Pemvidutide Reference
Educational, not medical advice reference for Pemvidutide: GLP-1, Fat Loss; regulatory status, evidence posture, source review, and schedule not…
Plain English
- What it is
- Pemvidutide (also called ALT-801) is an experimental medicine made by a company called Altimmune. It works on two of the body's appetite and metabolism signals at once, called GLP-1 and glucagon. It is investigational, which means the FDA has not approved it and it is only available inside clinical trials, so anything sold online as pemvidutide is not the drug being tested.
- What people use it for
- In research, it is being tested mainly for a fatty-liver disease called MASH (metabolic dysfunction-associated steatohepatitis), and it is also being studied for obesity and alcohol-related liver problems. In the trials it is given as an injection under the skin. It is not approved for any of these uses.
- What the science shows
- A mid-stage human study (called IMPACT) in adults with confirmed MASH found that far more people taking pemvidutide had their liver disease clear up without their liver scarring getting worse, compared with people given a placebo (a dummy treatment). In that study the drug was generally well tolerated, and most side effects were mild or moderate. Longer results came in late 2025, and in early 2026 the FDA gave it a 'Breakthrough Therapy' label, a status meant to speed up review of promising drugs.
- The catch
- Pemvidutide is still experimental and not FDA-approved, so its long-term safety and real benefits are not settled yet. The strongest evidence so far comes from one mid-stage trial, and a larger, final-stage study is only planned and has not begun. Because it is not approved, it is not legally sold outside clinical trials, and any product marketed online as pemvidutide is not the studied drug and has not been checked for what it actually contains.
Reference summary
The IMPACT Phase 2b MASH trial (Lancet 2025, PMID 41237796) reported 24-week MASH-resolution and fibrosis-biomarker endpoints in adults with biopsy-confirmed MASH treated with fixed once-weekly subcutaneous pemvidutide (1.2 mg or 1.8 mg, without titration) vs placebo; the sponsor separately reported 48-week topline in December 2025. Phase 2 obesity data have also been reported by the sponsor. Common adverse events were dose-dependent gastrointestinal consistent with the GLP-1 / glucagon class.
Regulatory and posture
- Categories
- GLP-1, Fat Loss
- Aliases
- ALT-801, GLP-1 / glucagon dual receptor agonist
- Evidence posture
- human - Phase 2 IMPACT MASH data are published, with 48-week data in December 2025; the Phase 3 PERFORMA MASH trial is planned to begin in the second half of 2026 (FDA Breakthrough Therapy designation for MASH). Pemvidutide remains investigational.
- Regulatory status
- Investigational. Pemvidutide is a GLP-1 / glucagon dual receptor agonist developed by Altimmune with Phase 2 programs in MASH and obesity; a Phase 3 PERFORMA MASH trial is planned to begin in the second half of 2026. There is no FDA-approved drug label.
- Content review status
- investigational verified
Selected public sources
- Altimmune: pemvidutide IMPACT Phase 2b 48-week data and planned PERFORMA Phase 3 (MASH)
- ClinicalTrials.gov pemvidutide (ALT-801) trial search
- PubMed: Lancet 2025 - safety and efficacy of weekly pemvidutide versus placebo for MASH (IMPACT, Altimmune Phase 2) (PMID 41237796)
Related tools
- GLP-1 conversion calculator - Convert a GLP-1 mg dose to U-100 units and ml.
- GLP-1 ramp planner - Preview a linear educational dose-step table.
- Peptide half-life calculator - Estimate single-dose decay from cited half-life constants.
- PK simulator overview - Public overview of the Pro pharmacokinetic simulator.
- GLP-1 taper planner overview - Public overview of the Pro GLP-1 taper planner.
- Plateau analyzer overview - Public overview of the Pro plateau-pattern analyzer.
For research and educational purposes only. Not medical advice.