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Metabolic

Pemvidutide

Also known as: ALT-801

Clinical Trials
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Key Facts: Pemvidutide

Category
Metabolic
FDA Status
Not FDA Approved
Clinical Status
Phase 3 (investigational) - PERFORMA phase 3 trial in MASH with F2-F3 fibrosis started August 2026 (52-week readout expected 2029). FDA Breakthrough Therapy designation for MASH; Fast Track for MASH and alcohol use disorder. Not approved by FDA or any other regulator.
Banned in Sport (WADA)
Not named on the WADA list, but WADA's S0 catch-all bans any substance without human therapeutic approval, which covers it until it is approved. Prohibited at all times.
Administration
Subcutaneous injection once weekly
Typical Dose
1.2-1.8 mg once weekly (MASH trial doses)
Frequency
Once weekly
Duration
24-48 weeks in completed trials; phase 3 runs 52 weeks for the biopsy endpoint and years for outcomes
Also Known As
ALT-801

How does Pemvidutide work?

Pemvidutide activates two receptors in roughly balanced fashion. The GLP-1 side cuts appetite and slows stomach emptying, like semaglutide. The glucagon side acts directly on the liver, pushing it to burn fat and raising energy expenditure, which is why this drug class is especially interesting for fatty liver. Altimmune attaches its EuPort domain to stretch the half-life for weekly dosing and, the company says, to slow absorption for better tolerability. Glucagon activity can raise blood sugar on its own, so balancing the two signals is the design challenge. Most of the mechanism story comes from the company and is plausible, but independent data are limited.

What does the research show?

In the phase 2 MOMENTUM obesity trial (391 adults without diabetes, 48 weeks), the 2.4 mg weekly dose produced 15.6% mean weight loss versus 2.2% on placebo, and a small MRI sub-study (50 people) found about 78% of the weight lost was fat. The focus then shifted to MASH. The phase 2b IMPACT trial randomized 212 people with biopsy-confirmed MASH and F2-F3 fibrosis to 1.2 mg, 1.8 mg or placebo. At 24 weeks, MASH resolution was 59.1% and 52.1% versus 19.1% on placebo, a strong result. But fibrosis improvement (31.8% and 34.5% versus 25.9%) was not statistically significant, and the stock fell by more than half on the news in June 2025. The 48-week data (December 2025) showed significant improvements in non-invasive fibrosis markers (ELF score and liver stiffness) and continued weight loss without a plateau, with fewer dropouts for side effects than placebo. The PERFORMA phase 3 trial (about 1,790 people, titrating to 1.8 or 2.4 mg) began in August 2026, with a 52-week biopsy readout expected in 2029. A separate phase 2 trial in alcohol use disorder (RECLAIM) reported positive topline results in July 2026. Bottom line: strong on liver fat and MASH resolution, still unproven on the fibrosis outcomes regulators care most about.

Trial Progress:Phase III
Pre
I
II
III
IV
FDA

What doses have been studied?

Human Trials·Phase 2 obesity and MASH trials completed, phase 3 MASH trial started August 2026

Typical Dosingⓘ

Community experience

Common Dose

1.2-1.8 mg once weekly (MASH trial doses)

Range

1.2-2.4 mg weekly in trials

Frequency

Once weekly

These are phase 2 and phase 3 trial doses, not recommendations. Phase 3 titrates monthly from 1.2 mg to reach the trial dose. No dose has been approved for any use.

Research Dosingⓘ

Scientific studies

Trial doses only (investigational drug, no approved dose)

Duration

24-48 weeks in completed trials; phase 3 runs 52 weeks for the biopsy endpoint and years for outcomes

Administration

Subcutaneous injection once weekly

When and how is Pemvidutide taken?

Best Time to Take

Same day each week

Once weekly subcutaneous injection

Food Recommendation

With or without food

Why This Timing?

Long-acting weekly peptide, so steady weekly timing keeps levels consistent. Time of day is not specified in the trial reports.

What are the side effects of Pemvidutide?

Not everyone experiences these effects. Individual responses vary based on dosage, duration, and personal factors.

  • ●Nausea
  • ●Vomiting
  • ●Diarrhea
  • ●Mostly mild to moderate GI effects during titration
  • ●Possible effects on blood sugar from glucagon activity (watch in diabetes)
  • ●Increased heart rate seen with incretin-class drugs
  • ●No long-term or outcomes safety data yet

References

Research This Peptide Further

Frequently Asked Questions

What does Pemvidutide do?

Pemvidutide is Altimmune's once-weekly GLP-1/glucagon dual agonist, now being developed mainly for MASH (fatty liver disease with inflammation, formerly called NASH). It cleared fat out of the liver fast in trials and earned FDA Breakthrough Therapy designation, and its phase 3 trial (PERFORMA) started in August 2026. It also produced decent weight loss in an obesity trial, but it is not approved anywhere and its biggest phase 2 MASH trial missed on the fibrosis endpoint at 24 weeks.

How does Pemvidutide work?

Pemvidutide activates two receptors in roughly balanced fashion. The GLP-1 side cuts appetite and slows stomach emptying, like semaglutide. The glucagon side acts directly on the liver, pushing it to burn fat and raising energy expenditure, which is why this drug class is especially interesting for fatty liver. Altimmune attaches its EuPort domain to stretch the half-life for weekly dosing and, the company says, to slow absorption for better tolerability. Glucagon activity can raise blood sugar on its own, so balancing the two signals is the design challenge. Most of the mechanism story comes from the company and is plausible, but independent data are limited.

Is Pemvidutide FDA approved?

No, Pemvidutide is not currently FDA approved. Current status: Phase 3 (investigational) - PERFORMA phase 3 trial in MASH with F2-F3 fibrosis started August 2026 (52-week readout expected 2029). FDA Breakthrough Therapy designation for MASH; Fast Track for MASH and alcohol use disorder. Not approved by FDA or any other regulator.

Is Pemvidutide banned in sport?

Not named on the WADA list, but WADA's S0 catch-all bans any substance without human therapeutic approval, which covers it until it is approved. Prohibited at all times.

What are the side effects of Pemvidutide?

Reported side effects include: Nausea, Vomiting, Diarrhea, Mostly mild to moderate GI effects during titration, Possible effects on blood sugar from glucagon activity (watch in diabetes). Individual responses vary based on dosage, duration, and personal health factors.

What is the typical dose of Pemvidutide?

Community-reported common dose: 1.2-1.8 mg once weekly (MASH trial doses) (Once weekly). Range: 1.2-2.4 mg weekly in trials. Administration: Subcutaneous injection once weekly. Community-reported doses. Not medical advice. Consult healthcare provider.

Related Peptides

Peptides commonly compared with Pemvidutide or used in similar applications.

THR-123

Preclinical

THR-123 is a small synthetic 16-residue cyclic peptide designed to mimic part of the protein BMP7 (bone morphogenetic protein 7) and switch on its receptor, ALK3, in the kidney. It was developed by Thrasos Therapeutics and made famous by a 2012 Nature Medicine paper showing that, taken orally, it could reverse kidney fibrosis and trigger kidney regeneration in mice. It is a preclinical research compound with no human trials of its own, though its intravenous sibling THR-184 reached Phase 2 for acute kidney injury.

Metabolic

AICAR

Clinical Trials

AICAR is not a peptide at all. It is a small nucleoside (a building block related to the purine pathway) that cells convert into ZMP, a molecule that mimics AMP and switches on AMPK, the cell's energy sensor. It became famous in 2008 when a Salk Institute study showed sedentary mice on AICAR ran 44% further, earning it the "exercise in a pill" label. Human data tell a much less exciting story: it was tested as an intravenous drug (acadesine) for heart surgery and leukemia, the big heart trial failed, and nothing is approved.

Metabolic

Pancragen

Clinical Trials

Pancragen is a synthetic tetrapeptide bioregulator, Lys-Glu-Asp-Trp (KEDW), from the Khavinson group, designed to target pancreatic tissue. It is studied for supporting blood-sugar control and the insulin-producing endocrine pancreas, especially in aging. It is a research compound with no approval and no published human clinical trials. The notable evidence comes from aged primates, not people.

Metabolic

Lixisenatide

FDA

Lixisenatide is a short-acting, once-daily GLP-1 agonist for type 2 diabetes, discovered by Zealand Pharma and sold by Sanofi as Adlyxin (US) and Lyxumia (EU). It never caught on against weekly GLP-1 drugs, and it has mostly left the market: standalone Adlyxin was discontinued in the US with last availability around January 2023, and the EU authorisation for Lyxumia was withdrawn in December 2025. It lives on in Soliqua 100/33, a fixed combination with insulin glargine.

Metabolic

Pramlintide

FDA

Pramlintide (Symlin) is a synthetic version of amylin, the hormone your pancreas releases alongside insulin, and it was the first amylin drug ever approved (FDA, March 2005). It was used as a mealtime add-on for type 1 and type 2 diabetes in people already on mealtime insulin. It never sold well because it meant up to three extra injections a day and a serious hypoglycemia warning, and AstraZeneca has discontinued it in the US. Today it matters mostly as the proof of concept behind newer weekly amylin drugs like cagrilintide and petrelintide.

Metabolic

SLU-PP-332

Preclinical

SLU-PP-332 is a small synthetic molecule, not a peptide, that turns on the estrogen-related receptors (ERRalpha, beta and gamma), the master switches behind much of the body's response to endurance exercise. Researchers call it an 'exercise mimetic' because in mice it boosts mitochondria, shifts muscle toward fatigue-resistant fibers, improves stamina and trims fat without the animal moving more. It was made as a lab tool to study exercise biology. There are no human trials.

Metabolic

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