comparison with complete methods and peer-reviewed outcome data before firm conclusions.

Safety concerns

A change in a surrogate marker or exploratory analysis does not by itself establish clinical benefit, durability, or an approved indication.

Citations as of this version

• 334-OR: Pemvidutide (ALT-801) , a Balanced (1:1) GLP-1/Glucagon Dual Receptor Agonist, Induces Rapid and Marked Weight Loss without the Need for Dose Titration in People with Overweight/Obesity
• Pemvidutide (ALT-801), a novel GLP-1/glucagon dual receptor agonist, achieves rapid and potent reductions in body weight and liver fat: results of a placebo-controlled, double-blind, first-in-human (FIH) clinical trial
• Abstract 13440: Effect of Pemvidutide (ALT-801), a Novel GLP-1/Glucagon Dual Receptor Agonist, on Pathogenic Lipid Mediators
• LBP-036 Pemvidutide treatment led to fibrosis regression after 24 weeks in patients with metabolic dysfunction-associated steatohepatitis: quantitative digital pathology analysis from the IMPACT phase 2b, multicenter, randomized, placebo-controlled trial
• TOP-176 Concurrent responses in multiple non-invasive tests for hepatic inflammation and fibrosis following pemvidutide treatment: 24-week responder analyses of the phase 2b IMPACT trial in metabolic dysfunction-associated steatohepatitis
• 228-OR: Effect of Pemvidutide, a GLP-1/Glucagon Dual Receptor Agonist, on Cardioinflammatory Lipids
• FRI-201 Effect of pemvidutide on cardiovascular risk factors in patients with metabolic dysfunction-associated steatohepatitis: 48-week results from the phase 2b, IMPACT trial
• OS-016 Week 48 top-line results from the phase 2b, multicenter, randomized, placebo-controlled IMPACT trial of pemvidutide in metabolic dysfunction-associated steatohepatitis
• 748-P: Noninvasive Tests of Central Adiposity Correlate with Reductions in MRI-Measured Visceral Adipose Tissue Mass in Subjects with Overweight or Obesity Treated with Pemvidutide
• 228-OR: Effects of Pemvidutide, a GLP-1/Glucagon Dual Receptor Agonist, on Cardioinflammatory Lipids in Subjects with Obesity or Overweight
• 778-P: Pemvidutide, a Balanced GLP-1/Glucagon Dual Receptor Agonist, Enhances Reverse Cholesterol Transport in a Golden Syrian Hamster Model
• SAT-453 MASH resolution index, a novel, highly sensitive non-invasive measure of histologic improvement, predicts high rates of MASH resolution with pemvidutide treatment of metabolic dysfunction-associated steatohepatitis (MASH)
• 749-P: Integrated Analysis Supports Cardiovascular Safety and Risk Reduction with Pemvidutide Treatment
• Efficacy and Safety of Pemvidutide in Patients with Metabolic Dysfunction-Associated Steatohepatitis: A Systematic Review and Dose-Specific Meta-Analysis of Randomized Controlled Trials
• WED-219 Pemvidutide, a glucagon-like peptide 1/glucagon dual receptor agonist, improves metabolic dysfunction-associated steatohepatitis activity and fibrosis in a clinical quantitative systems pharmacology model
• 262-OR: Pemvidutide, a GLP-1/Glucagon Dual Receptor Agonist, in Subjects with Overweight or Obesity—A 48-Week, Placebo-Controlled, Phase 2 (MOMENTUM) Trial
• WED-212 Pemvidutide treatment is associated with improvement in non-invasive tests indicating greater likelihood of histologic response in subjects with metabolic dysfunction-associated steatotic liver disease: a 24-week, randomized, double-blind, placebo-controlled trial
• WED-251 Plasma lipidomic profiling of subjects with overweight or obesity following treatment with the glucagon-like peptide 1/glucagon dual receptor agonist pemvidutide: an investigation of lipid signatures associated with metabolic dysfunction-associated steatohepatitis
• Pemvidutide, a glp-1/glucagon dual receptor agonist, significantly reduces liver fat, fibro-inflammation, and body weight in patients with non-alcoholic fatty liver disease: a 24-week multicenter, randomized, double-blind, placebo-controlled trial
• Efficacy and safety of pemvidutide in metabolic dysfunction-associated steatohepatitis: a GRADE-assessed meta-analysis of randomized controlled trials. (2026)
• Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease: A randomized, controlled clinical trial. (2025)
• Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study. (2025)
• Safety and efficacy of weekly pemvidutide versus placebo for metabolic dysfunction-associated steatohepatitis (IMPACT): 24-week results from a multicentre, randomised, double-blind, phase 2b study. (2025)
• The dual GLP-1-glucagon agonist pemvidutide in MASH: a phase 2b trial. (2025)

Regulatory status as of this version

• United States — FDA: not_approved
• European Union — EMA: not_approved