---
title: "Pemvidutide | PepTracker Pro"
url: https://peptrackerpro.com/peptides/pemvidutide
description: "A GLP-1/glucagon dual receptor agonist with FDA Breakthrough Therapy Designation for MASH, showing strong weight loss and liver benefits in Phase 2 trials."
lang: en
---

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# Pemvidutide

Medium Evidence

A GLP-1/glucagon dual receptor agonist with FDA Breakthrough Therapy Designation for MASH, showing strong weight loss and liver benefits in Phase 2 trials.

Aliases ALT-801 +1 more

Evidence Medium Evidence

Last Updated 2026-05-28

Reading Time 3 min

## What It Is

Pemvidutide (ALT-801) is a balanced 1:1 GLP-1/glucagon dual receptor agonist developed by Altimmune for obesity and metabolic dysfunction-associated steatohepatitis (MASH). Its balanced glucagon receptor activation distinguishes it from competitors by directly targeting hepatic fat metabolism — addressing both weight loss and liver pathology. Altimmune received FDA Breakthrough Therapy Designation for pemvidutide in MASH, positioning it in a market where no peptide therapy has yet been approved. In December 2025, the 48-week IMPACT topline data showed statistically significant improvements versus placebo in key non-invasive liver tests, with patients receiving the 1.8 mg dose achieving continued weight loss with no evidence of plateauing. The dual mechanism provides both peripheral fat mobilization (via glucagon) and central appetite suppression (via GLP-1), with the liver-focused development program differentiating it from the obesity-focused competition. In the 48-week IMPACT trial, the 1.8 mg dose reduced liver fat by 54.7% (vs 8.2% placebo), with 0–1.2% adverse event discontinuation rates — a safety profile that positions pemvidutide favorably against competitors in the MASH space. Altimmune completed its End-of-Phase 2 FDA meeting in early 2026, aligning on registrational Phase 3 trial design, with program initiation planned for 2026. In May 2026, Altimmune announced positive 48-week results from the IMPACT Phase IIb trial: ELF scores fell by 0.49 (1.2 mg) and 0.58 (1.8 mg) versus placebo, liver stiffness measurements dropped by 3.04 and 3.97 kPa respectively, and body weight decreased by 4.5% (1.2 mg) and 7.5% (1.8 mg) versus 0.2% placebo. The PERFORMA Phase 3 MASH trial is planned for initiation in H2 2026, incorporating biopsy-based endpoints and AIM-MASH AI Assist -- the first FDA-qualified AI pathology tool for use in MASH clinical trials. At EASL Congress 2026 (May 27-30, Barcelona), Altimmune presented late-breaking data from the IMPACT Phase 2b trial that was selected as Best of EASL 2026. The presentation showed 68.6% of patients on pemvidutide 1.2 mg and 54.5% on 1.8 mg achieved ≥1 stage qFibrosis regression (quantitative digital pathology) at 24 weeks compared with 29.6% on placebo (p<0.001 and p=0.002, respectively). Concurrent improvements were demonstrated across multiple non-invasive markers including ELF, liver stiffness, FibroScan-AST (FAST), FIB-4, and APRI scores, reinforcing pemvidutide's antifibrotic activity profile.

Also known as: ALT-801, Altimmune GLP-1/Glucagon

## Regulatory Status

Investigational — FDA Breakthrough Therapy Designation

Granted FDA Breakthrough Therapy Designation for MASH in January 2026. Phase 3 program initiation planned for 2026. End-of-Phase 2 meeting with FDA completed successfully.

Effective: January 2026

View FDA Source (https://ir.altimmune.com/news-releases/news-release-details/altimmune-receives-fda-breakthrough-therapy-designation)

## Why Researchers Study It

Pemvidutide's dual GLP-1/glucagon mechanism addresses both weight management and liver disease simultaneously, making it one of few candidates targeting the obesity-MASH overlap. Its favorable lean mass preservation ratio and FDA Breakthrough Therapy Designation for MASH position it as a differentiated next-generation metabolic peptide.

## Proposed Mechanisms

- GLP-1 receptor agonism reduces appetite and food intake centrally
- Glucagon receptor activation increases hepatic fat oxidation and energy expenditure
- Dual agonism produces synergistic weight loss beyond GLP-1 alone
- Liver-targeted glucagon signaling directly reduces hepatic steatosis
- Favorable fat-to-lean mass loss ratio suggests muscle preservation

## Evidence Snapshot

Medium Evidence

Low

Medium

High

| Study Type | Model | Outcome | Link |
| --- | --- | --- | --- |
| Phase 2 (MOMENTUM) | 48-week, obesity without T2D | 15.6% weight loss at 2.4 mg; 78.1% of loss was fat; near-linear trajectory at 48 weeks | Source: https://ir.altimmune.com/news-releases/news-release-details/altimmune-announces-positive-topline-results-momentum-48-week |
| Phase 2b (IMPACT) | 48-week, patients with MASH | Significant improvements in ELF and liver stiffness vs placebo; 7.5% weight loss at 1.8 mg | Source: https://ir.altimmune.com/news-releases/news-release-details/altimmune-announces-pemvidutide-achieved-key-measures-success-48 |
| Phase 2b (IMPACT, 48-week) | MASH patients — Enhanced Liver Fibrosis and Liver Stiffness Measurement | Statistically significant improvements in ELF and LSM vs placebo at 48 weeks; continued antifibrotic activity; MASH resolution met at 24 weeks | Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02114-2/abstract |
| Phase 2b (IMPACT, 48-week granular) | MASH patients — hepatic fat fraction by MRI-PDFF | Liver fat decreased 45.2% (1.2 mg) and 54.7% (1.8 mg) vs 8.2% placebo; ELF −0.49/−0.58 vs +0.16; LSM −3.04/−3.97 vs −0.03; AE discontinuation 0% (1.2 mg) and 1.2% (1.8 mg) vs 3.5% placebo | Source: https://ir.altimmune.com/news-releases/news-release-details/altimmune-announces-pemvidutide-achieved-key-measures-success-48 |
| Human (Phase IIb, IMPACT 48-week) | Pemvidutide 1.2mg and 1.8mg in MASH patients, 48 weeks | Significant improvements in ELF, liver stiffness, and weight loss; PERFORMA Phase 3 planned H2 2026 with AI-assisted pathology | Source: https://ir.altimmune.com/news-releases/news-release-details/altimmune-announces-pemvidutide-achieved-key-measures-success-48 |
| Human (Phase 2b, IMPACT — EASL 2026 Best of Congress) | MASH patients — qFibrosis quantitative digital pathology at 24 weeks | 68.6% (1.2 mg) and 54.5% (1.8 mg) achieved ≥1 stage qFibrosis regression vs 29.6% placebo (p<0.001 and p=0.002); concurrent improvements across ELF, liver stiffness, FAST, FIB-4, and APRI | Source: https://www.biospace.com/press-releases/new-impact-phase-2b-data-highlight-concurrent-improvements-across-multiple-non-invasive-markers-and-qfibrosis-measured-fibrosis-regression-with-pemvidutide-in-mash-at-easl-2026 |

## Commonly Discussed Benefits

Weight Management: https://peptrackerpro.com/benefits/weight-management
Fat Loss: https://peptrackerpro.com/benefits/fat-loss
Liver Health: https://peptrackerpro.com/benefits/liver-health
Metabolism: https://peptrackerpro.com/benefits/metabolism

Researching Pemvidutide? Track it, set reminders, and keep notes in the free app.

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## Safety & Cautions

- Phase 3 trials have not yet begun
- Glucagon component may raise theoretical concerns about blood glucose in diabetic patients
- Long-term safety data beyond 48 weeks is limited
- Not FDA-approved for any indication yet
- Breakthrough Therapy Designation does not guarantee approval

## Comparisons

See how Pemvidutide compares to related peptides:

Pemvidutide vs Efinopegdutide: https://peptrackerpro.com/compare/pemvidutide-vs-efinopegdutide

Pemvidutide vs Efocipegtrutide: https://peptrackerpro.com/compare/pemvidutide-vs-efocipegtrutide

Pemvidutide vs Efpeglenatide: https://peptrackerpro.com/compare/pemvidutide-vs-efpeglenatide

Pemvidutide vs Efruxifermin: https://peptrackerpro.com/compare/pemvidutide-vs-efruxifermin

Pemvidutide vs Pegozafermin: https://peptrackerpro.com/compare/pemvidutide-vs-pegozafermin

Pemvidutide vs Retatrutide: https://peptrackerpro.com/compare/pemvidutide-vs-retatrutide

Pemvidutide vs Semaglutide: https://peptrackerpro.com/compare/pemvidutide-vs-semaglutide

Pemvidutide vs Survodutide: https://peptrackerpro.com/compare/pemvidutide-vs-survodutide

Pemvidutide vs Tirzepatide: https://peptrackerpro.com/compare/pemvidutide-vs-tirzepatide

## Calculator Tools

Use our research tools to explore dosing and reconstitution data:

Reconstitution Calculator: https://peptrackerpro.com/calculators

## Citations

1. [1] Altimmune — Positive Topline Results from MOMENTUM 48-Week Phase 2 Obesity Trial. 2026 PubMed (https://ir.altimmune.com/news-releases/news-release-details/altimmune-announces-positive-topline-results-momentum-48-week)
2. [2] Altimmune — FDA Breakthrough Therapy Designation for Pemvidutide in MASH. January 2026 PubMed (https://ir.altimmune.com/news-releases/news-release-details/altimmune-receives-fda-breakthrough-therapy-designation)
3. [3] Safety and efficacy of pemvidutide vs placebo for MASH (IMPACT): 24-week results — The Lancet 2026 PubMed (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)02114-2/abstract)
4. [4] Altimmune -- Pemvidutide IMPACT Phase IIb 48-Week Results. May 2026 PubMed (https://ir.altimmune.com/news-releases/news-release-details/altimmune-announces-pemvidutide-achieved-key-measures-success-48)
5. [5] Altimmune — IMPACT Phase 2b qFibrosis Regression and Non-Invasive Markers at EASL Congress 2026 (Best of EASL) PubMed (https://www.biospace.com/press-releases/new-impact-phase-2b-data-highlight-concurrent-improvements-across-multiple-non-invasive-markers-and-qfibrosis-measured-fibrosis-regression-with-pemvidutide-in-mash-at-easl-2026)

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## Related Peptides

### Efinopegdutide

Medium Evidence

Efinopegdutide (MK-6024, formerly HM12525A and JNJ-64565111) is an investigational once-weekly subcutaneous dual agonist of the GLP-1 and glucagon receptors being developed by Merck for metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH) and steatotic liver disease. It is a synthetic oxyntomodulin-based peptide - a modified GLP-1/glucagon dual-agonist sequence conjugated to a human IgG4 Fc fragment through a 10 kDa polyethylene glycol linker using Hanmi Pharmaceutical's LAPSCovery half-life-extension platform, which stretches dosing to once weekly. The design pairs the GLP-1 arm (appetite suppression, glycemic control, weight loss) with a glucagon arm that raises energy expenditure and acts directly on the liver to burn hepatic fat - the feature that sets it apart from pure GLP-1 drugs. In the head-to-head Phase 2a trial in NAFLD (Journal of Hepatology, 2023), efinopegdutide 10 mg cut liver fat content by 72.7% at 24 weeks versus 42.3% for semaglutide 1 mg, with two-thirds of efinopegdutide recipients falling below the 5% liver-fat threshold that defines a normal liver. Merck holds FDA Fast Track designation for the MASH program and is running Phase 2b studies plus a dedicated trial in compensated cirrhosis due to steatohepatitis; the earlier type 2 diabetes and obesity indications were discontinued in favor of the liver focus.

Metabolism (https://peptrackerpro.com/benefits/metabolism)Liver Health (https://peptrackerpro.com/benefits/liver-health)Weight Management (https://peptrackerpro.com/benefits/weight-management)Disease Modification (https://peptrackerpro.com/benefits/disease-modification)+1 more

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### Efocipegtrutide

Medium Evidence

Efocipegtrutide (Hanmi code HM15211) is an investigational, long-acting, once-weekly GLP-1/GIP/glucagon 'triple' receptor agonist being developed primarily for metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH) rather than obesity alone. It is built on Hanmi's LAPSCovery platform as a chemical conjugate of a chimeric tri-agonist peptide (TA15211) fused to a human IgG4 Fc fragment, which extends its half-life via FcRn-mediated recycling and enables weekly subcutaneous dosing. By adding glucagon-receptor activation to the GLP-1/GIP dual mechanism, efocipegtrutide is designed to combine appetite suppression and glycemic control with increased energy expenditure and direct hepatic anti-steatotic, anti-inflammatory, and anti-fibrotic effects. In a Phase 1b/2a study in obese subjects with non-alcoholic fatty liver disease, 12 weeks of treatment reduced liver fat by roughly 20% to 59% (dose-dependent, MRI-PDFF) versus about 6% on placebo. It has FDA Fast Track designation for MASH and orphan-drug designations from the FDA and EMA for primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), and idiopathic pulmonary fibrosis (IPF). The 52-week adaptive Phase 2 HM-TRIA-201 study (NCT04505436) in biopsy-confirmed MASH with fibrosis is the pivotal read the field is watching.

Liver Health: https://peptrackerpro.com/benefits/liver-health
Weight Management: https://peptrackerpro.com/benefits/weight-management
Glycemic Control: https://peptrackerpro.com/benefits/glycemic-control
Metabolism: https://peptrackerpro.com/benefits/metabolism

View Details: https://peptrackerpro.com/peptides/efocipegtrutide

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### Efpeglenatide

High Evidence

A once-weekly, long-acting GLP-1 receptor agonist from Hanmi Pharmaceutical built on a different molecular backbone than semaglutide or liraglutide: instead of a modified human GLP-1, efpeglenatide uses exendin-4 - the naturally DPP-4-resistant GLP-1 mimic first found in Gila monster venom - fused to a fragment of a human antibody (an IgG4 Fc) through a small polyethylene-glycol (mini-PEG) linker using Hanmi's LAPSCOVERY half-life-extension platform. That design lets one subcutaneous injection lower blood sugar, curb appetite and reduce body weight for a full week. Efpeglenatide is best known for the landmark AMPLITUDE-O cardiovascular outcomes trial (NEJM 2021), in which 4,076 people with type 2 diabetes and cardiovascular or kidney disease had a 27% lower rate of major adverse cardiovascular events (MACE hazard ratio 0.73) and a 32% lower rate of a composite kidney outcome (hazard ratio 0.68) versus placebo - the first cardiovascular outcomes win for an exendin-based GLP-1 and one of the clearest kidney signals in the class, with benefit seen regardless of whether patients were also taking an SGLT2 inhibitor. Originally licensed to Sanofi and then returned to Hanmi in 2020, efpeglenatide is now being advanced primarily for obesity and overweight, with a Phase 3 program that has completed enrollment and a targeted first launch in South Korea in the second half of 2026. It is an investigational (not yet approved) prescription medicine, not a supplement or research chemical.

Weight Management: https://peptrackerpro.com/benefits/weight-management
Glycemic Control: https://peptrackerpro.com/benefits/glycemic-control
Cardiovascular: https://peptrackerpro.com/benefits/cardiovascular
Kidney Health: https://peptrackerpro.com/benefits/kidney-health

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\+ Compare: https://peptrackerpro.com/compare?select=efpeglenatide
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### Efruxifermin

Medium Evidence

Efruxifermin (development codes EFX, AKR-001; originally AMG 876) is an investigational, once-weekly, subcutaneously injected analog of the metabolic hormone fibroblast growth factor 21 (FGF21) being developed by Akero Therapeutics for metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH), including both pre-cirrhotic fibrosis and compensated (F4) cirrhosis. It is a bivalent Fc-FGF21 fusion protein - two engineered FGF21 sequences fused to a human immunoglobulin (IgG1) Fc domain - a design distinct from the glycoPEGylation used by its main FGF21-class rival, pegozafermin. The Fc fusion extends the very short half-life of native FGF21 to support once-weekly dosing while preserving agonism at FGF receptors (FGFR1c/2c/3c) together with the co-receptor beta-Klotho. In the 96-week Phase 2b HARMONY trial in biopsy-confirmed F2-F3 MASH, at least a one-stage improvement in fibrosis without worsening of MASH was reached by about 75% of patients on 50 mg and 46% on 28 mg versus 24% on placebo (published in The Lancet, August 2025). In the Phase 2b SYMMETRY trial in compensated MASH cirrhosis, about 39% of 50 mg patients with paired week-96 biopsies achieved reversal of cirrhosis without worsening of MASH versus 15% on placebo (published in the New England Journal of Medicine). Efruxifermin holds FDA Breakthrough Therapy designation and has advanced into the Phase 3 SYNCHRONY program (SYNCHRONY Histology in F2-F3 MASH, SYNCHRONY Outcomes in F4 compensated cirrhosis, and SYNCHRONY Real-World in non-invasively diagnosed MASH/MASLD, whose double-blind portion completed enrollment with safety results expected in 2026).

Metabolism: https://peptrackerpro.com/benefits/metabolism

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\+ Compare: https://peptrackerpro.com/compare?select=efruxifermin
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### Pegozafermin

Medium Evidence

Pegozafermin (development code BIO89-100) is an investigational, long-acting analog of fibroblast growth factor 21 (FGF21) being developed for metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH) and for severe hypertriglyceridemia (SHTG). Originally developed by 89bio and acquired by Roche in a deal announced in September 2025 (about $2.4 billion upfront and up to roughly $3.5 billion including a contingent value right), it uses site-specific glycoPEGylation to extend the very short half-life of native FGF21 to roughly 55-100 hours, enabling once-weekly or once-every-two-weeks subcutaneous dosing. FGF21 is a metabolic hormone that acts on liver, fat, and other tissues to improve insulin sensitivity, lower triglycerides, and exert direct anti-fibrotic and anti-inflammatory effects. In the Phase 2b ENLIVEN trial in biopsy-confirmed F2-F3 MASH, the 44 mg every-two-weeks dose produced at least a one-stage fibrosis improvement without worsening of MASH in about 27% of patients versus 7% on placebo, and MASH resolution without worsening of fibrosis in about 26% versus 2% on placebo, with benefits sustained through week 48. Pegozafermin holds FDA Breakthrough Therapy designation and EMA PRIME status for MASH and has advanced into the Phase 3 ENLIGHTEN program (ENLIGHTEN-Fibrosis in non-cirrhotic F2-F3 MASH and ENLIGHTEN-Cirrhosis in compensated F4 cirrhosis), plus the Phase 3 ENTRUST trial in SHTG.

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### Retatrutide

High Evidence

An investigational triple agonist (GIP/GLP-1/glucagon) studied for obesity and metabolic disease.

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Metabolism: https://peptrackerpro.com/benefits/metabolism
Fat Loss: https://peptrackerpro.com/benefits/fat-loss

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### Semaglutide

High Evidence

A GLP-1 receptor agonist FDA-approved for type 2 diabetes and chronic weight management.

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### Survodutide

Medium Evidence

A dual GLP-1/glucagon receptor agonist with FDA Breakthrough Therapy designation for MASH and Priority Review NDA filed February 2026. Phase 3 SYNCHRONIZE-1 reported 16.6% weight loss at 76 weeks; approval possible Q3 2026.

View Details: https://peptrackerpro.com/peptides/survodutide

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### Tirzepatide

High Evidence

A dual GIP/GLP-1 receptor agonist FDA-approved for type 2 diabetes, weight management, and MASH with liver fibrosis.

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