Pemvidutide

Also known as ALT-801

InvestigationalAHuman trial evidence What this means

Pemvidutide (ALT-801) is an investigational once-weekly peptide that activates both the GLP-1 and glucagon receptors with closely matched potency. It has been studied in randomized placebo-controlled trials in fatty liver disease, and a phase 3 trial in MASH was registered in 2026. It is not an approved medicine, and this entry is for research information only.

US status: Investigational
Evidence: Grade A
Half-life: A numerical human half-life was not located in the sources reviewed
Class: Dual GLP-1 receptor / glucagon receptor agonist (investigational)

Studied in: Appetite & body weight · Metabolic & insulin research · Class: GIP and glucagon co-agonists

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Key takeaways

In a 12-week randomized phase 1 trial in 94 adults with MASLD, relative liver-fat reductions were 46.6% (1.2 mg), 68.5% (1.8 mg) and 57.1% (2.4 mg) versus 4.4% with placebo ^1.
In a 12-week blinded extension (64 participants, 24 weeks of treatment in total), relative liver-fat reductions were 56.3%, 75.2% and 76.4% versus 14.0% with placebo, and body weight fell by 6.2% in the 1.8 mg group ^2.
In the 24-week IMPACT phase 2b trial in biopsy-confirmed MASH with F2-F3 fibrosis, MASH resolution without fibrosis worsening was reported in 58% (1.2 mg) and 52% (1.8 mg) versus 20% with placebo; the second primary endpoint, fibrosis improvement, was not met ^3.
Adverse events in IMPACT were reported in 78% and 81% of pemvidutide recipients versus 67% with placebo, mostly mild or moderate ^3.
Pemvidutide has not been approved by the FDA, and peer-reviewed results of its obesity trial (MOMENTUM) were not located for this entry ^5,9.

Development stage

Where Pemvidutide sits between laboratory work and regulatory approval.

Preclinical
Animal and cell work
Phase 1
First human safety studies
Phase 2
Early efficacy signal
Phase 3 (current)
Confirmatory trials
Approved
Cleared by a regulator

Stage comes from the regulatory record and ClinicalTrials.gov studies naming the compound (for compounds approved nowhere, only completed trials or trials with posted results count) (checked 2026-10-24). A registered trial is not a result.

Mechanism of action

Pemvidutide (ALT-801) is described as a dual GLP-1 receptor (GLP-1R) and glucagon receptor (GCGR) peptide agonist conjugated to a glycolipid moiety that slows absorption into the plasma and prolongs half-life ⁴.

Balanced receptor potency

The preclinical report gives closely matched potencies of 39 pM at GLP-1R and 42 pM at GCGR, and contrasts this with other dual agonists that the authors describe as biased towards GLP-1R ⁴. The authors cite earlier work in which a dual agonist with near-balanced activity at both receptors was associated with the greatest body-weight reduction and glycaemic control ⁴.

Rationale for liver disease

The trial authors describe glucagon receptor agonists as acting directly on the liver to stimulate fatty acid oxidation and inhibit lipogenesis, whereas GLP-1R agonists act mainly through central and peripheral effects on appetite ^1,2. This rationale comes from the developer's publications, and the relative contribution of each receptor in people has not been isolated in the sources reviewed ^1,2.

Research overview

Human research

Pemvidutide has been studied in a 12-week randomized placebo-controlled trial in adults with MASLD ^1, its 12-week blinded extension ² and a 24-week analysis of the phase 2b IMPACT trial in biopsy-confirmed MASH with F2-F3 fibrosis ^3. Registered trials also cover obesity (MOMENTUM) ^5, alcohol use disorder (RECLAIM) ^7, alcohol-associated liver disease (RESTORE) ⁸ and a phase 3 MASH outcomes trial (PERFORMA) ^6.

Animal research

In biopsy-confirmed diet-induced obese mice with NASH, 12 weeks of ALT-801 reduced body weight by approximately 25% and improved liver steatosis, plasma aminotransferases and markers of inflammation and fibrosis, with greater reductions than semaglutide and elafibranor on several measures ^4.

In-vitro research

Potency values of 39 pM at GLP-1R and 42 pM at GCGR are cited in the preclinical report from earlier work by the same group ^4.

Key studies

Harrison et al., J Hepatol (2025)
Randomized, double-blind, placebo-controlled, 12 weeks (NCT05006885)
Model: Humans (94 adults with MASLD and BMI of 28 or more; 29% with type 2 diabetes)
Relative liver-fat reductions were 46.6%, 68.5% and 57.1% at 1.2, 1.8 and 2.4 mg versus 4.4% with placebo; at 1.8 mg, 94.4% reached a 30% reduction and 55.6% reached normal liver fat (5% or less), and body weight fell by 4.3% ^1.
Browne et al., JHEP Rep (2025)
Double-blind 12-week extension, 24 weeks of treatment in total (NCT05292911)
Model: Humans (64 completers of the parent MASLD trial)
Relative liver-fat reductions were 56.3%, 75.2% and 76.4% versus 14.0% with placebo; at 1.8 mg, 84.6% reached a 50% reduction and body weight fell by 6.2% ^2.
Noureddin et al., Lancet (IMPACT) (2025)
Randomized (1:2:2), double-blind, placebo-controlled phase 2b; 24-week analysis of an ongoing 48-week trial
Model: Humans (212 adults with biopsy-confirmed MASH, fibrosis F2-F3)
MASH resolution without fibrosis worsening occurred in 58% (1.2 mg) and 52% (1.8 mg) versus 20% with placebo; fibrosis improvement without MASH worsening was 33% and 36% versus 28% and did not differ significantly from placebo ^3.
Nestor et al., Sci Rep (2022)
Preclinical comparison with semaglutide and elafibranor, 12 weeks
Model: Diet-induced obese mice with biopsy-confirmed NASH
ALT-801 reduced body weight by approximately 25% and lowered plasma aminotransferases, plasma cholesterol and liver lipids, with greater reductions than both comparators ^4.

Doses used in published trials

What investigators administered in the cited studies, recorded as a fact about those studies. Not a protocol and not a recommendation.

Full dosing reference, study durations and vial arithmetic →

In the phase 1 MASLD trial (NCT05006885), participants were randomized 1:1:1:1 to once-weekly subcutaneous pemvidutide at 1.2 mg, 1.8 mg or 2.4 mg, or placebo, for 12 weeks ^1.
In the extension trial (NCT05292911), completers continued their originally assigned dose without titration for a further 12 weeks ^2.
In IMPACT (NCT05989711), participants were randomized 1:2:2 to once-weekly subcutaneous pemvidutide 1.2 mg or 1.8 mg, given without dose titration, or placebo ^3,12.
The PERFORMA phase 3 registration (NCT07795164) lists pemvidutide 1.8 mg and 2.4 mg and placebo arms, an estimated enrolment of 1,800 and histological endpoints at week 52 ^6.
In the phase 1 MASLD trial, 94 participants were randomized and dosed ^1; 64 completers entered the 12-week extension ^2.
IMPACT randomized 212 participants with biopsy-confirmed MASH and fibrosis stage F2 or F3: 41 to pemvidutide 1.2 mg, 85 to 1.8 mg and 86 to placebo ^3.
The MOMENTUM obesity trial registry record (NCT05295875) lists three ALT-801 (pemvidutide) dose levels and placebo, 391 participants enrolled and a week-48 body-weight primary endpoint; dose amounts are not stated in the registry fields and no results are posted ^5.
The RECLAIM phase 2 registry record (NCT06987513) lists pemvidutide 2.4 mg versus placebo in 100 participants with alcohol use disorder and obesity or overweight, with the primary endpoint over weeks 21–24 ^7.
The RESTORE phase 2 registry record (NCT07009860) lists pemvidutide 2.4 mg versus placebo in 121 participants with alcohol-associated liver disease, with liver-stiffness endpoints at weeks 24 and 48 ^8.

Pemvidutide draw calculator

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Water	mg/mL	Draw
0.5 mL	20	—
1 mL	10	—
1.5 mL	6.667	—
2 mL	5	—
2.5 mL	4	—
3 mL	3.333	—
5 mL	2	—

Published adverse-event data

Reported in the cited trials or product labels. Frequencies apply to the stated population and do not transfer to other settings.

Any adverse event
78% (1.2 mg) and 81% (1.8 mg) versus 67% placebo
IMPACT, adults with MASH F2-F3, 24 weeks ³ · Majority mild or moderate
Discontinuation due to adverse events
0% (1.2 mg) and 1% (1.8 mg) versus 2% placebo
IMPACT, 24 weeks ³ · Led to treatment discontinuation
Severe or serious adverse events
None reported
Phase 1 MASLD trial, 12 weeks ¹ · Not applicable
Nausea
33.3% of pemvidutide recipients during the extension phase
MASLD extension trial (weeks 12-24) ² · Mostly mild to moderate
Discontinuation due to adverse events
2 of 16 (1.2 mg) and 1 of 15 (1.8 mg); none with 2.4 mg or placebo
MASLD extension trial ² · Led to treatment discontinuation

Emerging safety signals

IMPACT doses were given without titration, and the trial reported higher overall adverse-event rates with pemvidutide (78-81%) than with placebo (67%); the published report covers 24 of the planned 48 weeks ^3. ³ (2025)
In the 24-week MASLD extension, the authors reported no significant change in heart rate with pemvidutide, but the trial had only 64 participants ^2. ² (2025)

What is not known: No regulatory approval exists, so there is no label. A human elimination half-life was not located in the sources reviewed. The published IMPACT report covers 24 weeks, and the fibrosis primary endpoint was not met at that point. Results of the 48-week MOMENTUM obesity trial were not found in the peer-reviewed literature. Long-term clinical outcomes are the subject of the registered PERFORMA phase 3 trial, which lists clinical outcome events through approximately month 60. All published trials were funded by the developer, and several authors are company employees.

Background viewing

We haven't found a clinician video focused on Pemvidutide yet. Meanwhile, this widely watched talk covers the science of aging in general. It does not discuss Pemvidutide.

David Sinclair, PhD (Harvard Medical School) on the biology of aging

The Diary Of A CEO · 6.9M views · 2026

These creators are not affiliated with Amiravo and do not endorse Amiravo or any product linked on this site. Nothing here is medical advice. Video views counted on YouTube as of Oct 24, 2026.

Regulatory status

Status: Investigational as of 22 October 2026. An openFDA query of Drugs@FDA on that date returned no application record for pemvidutide ^9, and a phase 3 trial in MASH is registered as recruiting ^6.
United States (FDA): Pemvidutide is investigational; an openFDA query of Drugs@FDA application data on 22 October 2026 returned no application record for it ^9.
Sport (WADA): Pemvidutide is not named in the 2026 Prohibited List text reviewed. Section S0 covers pharmacological substances not addressed elsewhere on the List that have no current approval by any governmental regulatory health authority for human therapeutic use, including drugs under clinical development; athletes should consult WADA directly ^10.

Status varies by country and changes over time. How we describe regulatory status.

Quality and testing notes

No PubChem compound record for pemvidutide was returned on 22 October 2026, so a reference molecular weight could not be verified for this entry [11]. A certificate of analysis for a pemvidutide research material would be expected to show HPLC purity, mass-spectrometry identity, endotoxin and net peptide content, and should state how the glycolipid conjugation described in the literature was confirmed [4].

How purity testing works · Reading a certificate of analysis

Check a Pemvidutide certificate of analysis

Storage and handling

Storage conditions for research material are set by the supplier's documentation; lyophilized peptides are generally sensitive to heat, light and moisture.

Frequently asked questions

What is pemvidutide?

Pemvidutide (ALT-801) is an investigational peptide that activates both the GLP-1 receptor and the glucagon receptor, conjugated to a glycolipid moiety intended to support weekly dosing ^4.

Is pemvidutide approved by the FDA?

No. An openFDA query of Drugs@FDA on 22 October 2026 returned no application record ^9.

What does "balanced" dual agonism mean here?

The developer reports near-equal potency at the two receptors (39 pM at GLP-1R and 42 pM at GCGR), in contrast to dual agonists it describes as biased towards GLP-1R ^4.

What did the MASH trial show?

At 24 weeks in IMPACT, MASH resolution without fibrosis worsening was more frequent with pemvidutide (52-58%) than placebo (20%), but fibrosis improvement did not differ significantly from placebo ^3.

Has it been studied for obesity?

A 48-week phase 2 obesity trial (MOMENTUM) is registered as completed ^5. Peer-reviewed results were not located for this entry, though the liver trials reported body-weight reductions of 4.3-6.2% at the 1.8 mg dose ^1,2.

What else is it being studied for?

Registered phase 2 trials cover alcohol use disorder and alcohol-associated liver disease, and a phase 3 MASH outcomes trial is recruiting ^6,7,8.

Latest indexed research

No new studies were filed in the last sweep.

Search all studies on Pemvidutide (PubMed, Europe PMC, ClinicalTrials.gov)

Listed by publication type from the index record. Inclusion is not an endorsement; open the source to read the findings.

Revision history

Meaningful changes to this entry, with dates and sources. Last reviewed Oct 23, 2026. Typo and layout fixes are not listed.

New section· Schedules by time periodOct 23, 2026
Added week-by-week schedules from registered trials (1 group, 2 arms).
Source: 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

References

Last reviewed October 23, 2026 by the Amiravo editorial team.

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Specifications

Format: Lyophilized vial
Type: Single compound

Chemical identifiers are shown only when verified against PubChem.

Research stats

How much has been published, not how good it is.

PubMed records: 16
Indexed as human research: 9
Animal-only research: 1
Randomized controlled trials: 2
Registered trials: 16
Trials with posted results: 5
NIH-funded projects naming it: 6

PubMed records per year (current year is partial).

Counts from title/abstract searches of PubMed, ClinicalTrials.gov, openFDA and NIH RePORTER, checked 2026-10-24. Names shared with other substances can inflate counts. FAERS reports are spontaneous and do not establish cause. Funding shows interest, not evidence. Method

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