pemvidutide (ALT-801) / Altimmune - LARVOL DELTA

Muscle Loss in Obesity Therapy as a Therapeutic Target: Trial Design and Endpoints for Regulatory Discussions. (PubMed, J Cachexia Sarcopenia Muscle) - "Discussions highlighted the impact of glucagon-like peptide-1 (GLP-1) receptor agonists or GLP-1/glucose-dependent insulinotropic polypeptide (i.e., GLP-1/GIP) agonists on body composition and muscle health; the challenges of distinguishing 'true' skeletal muscle from fat-free tissue; the impact of treatment discontinuation and weight regain; advances in imaging and quantitative assessment of lean body mass; as well as insights from emerging muscle-preserving therapies (e.g., bimagrumab, pemvidutide and enobosarm)...These also involve significant regulatory considerations for future drug development and approval pathways, for instance related to the very large number of individuals that may be considered for these therapeutic approaches as well as from the potential long (or life-long) duration of therapy considered with these drugs. Together, these discussions highlight the growing importance of integrating body composition and functional assessments in future..."

Journal • Cachexia • Genetic Disorders • Obesity • Sarcopenia

The dual GLP-1-glucagon agonist pemvidutide in MASH: a phase 2b trial. (PubMed, Lancet) - No abstract available

Journal • P2b data • Metabolic Dysfunction-Associated Steatohepatitis

RECLAIM STUDY: A Phase 2 Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight (clinicaltrials.gov) - P2 | N=100 | Active, not recruiting | Sponsor: Altimmune, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2026 ➔ Jun 2026 | Trial primary completion date: Sep 2026 ➔ May 2026

Enrollment closed • Trial completion date • Trial primary completion date • Addiction (Opioid and Alcohol) • Genetic Disorders • Obesity

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. (PubMed, Lancet) - P2 | "Pemvidutide treatment met the primary endpoint of MASH resolution without worsening of fibrosis at 24 weeks but did not meet the other primary endpoint of fibrosis improvement without worsening of MASH at this timepoint. Additional trials of longer duration are planned."

Journal • P2b data • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

DA-1726, An Oxyntomodulin Analogue: A Promising Therapy for Obesity and Related Metabolic Disorders (OBESITY WEEK 2025) - "In conclusion, these findings suggest that DA-1726 offers advantages including superior weight loss, increased EE, and improved lipid metabolism. These results support the potential of DA-1726 as a promising therapeutic option for the treatment of obesity and associated metabolic disorders."

Dyslipidemia • Genetic Disorders • Metabolic Disorders • Obesity

Recent Highlights and Anticipated Milestones: Metabolic Dysfunction-Associated Steatohepatitis (MASH) (GlobeNewswire) - "End-of-Phase 2 Meeting with FDA scheduled for fourth quarter 2025: During the in-person meeting, the Company is seeking alignment with the Agency on its proposed Phase 3 trial design and study endpoints; 48-week data from Phase 2b IMPACT Trial to be reported in fourth quarter 2025: The readout will include longer-term NIT and weight loss data."

FDA event • P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Altimmune Presents AI-Based Analysis of Liver Fibrosis Reduction from IMPACT Phase 2b Trial of Pemvidutide in MASH in Late-breaking Poster at AASLD The Liver Meeting 2025 (GlobeNewswire) - "Data for total fibrosis showed 31% of patients in the pemvidutide 1.8 mg group (n=85), and 12% of patients in the pemvidutide 1.2 mg group (n=41) achieved a ≥ 60% reduction in the area of fibrosis compared to 8% of placebo-treated patients (n=86, p= 0.0003 and p=0.5, respectively); Data for early fibrosis showed 34% of patients in the pemvidutide 1.8 mg group (n=85), and 24% of patients in the pemvidutide 1.2 mg group (n=41) achieved ≥ 60% reduction in the area of fibrosis compared to 9% of placebo-treated patients...Data for advanced fibrosis showed 27% of patients in the pemvidutide 1.8 mg group (n=85), and 5% of patients in the pemvidutide 1.2 mg group (n=41) achieved ≥ 60% reduction in the area of fibrosis..."

Late-breaking abstract • P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Incretin-Based Therapies in MASH: A Meta-Analysis of Hepatic and Metabolic Outcomes (ACG 2025) - "Incretin-based therapies significantly reduced liver fat in MASH patients. Triple agonist retatrutide achieved the greatest reduction (up to 83%), followed by dual GLP-1/glucagon agonists (pemvidutide: 64%, survodutide: 60%) and GLP-1/GIP agonist tirzepatide (47%). GLP-1 monotherapy (semaglutide) also reduced liver fat (39%) and improved liver enzymes."

Retrospective data • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease

Altimmune to Present Phase 2b IMPACT Data on Pemvidutide in MASH in Late-Breaking Oral Podium Presentation and Late-Breaking Poster at AASLD The Liver Meeting 2025 (GlobeNewswire) - "Oral presentation to highlight 24-week efficacy and safety data. Poster to feature results of AI-based analyses of liver fibrosis reduction."

P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease: A randomized, controlled clinical trial. (PubMed, JHEP Rep) - P1 | "The current trial demonstrates that continued treatment with pemvidutide further improves these clinical markers of MASH. The study is registered at ClinicalTrials.gov (NCT05292911)."

Clinical • Journal • Diabetes • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity • Type 2 Diabetes Mellitus

Altimmune Appoints Industry Veteran Christophe Arbet-Engels, M.D., PhD as Chief Medical Officer to Drive Next Phase of Clinical Development of Pemvidutide. (GlobeNewswire) - Dr Arbet-Engels...will lead the ongoing clinical development of pemvidutide including the planned Phase 3 trial in metabolic dysfunction-associated steatohepatitis (MASH).

New P3 trial • Metabolic Dysfunction-Associated Steatohepatitis

Altimmune Announces FDA Fast Track Designation for Pemvidutide in Alcohol Use Disorder (AUD) (GlobeNewswire) - "RECLAIM (NCT06987513), a Phase 2 trial evaluating the safety and efficacy of pemvidutide in AUD, is currently enrolling."

Enrollment status • Fast track • Addiction (Opioid and Alcohol)

Review: Special Issue: Real-world evidence on the use of GLP1 receptor agonists: Emerging concepts in obesity management: focus on glucagon receptor agonist combinations. (PubMed, Drugs Context) - "Agents like mazdutide, pemvidutide, survodutide and retatrutide have demonstrated the ability to trigger significant weight loss in earlier phase trials, often surpassing the amount of weight loss obtained with existing therapies...Key considerations as these drugs move forward in development to eventual approval include cost, access and long-term safety. This article is part of the Real-world evidence on the use of GLP1 receptor agonists Special Issue: https://www.drugsincontext.com/special_issues/real-world-evidence-on-the-use-of-glp1-receptor-agonists."

HEOR • Journal • Real-world evidence • Review • Cardiovascular • Diabetes • Endocrine Disorders • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

New data on corrected T1 (cT1) imaging demonstrates potentially class-leading improvements in pemvidutide-treated patients (GlobeNewswire) - "cT1 is a highly reproducible MRI-based imaging method that measures the magnitude of liver inflammation and fibrosis. Decreases in cT1 relaxation time of 80 milliseconds (ms) or greater have been correlated with improvements in liver inflammation and fibrosis in clinical studies; In an analysis of imaging data from the IMPACT trial, mean decreases from baseline in cT1 relaxation time were 145.0 ms and 147.9 ms in the pemvidutide 1.2 mg and 1.8 mg groups, respectively, compared with a decrease of 27.5 ms in placebo (p < 0.001 for both)....The IMPACT trial is ongoing with data on weight loss, NITs and safety at 48 weeks of treatment expected in the fourth quarter of 2025; End-of-Phase 2 Meeting with FDA targeted for fourth quarter of 2025."

FDA event • P2b data • Metabolic Dysfunction-Associated Steatohepatitis

RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD) (clinicaltrials.gov) - P2 | N=100 | Recruiting | Sponsor: Altimmune, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatology

Altimmune Announces Initiation of RESTORE Phase 2 Trial Evaluating the Efficacy and Safety of Pemvidutide in Alcohol-Associated Liver Disease (ALD) (GlobeNewswire) - "Altimmune, Inc...announced that it has enrolled the first patient in the RESTORE Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol-Associated Liver Disease (ALD)...RESTORE (NCT07009860) is a randomized, placebo-controlled trial enrolling approximately 100 patients across 34 sites, with Dr. Rohit Loomba, Professor of Medicine, Chief of the Division of Gastroenterology and Hepatology, and Director of the MASLD Research Center at the University of California, San Diego, serving as the principal investigator. Patients will be randomized 1:1 to 2.4mg pemvidutide or placebo for 48 weeks. The primary endpoint of the trial is the change from baseline in liver stiffness measurement (LSM) by vibration controlled transient elastography (VCTE) at Week 24."

Enrollment open • Hepatology

Altimmune to Announce Topline 24 Week Results from its IMPACT Phase 2b Trial of Pemvidutide in the Treatment of MASH on Thursday, June 26 (GlobeNewswire) - "Altimmune...will host an investor webcast on Thursday, June 26, 2025 at 8:30 am E.T. to present topline 24 week data from its IMPACT Phase 2b trial evaluating pemvidutide in the treatment of patients with metabolic dysfunction-associated steatohepatitis (MASH)....A final readout is anticipated in the fourth quarter of 2025."

P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Topline Results from the IMPACT Phase 2b Trial of Pemvidutide in the Treatment of MASH (GlobeNewswire) - P2b | N=190 | IMPACT (NCT05989711) | Sponsor: Altimmune, Inc. | "Treatment discontinuation rates were low, with only 9% of participants prematurely discontinuing treatment. In an intent-to-treat (ITT) analysis, in which participants with missing biopsies were considered non-responders, the proportions of participants achieving MASH resolution without worsening of fibrosis at 24 weeks were 59.1% and 52.1% for pemvidutide 1.2 mg and 1.8 mg, respectively versus 19.1% for placebo (p< 0.0001 both doses). The effects on fibrosis improvement without worsening of MASH in an ITT analysis were 31.8% and 34.5% for pemvidutide 1.2 mg and 1.8 mg, respectively compared with 25.9% for placebo (differences not statistically significant)...final readout is anticipated in the fourth quarter of 2025."

P2b data • Metabolic Dysfunction-Associated Steatohepatitis

Pemvidutide, a Balanced GLP-1/Glucagon Dual Receptor Agonist, Enhances Reverse Cholesterol Transport in a Golden Syrian Hamster Model (ADA 2025) - "Pemvidutide treatment increased excretion of cholesterol into feces and upregulated transporters of cellular cholesterol in the liver, consistent with increased RCT. These findings suggest that in addition to other mechanisms, pemvidutide improves serum cholesterol through enhanced cholesterol excretion."

Preclinical • Metabolic Disorders • Obesity

Integrated Analysis Supports Cardiovascular Safety and Risk Reduction with Pemvidutide Treatment (ADA 2025) - "Pemvidutide reduces SBP and DBP without clinically meaningful effects on QTc or HR and no imbalances in cardiac adverse events."

Clinical • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

Noninvasive Tests of Central Adiposity Correlate with Reductions in MRI-Measured Visceral Adipose Tissue Mass in Subjects with Overweight or Obesity Treated with Pemvidutide (ADA 2025) - "BRI and WHtR may be useful for estimating VAT mass changes resulting from pemvidutide treatment."

Clinical • Non-invasive • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Obesity

Effects of Pemvidutide, a GLP-1/Glucagon Dual Receptor Agonist, on Cardioinflammatory Lipids in Subjects with Obesity or Overweight (ADA 2025) - "Pemvidutide elicited significant weight loss and decreases in atherogenic pro-inflammatory lipid species in subjects with obesity or overweight."

Clinical • Diabetes • Metabolic Disorders • Obesity

Altimmune Announces Multiple Presentations at Upcoming American Diabetes Association’s Scientific Sessions (GlobeNewswire) - "Altimmune, Inc....today announced an oral presentation and three poster presentations on pemvidutide at the American Diabetes Association’s (ADA) 85th Scientific Sessions, to be held in Chicago, IL from June 20-23, 2025."

Clinical data • Obesity

IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (clinicaltrials.gov) - P2 | N=190 | Active, not recruiting | Sponsor: Altimmune, Inc. | Trial completion date: Sep 2025 ➔ Dec 2025

Trial completion date • Hepatology • Metabolic Dysfunction-Associated Steatohepatitis

RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD) (clinicaltrials.gov) - P2 | N=100 | Not yet recruiting | Sponsor: Altimmune, Inc.

New P2 trial • Hepatology