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Peptide Reference Guide

Pemvidutide: Dose References, IMPACT MASH Data & Phase 3 Status

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Quick Reference Card

Attribute

Identity

Research reference
Pemvidutide, Altimmune investigational peptide with balanced 1:1 glucagon/GLP-1 receptor agonist activity. [1][2]

Attribute

Main development focus

Research reference
MASH, with additional development in alcohol use disorder and alcohol-associated liver disease. [1][3]

Attribute

Route studied

Research reference
Once-weekly subcutaneous injection in MASH, MASLD and AUD trials. [4][5][6]

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Current status

Research reference
Investigational. PERFORMA phase 3 MASH trial was initiated in August 2026 and is actively enrolling; no approval identified. [1][2]

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FDA designations

Research reference
Fast Track for MASH and AUD; Breakthrough Therapy Designation for MASH, according to Altimmune. [1][2]

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Evidence boundary

Research reference
Positive phase 2b MASH-resolution data coexist with an unproven conventional biopsy fibrosis endpoint at 24 weeks. AI pathology and non-invasive fibrosis signals should be labeled separately. [4][7]

Quick dose reference

Pemvidutide is investigational and has no approved label. This summary summarizes cited MASH and phase 3 target doses. Any dosing protocol should be reviewed with a qualified healthcare practitioner.

Investigational pemvidutide injected under the skin (subcutaneous)

Based on clinical study details

IMPACT 1.8 mg MASH target

Amount studied
1.8 mg
Frequency
Once weekly
Duration
24-48 weeks
Dose adjustment
Assigned trial arm; 48-week follow-up retained same arm
Reported range & limits
IMPACT studied 1.2 and 1.8 mg weekly. The 1.8 mg target is not an approved maximum or safe upper limit.
Evidence and range contextReview the full source references below.
IMPACT 1.8 mg MASH target

This is the higher IMPACT MASH target and keeps biopsy-confirmed MASH context visible.

IMPACT also included a 1.2 mg weekly arm; neither is an approved label dose.

Investigational pemvidutide injected under the skin (subcutaneous)

Based on clinical study details

PERFORMA 2.4 mg phase 3 target

Amount studied
2.4 mg
Frequency
Once weekly
Duration
52-week primary readout planned
Dose adjustment
Monthly titration from 1.2 mg to 2.4 mg trial dose
Reported range & limits
PERFORMA includes 1.8 and 2.4 mg targets. The 2.4 mg row is a study target, not a proven safe upper limit.
Evidence and range contextReview the full source references below.
PERFORMA 2.4 mg phase 3 target

This captures the registrational high target while making clear results were not yet available in the checked source.

PERFORMA also includes a 1.8 mg target; the row selects the high target rather than reporting a pooled range.

Full Dosing Reference SourcesClinical research, registered studies and online dosing sources, with their context and limitations.

Pemvidutide rows should preserve disease context: MASLD, biopsy-confirmed MASH, AUD, and phase 3 design are not interchangeable.

Published MASLD trial extension

1.2, 1.8 or 2.4 mg once weekly; 64 completers continued their randomized 12-week treatment for another 12 weeks.

Route / formulation
Subcutaneous investigational pemvidutide
What this does and does not show
Shows liver-fat and weight effects in MASLD. MASLD without biopsy-confirmed MASH fibrosis is not the same population as IMPACT or PERFORMA.

IMPACT phase 2b MASH trial, 24-week biopsy endpoints

1.2 or 1.8 mg once weekly versus placebo for 24 weeks in adults with biopsy-confirmed MASH and F2/F3 fibrosis.

Route / formulation
Subcutaneous investigational pemvidutide
What this does and does not show
Shows MASH-resolution separation from placebo and no statistically significant conventional fibrosis-improvement separation at 24 weeks.

IMPACT phase 2b MASH trial, 48-week follow-up

Same 1.2 or 1.8 mg weekly treatment arms followed through 48 weeks.

Route / formulation
Subcutaneous investigational pemvidutide
What this does and does not show
Shows longer metabolic and non-invasive fibrosis-marker follow-up. These markers support, but do not replace, biopsy endpoints for final regulatory interpretation.

PERFORMA phase 3 MASH trial

Simple monthly titration from 1.2 mg to 1.8 mg or 2.4 mg trial doses. Cohort 1 planned for about 990 biopsy-assessed patients; cohort 2 planned for about 800 patients with fibrosis evidenced through non-invasive tests.

Route / formulation
Subcutaneous investigational pemvidutide
What this does and does not show
Shows the current registrational dose strategy and phase 3 design. It does not provide results; 52-week readout is anticipated in 2029.

RECLAIM phase 2 alcohol use disorder trial

2.4 mg pemvidutide was reported as the dose that met the primary heavy-drinking-days endpoint.

Route / formulation
Subcutaneous investigational pemvidutide
What this does and does not show
AUD biology and endpoints differ from MASH. This row explains program breadth, not a liver-disease dose recommendation.

28 inspected pemvidutide sources were included. Human evidence is trial-only, centered on weekly subcutaneous 1.2, 1.8 and 2.4 mg programs; no approved label or independent public regimen was found.

Applicable product labels and human studies carry the most weight. A registry entry does not establish study results. Animal studies, public guides and forums add context; they do not establish a safe human dose limit.

Official product and regulatory sources

Human clinical research

Registered clinical trials

Published evidence reviews

Contradictions and open gaps

IMPACT can sound contradictory if the endpoints are collapsed. The 24-week trial met its MASH-resolution endpoint, and sponsor analyses reported AI-based fibrosis reductions plus supportive non-invasive tests. The conventional biopsy endpoint of fibrosis improvement without worsening of MASH was numerically higher with pemvidutide but not statistically significant in the intent-to-treat analysis. Both statements are true and should remain separated. [4][7]

PERFORMA is active and important, but it is a future-results trial. It can support current development status and dose selection, not efficacy claims. The 52-week interim data are anticipated in 2029, and final approval-oriented liver-event outcomes require longer event-driven follow-up. [2]

What is pemvidutide?

Pemvidutide is an investigational peptide from Altimmune designed to activate glucagon and GLP-1 receptors in a balanced 1:1 ratio. The development strategy is liver-centered: glucagon receptor activity is intended to act directly on liver fat and inflammatory biology, while GLP-1 receptor activity contributes appetite, weight and broader cardiometabolic effects. [1][2]

The compound uses Altimmune's EuPort domain to prolong exposure and support weekly dosing. That engineering detail explains the clinical dosing interval; it does not make gray-market materials equivalent to the sponsor's study product. [1]

Mechanism and evidence balance

Pemvidutide GLP-1 and glucagon receptor pathways, with weight, liver fat, MASH resolution and fibrosis as distinct trial endpoints.

Schematic illustration; receptor shapes are symbolic. The mechanism does not establish a dose or predict an individual outcome.

Pemvidutide belongs to the GLP-1/glucagon dual-agonist class rather than the GLP-1/GIP class. The mechanistic wager is different from a pure weight-loss incretin: glucagon receptor activity may increase hepatic fat oxidation and produce liver-directed effects, while GLP-1 receptor activity can reduce appetite and improve metabolic measures. [1]

Human MASH evidence is stronger than preclinical inference in this guide. IMPACT provides biopsy-based phase 2b data in F2/F3 MASH, and PERFORMA is now the registrational test of whether those signals translate to phase 3 endpoints. Preclinical and molecular-design claims help explain why the compound exists, but they do not prove fibrosis reversal or clinical-outcome benefit. [1][2][4]

Research and clinical evidence

MASLD and liver-fat studies

The earlier 24-week MASLD trial tested 1.2, 1.8 and 2.4 mg weekly doses. The published extension reports relative liver-fat reductions by MRI-PDFF of 56.3%, 75.2% and 76.4% with pemvidutide versus 14.0% with placebo, and body-weight reduction up to 6.2%. Those findings support antisteatotic activity, but MASLD liver-fat reduction is not the same as biopsy-proven MASH resolution or fibrosis improvement. [5]

IMPACT phase 2b MASH trial

IMPACT enrolled 212 participants with biopsy-confirmed MASH and F2/F3 fibrosis, with and without diabetes. Participants received weekly subcutaneous pemvidutide 1.2 mg, pemvidutide 1.8 mg or placebo. The 24-week intent-to-treat analysis counted missing biopsies as non-responders. [4]

MASH resolution without worsening of fibrosis occurred in 59.1% of the 1.2 mg group and 52.1% of the 1.8 mg group versus 19.1% with placebo. Fibrosis improvement without worsening of MASH occurred in 31.8% and 34.5% with pemvidutide versus 25.9% with placebo, a difference the sponsor reported as not statistically significant. Weight loss reached 5.0% and 6.2% with pemvidutide versus 1.0% with placebo, and liver-fat reductions were 58.0% and 62.8% versus 16.2%. [4]

The 48-week EASL 2026 update highlighted metabolic and non-invasive fibrosis-marker signals. For the 1.8 mg dose, Altimmune reported triglyceride reductions of 23.7%, total cholesterol reductions of 15.4%, 7.5% weight loss with no plateau, waist reduction of 5.3 cm and blood-pressure reductions. The same release repeated prior combined non-invasive fibrosis-marker results: at week 48, both a 0.5 or greater ELF reduction and a 30% or greater liver stiffness reduction occurred in 27.8% of the 1.2 mg group and 32.4% of the 1.8 mg group versus 3.2% with placebo. [7]

PERFORMA phase 3 trial

Altimmune announced on August 3, 2026 that PERFORMA had begun enrolling patients. PERFORMA is a global, randomized, double-blind, placebo-controlled phase 3 trial in adults with MASH and confirmed F2/F3 fibrosis. Cohort 1 is designed to support accelerated approval using biopsy-assessed MASH resolution and/or fibrosis improvement at 52 weeks. Cohort 2 adds a larger safety population with fibrosis evidenced through non-invasive tests. Both cohorts support final approval based on liver-related events at about 60 months. [2]

The trial's dose strategy is more explicit than many early programs: monthly titration from 1.2 mg to either 1.8 mg or 2.4 mg trial doses. That phase 3 design is not a recommendation; it is the sponsor's controlled investigational regimen. [2]

Safety and tolerability

In the 24-week IMPACT release, adverse-event related discontinuations were 0.0% at 1.2 mg and 1.2% at 1.8 mg versus 2.4% on placebo. No serious adverse events related to study drug and no arrhythmias were reported at 24 weeks. At 48 weeks, Altimmune said the majority of adverse events were mild to moderate, most gastrointestinal events occurred within the first 8 weeks, and no imbalance in cardiac adverse events was observed. [4][7]

Those results do not settle long-term safety. Larger phase 3 exposure is needed for rare hepatic events, gallbladder events, pancreatitis, cardiovascular outcomes, psychiatric signals, renal tolerability during dehydration, pregnancy exposure and alcohol-related populations. The glucagon component also makes it important to track glucose, lipids, liver enzymes and weight trajectory together rather than treating pemvidutide as a generic GLP-1 substitute.

Administration and tracking

Pemvidutide trial records are unusually liver-focused, so a record should include both metabolic and hepatic measures when available: dose, injection timing, titration step, weight, waist, appetite, gastrointestinal symptoms, alcohol intake when relevant, liver enzymes, lipid panels, glucose or HbA1c, FibroScan or other non-invasive tests, and biopsy context when applicable.

Doserly can organize a documented clinician-directed regimen and related measurements. It does not diagnose MASH, interpret fibrosis or determine whether an investigational compound is appropriate.

What to monitor in the evidence

The next decisive milestone is PERFORMA's 52-week interim biopsy readout, expected in 2029. Before then, useful updates include a peer-reviewed IMPACT 48-week paper, full safety tables, PERFORMA registry details, and clarification of how AIM-MASH AI Assist is used alongside conventional pathology. Claims that pemvidutide is antifibrotic should distinguish biopsy-stage improvement, digital pathology measures and non-invasive tests.

Frequently asked questions

Is pemvidutide FDA-approved?

No. It is investigational. Altimmune reports Fast Track designation for MASH and AUD and Breakthrough Therapy Designation for MASH, but those designations are not approval. [1][2]

What dose of pemvidutide has been studied for MASH?

IMPACT studied 1.2 mg and 1.8 mg once weekly. PERFORMA uses monthly titration from 1.2 mg to 1.8 mg or 2.4 mg trial doses. [2][4]

Did IMPACT prove fibrosis improvement?

The conventional 24-week biopsy endpoint of fibrosis improvement without worsening of MASH was not statistically significant in the sponsor's ITT analysis. Sponsor-reported AI pathology and non-invasive fibrosis markers were more favorable. These are different evidence categories and should not be merged. [4][7]

Is pemvidutide mainly a weight-loss peptide?

No. Weight loss is part of the program, but Altimmune's lead development focus is serious liver disease, especially MASH. The glucagon/GLP-1 mechanism is being tested for both hepatic and metabolic effects. [1][2]

Does the glucagon component make it unsafe for diabetes?

The available trial releases include participants with and without diabetes and report minimal HbA1c changes in IMPACT, but individual glucose risk cannot be inferred from topline statements. Diabetes-specific use would require clinical supervision and trial or label evidence. [4]

Sources & References

[1] Altimmune. Pemvidutide product page. Reviewed September 12, 2026.

[2] Altimmune / GlobeNewswire. Altimmune initiates PERFORMA phase 3 trial of pemvidutide in MASH. August 3, 2026.

[3] Altimmune. Clinical trials page. Reviewed September 12, 2026.

[4] Altimmune. Positive topline IMPACT phase 2b 24-week MASH results. June 26, 2025.

[5] Browne SK, et al. Safety and efficacy of 24 weeks of pemvidutide in MASLD. JHEP Reports. 2025;7:101483. DOI: 10.1016/j.jhepr.2025.101483.

[6] Altimmune SEC exhibit. RECLAIM phase 2 topline results in alcohol use disorder. July 28, 2026.

[7] Altimmune. 48-week IMPACT phase 2b metabolic results at EASL 2026. May 28, 2026.

[8] Altimmune. New IMPACT analyses with non-invasive markers and qFibrosis. May 27, 2026.

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