Evidence Grade D — Primarily preclinical. 12 published studies, mostly animal models. 7 registered clinical trials.
Medically reviewed by a licensed medical professional
Pemvidutide is a once-weekly injection in Phase II/III development by Altimmune that activates both GLP-1 and glucagon receptors in a balanced 1:1 ratio. It requires no dose titration — patients start on the full dose from day one — which simplifies treatment. Body composition analysis showed 78% of weight lost was fat, with muscle better preserved than with many competing treatments.
Pemvidutide is also known by these brand and alternate names:
12 published studies: 6 human, 0 animal, 0 in-vitro, 4 reviews
Pemvidutide is in Phase II/III development (not yet approved). In the MOMENTUM Phase II trial (391 patients, 48 weeks), the 2.4 mg dose achieved 15.6% weight loss. Body composition analysis showed 78% of weight lost was fat mass, with only 22% lean mass — a favourable ratio. A Phase IIb MASH trial (212 patients) showed MASH resolution in up to 75% of patients at the highest dose.
Pemvidutide's balanced receptor profile and no-titration dosing regimen represent potential practical advantages. The high rate of MASH resolution in Phase II positions it as a candidate for liver disease indications alongside obesity.
Pemvidutide maintains balanced 1:1 activity at both GLP-1 and glucagon receptors, unlike other dual agonists that are biased toward GLP-1. The balanced profile maximises the contribution of glucagon receptor activation to energy expenditure and liver fat metabolism. A proprietary extended-release technology provides controlled delivery from the injection site.
In the Phase II MOMENTUM trial (391 patients), the highest dose achieved 15.6% weight loss at 48 weeks. A separate Phase IIb MASH trial (212 patients) showed liver disease resolution in up to 75% of patients at the highest dose — one of the strongest MASH results reported, earning FDA Breakthrough Therapy Designation. A discrepancy exists between higher discontinuation rates in the obesity trial (16-20% at higher doses) and excellent tolerability in the MASH trial (less than 1% discontinuation), which is not yet explained. The favourable body composition profile and no-titration dosing are practical differentiators. Phase III for MASH is planned for 2026. Pemvidutide faces intense competition from larger pharmaceutical companies pursuing the same dual indications.
PeptideTrace tracks 7 registered clinical trials for Pemvidutide sourced from ClinicalTrials.gov.
RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
RECLAIM STUDY: A Phase 2 Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight
IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)
Extension of ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With (NAFLD)
ALT-801 in Diabetic and Non-Diabetic Overweight and Obese Subjects With Non-alcoholic Fatty Liver Disease (NAFLD)
Pemvidutide (ALT-801) is a balanced 1:1 GLP-1/glucagon dual receptor agonist peptide developed by Altimmune, utilizing proprietary EuPort half-life extension technology. CAS number: 2538014-94-5. The compound is administered as a once-weekly subcutaneous injection with no dose titration required at the 1.2 and 1.8 mg doses. Altimmune has received both FDA Fast Track and Breakthrough Therapy Designation for MASH, positioning pemvidutide as a potential dual-indication candidate for both obesity and liver disease.
Unlike other GLP-1/glucagon dual agonists that have differing ratios of receptor activity, pemvidutide maintains balanced 1:1 activity at both GLP-1R and GCGR. The EuPort domain provides extended half-life through controlled release from the injection site, potentially improving gastrointestinal tolerability by slowing the rate of bloodstream entry. The glucagon component directly promotes hepatic fat oxidation, reduces lipogenesis, and increases energy expenditure, while the GLP-1 component provides appetite suppression and glycemic control.
MOMENTUM Phase 2 (NCT05295875; N=391; 48 weeks): the 2.4 mg dose achieved -15.6% weight loss (32.2 lbs) versus -2.2% placebo. MRI body composition analysis (N=50) showed that only 21.9% of weight loss was lean mass with 78.1% being fat mass. IMPACT Phase 2b MASH trial (NCT05989711; N=212; Lancet 2025): MASH resolution without worsening fibrosis was achieved in 59.1% (1.2 mg) and 52.1% (1.8 mg) versus 19.1% placebo (P<0.0001). At 48 weeks, ELF score improvements of -0.49 to -0.58 versus +0.16 placebo (P<0.0001). Treatment discontinuation due to adverse events was less than 1% in the IMPACT trial.
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Semaglutide is one of the most extensively studied peptide medications available today, with clinical trial data spanning over 50,000 patients. It is sold as Ozempic for type 2 diabetes (approved 2017), Rybelsus as an oral tablet for diabetes (approved 2019), and Wegovy for weight management (approved 2021). Wegovy has since received additional approvals for reducing heart attack and stroke risk, for use in adolescents aged 12 and older, and for liver disease related to obesity. In clinical trials, patients taking Wegovy lost an average of 14.9% of their body weight over 68 weeks, and the SELECT trial demonstrated a 20% reduction in major cardiovascular events such as heart attack and stroke. Research is now exploring its potential in early Alzheimer's disease. The main side effects are gastrointestinal, particularly nausea, and a key limitation is that most weight tends to return after stopping treatment.
Bimagrumab is in Phase II/III development (not yet approved). A Phase II trial (75 patients with type 2 diabetes and obesity) showed 20.5% fat mass reduction with 3.6% lean mass increase — essentially reshaping body composition without net appetite suppression. The BELIEVE Phase IIb trial (507 patients) showed that bimagrumab plus semaglutide achieved 22% weight loss with the weight lost being 88% fat — significantly better body composition than semaglutide alone. Bimagrumab is not a peptide. Its strategic significance is as a combination partner to address the muscle loss problem inherent in weight loss with current obesity drugs. Eli Lilly's acquisition positions it alongside tirzepatide.
MariTide is in Phase II/III development (not yet approved). Phase II results (592 patients, 52 weeks) showed 16–20% weight loss across doses. Body composition analysis showed 26–37% fat mass reduction with 8–13% lean mass reduction. Notably, weight loss appeared to continue beyond the 52-week treatment period without plateau. MariTide's monthly dosing would be a significant convenience advantage if efficacy is confirmed in Phase III. The ongoing weight loss trajectory without plateau is particularly interesting and distinguishes it from some GLP-1 agonists where weight loss plateaus. Amgen is conducting Phase III trials.
Evidence Reviews
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