Pemvidutide
Also known as: ALT-801, GLP-1/Glucagon dual receptor agonist (1:1 balanced), Altimmune GLP-1/GCGR agonist
Overview
Pemvidutide (ALT-801) is a once-weekly, balanced 1:1 GLP-1/glucagon dual receptor agonist developed by Altimmune, Inc. (Nasdaq: ALT), distinguished by its equal affinity for both GLP-1 and glucagon receptors — a design that maximizes direct hepatic fat oxidation effects alongside central appetite suppression. In Phase 2 obesity trials (MOMENTUM, 48 weeks), pemvidutide produced 15.6% weight loss at 2.4 mg with a landmark finding: only 21.9% of weight loss was lean mass (versus up to 40% for some GLP-1 comparators), representing class-leading lean mass preservation. Phase 2b IMPACT trial in MASH (biopsy-confirmed F2/F3 fibrosis) showed statistically significant improvements in non-invasive markers of fibrosis (ELF, LSM) at 48 weeks, and FDA End-of-Phase 2 meeting supports advancing to Phase 3 in MASH. FDA has granted Fast Track designation for pemvidutide in both MASH and alcohol use disorder (AUD). Phase 2 trials are also ongoing in AUD and alcohol-associated liver disease (ALD).
Mechanism of Action
Balanced 1:1 GLP-1/glucagon receptor agonism: GLP-1R activation suppresses appetite and enhances insulin secretion; GCGR activation directly drives hepatic fatty acid oxidation and thermogenesis. The equal receptor ratio maximizes direct liver effects while GLP-1 counterbalances glucagon's hyperglycemic potential. This mechanism explains superior MASH efficacy and class-leading lean mass preservation (only 21.9% of weight loss is lean tissue).
Potential Benefits
- Phase 2 MOMENTUM (obesity, 48 weeks): 15.6% weight loss at 2.4 mg
- Class-leading lean mass preservation: only 21.9% of weight loss from lean mass (vs. ~40% for GLP-1-only drugs)
- Phase 2b IMPACT (MASH, 48 weeks): statistically significant ELF and LSM reductions
- 75.2% relative reduction in liver fat at 24 weeks (1.8 mg dose)
- 84.6% of patients achieved ≥50% liver fat reduction at 24 weeks (1.8 mg)
- ALT reduction of 37.4 IU/L (IMPACT, 1.8 mg vs. -10.3 IU/L placebo)
- 7.5% weight loss in MASH patients at 48 weeks (1.8 mg, no plateau)
- FDA Fast Track designation for MASH and Alcohol Use Disorder
- End-of-Phase 2 FDA meeting: supports Phase 3 registration trial in F2/F3 MASH
- Blood pressure reductions and 'cardioprotective' lipid profile improvements
- Phase 2 initiated for AUD (RECLAIM) and ALD (RESTORE) — May/July 2025
Research Dosage Notes
The following reflects doses used in published research studies. This is not medical advice.
Consult published research literature for study-specific protocols.
Routes of Administration
Subcutaneous Injection High
Once-weekly SC injection; studied at doses of 1.2–2.4 mg. Peptide-based with fatty acid side chain for albumin binding and extended half-life. Standard abdominal/thigh injection sites.
Read our full Routes of Administration Guide for detailed comparison of all delivery methods.
Stacking Protocols
Popular research stacks involving Pemvidutide:
Metabolic Health Stack
Combines Pemvidutide with MOTS-c (mitochondrial metabolism) and AOD-9604 (lipolysis) for metabolic optimization.
Explore our complete Peptide Stacking Guide for more combinations and safety considerations.
Reconstitution
| Storage | Refrigerate at 2-8°C after reconstitution. Do not freeze reconstituted solution. |
|---|
Typical vial sizes: 5 mg. Add bac water slowly down the side of the vial, swirl gently — do not shake. Use insulin syringe for precise dosing.
Need exact syringe measurements?
Amino Acid Sequence
Proprietary Altimmune sequence; balanced 1:1 GLP-1/glucagon dual receptor agonist peptide with fatty acid conjugation for once-weekly dosing
Side Effects & Safety
- Nausea (GLP-1 class effect, dose-dependent)
- Vomiting (less frequent than GLP-1-only therapies)
- Diarrhea
- Decreased appetite
- Extremely low discontinuation rate due to adverse events: 0% at 1.2 mg, 1.2% at 1.8 mg vs. 3.5% placebo in IMPACT
- No severe or serious treatment-related adverse events in MASH trial
- No significant hypoglycemia (GLP-1 counterbalances glucagon's glycogenolytic effect)
- Injection site reactions (occasional)
- Favorable tolerability profile is a key clinical differentiator
Safety & Contraindications
This information is for educational purposes only. Consult a qualified healthcare provider before using any peptide.
MTC/MEN2
GLP-1 component carries standard thyroid C-cell tumor risk. Contraindicated in MTC/MEN2 patients.
Hepatic Impairment
Glucagon receptor agonism affects hepatic glucose output. Use caution in patients with severe hepatic impairment (Child-Pugh C).
Heart Rate Concerns
Glucagon component may increase heart rate. Monitor in patients with cardiovascular disease or arrhythmias.
Pregnancy & Lactation
Not studied in pregnancy. Avoid use.
Drug Interactions
- Insulin/sulfonylureas: Dual GLP-1/glucagon agonism affects glucose metabolism. Risk of hypoglycemia with insulin; risk of hyperglycemia without proper monitoring.
- Warfarin: Significant weight loss may alter warfarin pharmacokinetics. Monitor INR closely during treatment.
Pharmacokinetics
| Half-Life | ~7 days (once-weekly dosing; fatty acid conjugation for albumin binding) |
|---|---|
| Storage | Refrigerate at 2–8°C; do not freeze; protect from light |
Synergistic Compounds
The following compounds have been studied alongside Pemvidutide for potential complementary or synergistic effects:
Learn More
References & Further Reading
- Altimmune announces positive 48-week topline results from IMPACT Phase 2b MASH trial
- Effect of pemvidutide, a GLP-1/glucagon dual receptor agonist, on MASLD: A randomized, double-blind, placebo-controlled study
- Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease
- Safety and efficacy of weekly pemvidutide versus placebo (IMPACT Phase 2b)
- Pemvidutide preserves lean mass during weight loss (MOMENTUM Phase 2 analysis)
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