RESTORE TRIAL: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD.
* Pemvidutide: 2.4 mg SC once weekly
* Placebo: Placebo SC once weekly

Start Date16 Jun 2025

Sponsor / Collaborator

Altimmune, Inc.

NCT06987513

/ Active, not recruitingPhase 2

RECLAIM STUDY: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in the treatment of AUD in subjects with obesity or overweight. After signing the informed consent form, subjects will be screened and if eligible randomized 1:1 to 1 of the following 2 treatment arms:
* Pemvidutide: 2.4 mg SC once weekly
* Placebo: Placebo SC once weekly

Start Date15 May 2025

Sponsor / Collaborator

Altimmune, Inc.

NCT05989711

/ Active, not recruitingPhase 2

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in Non-Cirrhotic Subjects With Nonalcoholic Steatohepatitis (NASH)

Purpose of this study is to assess the effects of pemvidutide on NASH resolution and NASH fibrosis.

Start Date27 Jul 2023

Sponsor / Collaborator

Altimmune, Inc.

100 Clinical Results associated with Pemvidutide

100 Translational Medicine associated with Pemvidutide

100 Patents (Medical) associated with Pemvidutide

Literatures (Medical) associated with Pemvidutide

01 Nov 2025·JHEP Reports

Safety and efficacy of 24 weeks of pemvidutide in metabolic dysfunction-associated steatotic liver disease: A randomized, controlled clinical trial

Article

Author: Browne, Sarah K ; Suschak, John J ; Roberts, M Scot ; Gutierrez, Julio A ; Georges, Bertrand ; Harris, M Scott ; Yang, Jay ; Tomah, Shaheen

Background & Aims:

This was a double-blind 12-week extension of a randomized, placebo-controlled, 12-week trial of pemvidutide, a glucagon-like peptide-1/glucagon dual receptor agonist, in individuals with metabolic dysfunction-associated steatotic liver disease (MASLD).

Methods:

Completers of a double-blind trial of pemvidutide in MASLD, who were previously randomized 1:1:1:1 to pemvidutide at 1.2 mg, 1.8 mg, or 2.4 mg, or placebo administered subcutaneously once weekly for 12 weeks, were offered an additional 12 weeks of treatment at their originally assigned dose for a total of 24 weeks of treatment. Participants were stratified by the presence or absence of type 2 diabetes mellitus (T2DM). The primary efficacy endpoint was relative reduction (%) from baseline in liver fat content by magnetic resonance imaging-proton density fat fraction after 24 weeks of treatment.

Results:

There were 64 participants in the extension trial. Baseline mean values for BMI and liver fat content were 36.7 kg/m² and 22.2%; 26.6% of participants had T2DM. After 24 weeks of treatment, pemvidutide achieved relative reductions in liver fat content from baseline of 56.3%, 75.2%, and 76.4% for the pemvidutide 1.2 mg, 1.8 mg, and 2.4 mg groups respectively, vs. 14.0% for placebo (p <0.001 vs. placebo, all treatment groups), with 84.6% of participants achieving 50% reductions in liver fat content and 53.8% achieving normalization (≤5% liver fat content) at the 1.8 mg dose. Body weight was also reduced by 6.2% (p <0.001 vs. placebo) over 24 weeks of treatment. Pemvidutide was well-tolerated at all doses, with low incidences of side effects.

Conclusions:

In individuals with MASLD, 24 weeks of pemvidutide treatment resulted in significant reductions in liver fat content and body weight that further improved upon the effects observed at 12 weeks.

Impact and implications:

Overweight and obesity are strongly associated with metabolic dysfunction-associated steatotic liver disease and metabolic dysfunction-associated steatohepatitis (MASH), as the excess liver fat associated with obesity is a known driver of these conditions. Glucagon-like peptide-1 receptor (GLP-1R) agonists elicit weight loss through centrally and peripherally mediated effects on appetite, whereas G-coupled glucagon receptor (GCGR) agonists act directly on the liver to stimulate fatty acid oxidation and inhibit lipogenesis, providing a more potent mechanism for reducing liver fat content than weight loss alone. We previously showed that once-weekly treatment with pemvidutide, a dual GLP-1R/GCGR agonist, significantly reduced liver fat content, hepatic inflammatory activity, and body weight over 12 weeks. The current trial demonstrates that continued treatment with pemvidutide further improves these clinical markers of MASH.

Clinical Trials Registration:

The study is registered at ClinicalTrials.gov (NCT05292911).

01 May 2025·PEPTIDES

Multifunctional incretin peptides in therapies for type 2 diabetes, obesity and associated co-morbidities

Review

Author: Flatt, Peter R ; Conlon, J Michael ; Bailey, Clifford J

Recent studies with peptide-based incretin therapies have focussed mainly on the glucagon-like peptide-1 (GLP-1) receptor agonist semaglutide and the dual agonist tirzepatide that engages receptors for GLP-1 and glucose-dependent insulinotropic polypeptide (GIP). Randomised clinical trials and 'real-world' studies have confirmed the marked glucose-lowering and weight-lowering efficacy of these agents across diverse populations. These include different ethnic groups, young and elderly individuals with and without diabetes and/or overweight or obesity. Recent studies have also confirmed protections against the development and progression of cardiovascular and renal diseases that are additive to the benefits conferred by improved control of blood glucose and body weight. Emerging evidence suggests that incretin therapies could additionally ameliorate fatty liver disease, chronic inflammation, sleep apnea and possibly degenerative bone disorders and cognitive decline. New incretin-based peptide therapies in development include a long-acting glucagon receptor agonist (LY3324954), dual GLP-1/glucagon receptor agonists (survodutide, pemvidutide, mazdutide, G49), triple GLP-1/GIP/glucagon receptor agonists (retatrutide, efocipegtrutide), a combination of semaglutide with the amylin analogue cagrilintide (CagriSema), a unimolecular GLP-1/amylin receptor dual agonist (amycretin), and a GIP receptor antibody with GLP-1 receptor agonism (MariTide). The creation of multi-targeting incretin-based synthetic peptides provides opportunities for improved management of type 2 diabetes and obesity as well as new therapeutic approaches to an expanding list of associated co-morbidities. The aim of the review is to acquaint the reader with developments in the field from 2023 to the present (February 2025).

01 Feb 2025·Polski merkuriusz lekarski : organ Polskiego Towarzystwa Lekarskiego

Current priorities in research on metabolic-associated fatty liver disease based on the results of EASL – 2024

Review

Author: Khaitovych, Mykola V. ; Pinsky, Leonid L. ; Ryzhova, Irina P. ; Golubovska, Olga A.

Aim: To systematize and comprehensively analyze scientific sources and studies on metabolic-associated steatotic liver disease (MASLD) based on materials from the European Congress of the European Association for the Study of the Liver (EASL – 2024). Materials and Methods: This paper analyzes the current scientific research on the prevalence, pathogenesis, diagnostic methods, prognosis, and pharmacotherapy of MASLD presented at the EASL 2024 Congress. The following methods were used in the preparation of the work: a systematic approach and bibliosemantic analysis. Conclusions: Studies on the pathogenesis of MASLD progression confirm the significant role of insulin resistance and hyperinsulinemia in increasing hepatocyte cytolysis activity, raising the concentration of cytokeratin CK-18, HbA1c, low-density lipoproteins, triglycerides, and the severity of fibrosis (FIB-4). EASL 2024 studies evaluated the diagnostic efficiency of non-invasive methods for assessing steatosis and liver fibrosis severity in MASLD (FIB-4, FibroScan®, Enhanced Liver Fibrosis (ELF), Vibration Controlled Transient Elastography (VCTE), LiverPRO, etc.). Due to the high prevalence of steatotic liver disease, comorbidities such as chronic viral hepatitis C, autoimmune hepatitis, and alcoholic liver disease – contributing to liver fibrosis progression and hepatocellular carcinoma – are significant. Promising drugs for MASLD treatment include resmethyrom, fibroblast growth factor 21 analogs (including pegosafermin), and pemvidutide, a long-acting, balanced GLP-1/glucagon dual receptor agonist.

142

News (Medical) associated with Pemvidutide

19 Dec 2025

·www.fiercebiotech.com

Altimmune eyes phase 3 MASH trial as weight loss deepens

Altimmune is preparing for talks with the FDA about a phase 3 trial it plans to start next year.\n Altimmune has shared an update on the metabolic dysfunction-associated steatohepatitis (MASH) study that sank its stock in June. The 48-week readout linked the top dose of the GLP-1/glucagon dual receptor agonist to continued weight loss and improvements on noninvasive measures of liver fibrosis.Maryland-based Altimmune published 24-week data from the phase 2 trial in June. Pemvidutide failed to beat placebo on an endpoint that tracked patients who had improved fibrosis without worsening MASH, contributing to a steep drop in Altimmune’s share price. With no biopsies taken at Week 48, Altimmune is reliant on noninvasive measures of fibrosis to try to change the narrative around pemvidutide.Between the two readouts, enhanced liver fibrosis (ELF) scores on the high dose improved from -0.5 to -0.58. However, patients on the lower dose gave up some of their earlier gains, with ELF scores changing from -0.6 at Week 24 to -0.49 at Week 48. Both doses were significantly better than placebo at Week 48.Altimmune also shared liver stiffness measurement (LSM) data, reporting mean reductions from baseline of 3.04 and 3.97, respectively, on the low and high doses. Mazen Noureddin, M.D., principal investigator for the study, said in a statement that the ELF and LSM results are particularly compelling because the noninvasive markers have been shown to correlate with histologic fibrosis stage. “These results reinforce that pemvidutide may address both liver-specific and metabolic drivers of MASH without compromising tolerability—three critical elements of a potential effective treatment for this patient population,” Noureddin said. Noureddin added that he is encouraged by the dose response, which was evident in the weight loss data. Patients on the low dose largely maintained the weight lost by Week 24, with the figure falling from 5% to 4.5% over the following 24 weeks. But people on the high dose continued to shed the pounds, with weight loss increasing from 6.2% to 7.5% between the two readouts and yet to plateau. Yet, in other areas, even the high dose gave up some of the earlier gains. The reduction in liver fat content was lower at both doses at Week 48 than at Week 24. After 24 weeks, Altimmune saw reductions of 58% and 62.8%, respectively, on the low and high doses. The figures after 48 weeks were 45.2% for the low dose and 54.7% on the high dose. Safety and tolerability remained a bright spot in the Week 48 data. Adverse events leading to treatment discontinuation occurred in 0% and 1.2%, respectively, of patients on the low and high doses, compared to 3.5% of their peers on placebo. Shares in Altimmune slipped slightly, after initially rising, in premarket trading as investors digested the data. While investors appear to have doubts, Altimmune is projecting confidence as it prepares for talks with the FDA about a phase 3 trial it plans to start next year.The biotech highlighted the FDA’s recent qualification of a MASH artificial intelligence tool as a positive for its phase 3 program. Altimmune plans to integrate the tool into the trial to help standardize histologic assessment and reduce the time and resources needed for MASH drug development. The biotech ended September with $211 million.

Clinical ResultPhase 2Phase 3

19 Dec 2025

·endpoints.news

Altimmune advances in MASH; New China obesity biotech; Ipsen Phase 2 fail

Plus, news on: EpimAb, Boehringer and Nxera, Syneron, Amphix Altimmune goes to Phase 3 in MASH: The drug developer’s Phase 2 trial of pemvidutide, a GLP-1/glucagon agonist, failed in June. But based on a longer-term readout from that study, Altimmune is taking it to Phase 3 . In the new cut of data, the high dose of the drug appeared to help on several measures of liver health. Altimmune said it had held a “productive” meeting with the FDA about the data and was aligned with the regulator on plans for a registrational Phase 3 trial, which will start next year. — Elizabeth Cairns 🇨🇳 Beijing biotech’s nearly $100M financing: Syneron Bio almost clinched a megaround via Series A and A+ fundraises from AstraZeneca, Pfizer, GL Ventures and others. The startup forged an up to $3.4 billion biobuck pact with AstraZeneca earlier this year and is working on macrocyclic peptides, which have become a buzzy modality for their potential to combine the best of small molecules and biologics. — Kyle LaHucik 🇭🇰 EpimAb again files for HKEX listing: The biotech is trying for an IPO on the Hong Kong Stock Exchange after letting its summer attempt lapse. EpimAb is partnered with T cell engager startup Candid Therapeutics . — Kyle LaHucik 🇨🇳 A new obesity biotech in China: Rezubio will get into Phase 2 in obesity and diabetes with a $20 million Series A from Lapam Capital, Frees Fund and Riverhead Capital. The biotech is working on “membrane-anchored therapeutics.” It’s led by former Merck scientists, including CEO Yusheng Xiong. — Kyle LaHucik 🦴 Ipsen drug fails Phase 2 rare disease trial: The company was testing a program called fidrisertib in fibrodysplasia ossificans progressiva (FOP), a genetic disorder where muscles and connective tissue gradually and irreversibly turn into bone . On average, patients are diagnosed at 5 years old, Ipsen says. Fidrisertib missed the study’s primary endpoint of reducing new “heterotopic ossification” compared to placebo. Ipsen has closed the 113-patient study. — Max Gelman 💊 Boehringer Ingelheim drops Nxera’s schizophrenia drug: Tokyo-based Nxera will regain the full rights to the clinical-stage NXE0048149 (NXE’149) after the German drug giant decided not to license the GPR52 agonist. The March 2024 deal had come with €25 million ($29 million) upfront and up to €670 million ($780 million) in biobucks. Now, Nxera said it will look for a new pharma partner on the asset. Nxera recently laid off employees and has made obesity a focus of its pipeline going forward. — Kyle LaHucik 💰 Chicago biotech collects $12.5M: Northwestern University spinout Amphix Bio marked the initial closing of its seed round from undisclosed investors. The startup is working on peptide therapeutics for neurological injuries, neurodegenerative diseases and musculoskeletal disorders. Its lead candidate, AMFX-200, has FDA orphan drug status for treating acute spinal cord injury. It also has a drug-device combination for degenerative disc disease. — Kyle LaHucik

Orphan DrugPhase 2

19 Dec 2025

·firstwordpharma.com

Altimmune touts new data for MASH hopeful, but investors sour

Altimmune said Friday that its experimental drug pemvidutide continued to improve key non-invasive markers of fibrosis through 48 weeks in a mid-stage trial of patients with metabolic dysfunction-associated steatohepatitis (MASH), extending signals first seen at six months and clearing the way for Phase III testing next year.The Phase IIb IMPACT trial randomised 212 patients with biopsy-confirmed MASH and fibrosis stages F2/F3 with and without diabetes to receive either a 1.2 mg or 1.8 mg weekly subcutaneous dose of pemvidutide, or placeboAt the 24-week mark, the dual GLP-1/glucagon receptor agonist met one of the co-primary endpoints, achieving statistically significant rates of MASH resolution without worsening fibrosis versus placebo, but fell short on the other measure of fibrosis improvement without worsening of MASH. Those results, reported in June, put a serious dent in the company's stock.Investors still waryAnd it appears investors were not quite persuaded this time around either: after jumping in premarket trading on Friday, Altimmune shares were down more than 25% shortly after markets opened.The new 48-week data showed that patients on pemvidutide achieved significant improvements versus placebo in Enhanced Liver Fibrosis (ELF) scores and Liver Stiffness Measurement (LSM), with continued reductions from the 24-week timepoint. Specifically, mean ELF scores fell by 0.49 and 0.58 in the 1.2-mg and 1.8-mg arms, respectively, compared with a rise of 0.16 for placebo, while LSM declined by up to 3.97 kPa with pemvidutide. Additionally, roughly a third of patients on the higher dose achieved both a ≥0.5 reduction in ELF and a 30% drop in liver stiffness, versus just over 3% for placebo.Altimmune also reported significant improvements on other measures of liver health and hepatic inflammation, including reductions in liver fat content, ALT and corrected T1, alongside additional weight loss. Patients on the 1.8-mg dose lost 7.5% of body weight at 48 weeks, extending an earlier decline of 6.2% seen in the June readout, with "no evidence of plateauing," the company said.Safety remained consistent with earlier data, with treatment-related discontinuations of 0% and 1.2% in the low- and high-dose groups, compared to 3.5% for placebo, and no treatment-related serious adverse events.Hope for Phase IIIThe company said it recently completed a "productive" end-of-Phase II meeting with the FDA and aligned on parameters for a registrational Phase III trial in MASH patients with moderate-to-advanced fibrosis that it plans to start in 2026. Moreover, it said regulators were also receptive to its proposal to incorporate AIM-MASH AI Assist, a newly qualified AI tool intended to standardise histologic assessment to help reduce time and resources needed for MASH drug development.Despite the negative investor reaction following the June readout, some analysts are optimistic about the drug's prospects. In a note last month, Citizens JMP suggested pemvidutide's fibrosis response "was one of the best we have seen," given it was measured only after 24 weeks, while the placebo response was "one of the highest" they had seen. "The fibrotic effect was cooperated by multiple non-invasive fibrosis markers and AI pathology, and we fully expect pemvidutide to hit on fibrosis in a larger, longer Phase III. We also note both [Madrigal Pharmaceuticals'] Rezdiffra (resmetirom) and [Novo Nordisk's] Wegovy (semaglutide) missed statistically on fibrosis in their Phase II trials before hitting in Phase III."

Phase 2Clinical ResultPhase 3

100 Deals associated with Pemvidutide

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metabolic Dysfunction Associated Steatohepatitis	Phase 3	United States	Altimmune, Inc.	-
Obesity	Phase 3	United States	Altimmune, Inc.	-
Liver Diseases, Alcoholic	Phase 2	United States	Altimmune, Inc.	16 Jun 2025
Alcohol Use Disorder	Phase 2	United States	Altimmune, Inc.	15 May 2025
Diabetes Mellitus, Type 2	Phase 1	United States	Altimmune, Inc.	30 Sep 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05989711 (IMPACT, Pubmed \| Lancet)	Phase 2	Metabolic Dysfunction Associated Steatohepatitis	212	Pemvidutide 1.2 mg	enqbildhcj(sijqsonogv) = ansmxlbasd nsqicfelhy (ipkzqtemlc ) View more	Positive	01 Dec 2025
				Pemvidutide 1.8 mg	enqbildhcj(sijqsonogv) = cgxrxfbhwi nsqicfelhy (ipkzqtemlc ) View more
NCT05292911 (Pubmed \| JHEP Rep)	Phase 3	Metabolic dysfunction-associated steatotic liver disease	64	Pemvidutide 1.2 mg	gzlbpfrwsy(btbjrtyvhe): P-Value = <0.001 View more	Positive	01 Nov 2025
				Pemvidutide 1.8 mg
NCT05989711 (IMPACT, Company_Website \| NEWS) Manual	Phase 2	Metabolic dysfunction-associated steatotic liver disease	212	Pemvidutide 1.2 mgPemvidutide 1.2 mg	teyfkycoxg(fxnhopvxrm) = hyqbgpqhqq umgmvyaoiy (uijhtnzcqu ) Met View more	Positive	26 Jun 2025
				Pemvidutide 1.8 mgPemvidutide 1.8 mg	teyfkycoxg(fxnhopvxrm) = qkgszznlvx umgmvyaoiy (uijhtnzcqu ) Met View more
NCT05292911 (GlobeNewswire) Manual	Phase 2	Obesity	67	Pemvidutide	fltwrfymmf(xsrizfgvpc) = qtebictsbg hhvnzoccwq (wcdcwyxvis ) View more	Positive	10 Sep 2024
NCT01625260 (CTgov)	Phase 1/2	Non-Muscle Invasive Bladder Neoplasms	12	Gemcitabine+ALT-801 (0.06 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine)	wqollkfqwv = votakvmbuc msfufjhsts (lagbehvdqa, ncssvoipvc - zngiunaeru) View more	-	19 Jul 2024
				Gemcitabine+ALT-801 (0.08 mg/kg ALT-801 With 1000 mg/m^2 Gemcitabine)	wqollkfqwv = dgpesihxlx msfufjhsts (lagbehvdqa, fgmrewmvcx - pygkiqawxc) View more
NCT05006885 (Pubmed \| J Hepatol) Manual	Phase 1	Metabolic dysfunction-associated steatotic liver disease type 2 diabetes mellitus (T2DM)	94	Pemvidutide 1.2 mg	vovvejusbm(abddyxefms) = pisspxzotg qsxsvmlqjk (yvxtkwcqwr, -63.7 to -29.6)	Positive	01 Jul 2024
				Pemvidutide 1.8 mg	vovvejusbm(abddyxefms) = fhbbsjzoay qsxsvmlqjk (yvxtkwcqwr, -84.4 to -52.5) View more
NCT05295875 (MOMENTUM, GlobeNewswire) Manual	Phase 2	Obesity	391	Pemvidutide 1.2 mgPemvidutide 1.2 mg	lyqrizioqj(mtjqincvdl) = sysflxzqzy mkrincahda (wrmbptwudd )	Positive	23 Jun 2024
				Pemvidutide 1.8 mgPemvidutide 1.8 mg	lyqrizioqj(mtjqincvdl) = rsoehcaeox mkrincahda (wrmbptwudd )
ADA2024	Not Applicable	Overweight \| Obesity	-	Pemvidutide 1.2 mg	nxprdcymbz(vqvpclgihe) = Most adverse events were mild to moderate with only 1 drug-related SAE; glycemic control (glucose, HbA1c) was maintained with minimal increases in heart rate qutwulnbmy (azxkbqfhqe )	-	23 Jun 2024
				Pemvidutide 1.8 mg
NCT05295875 (MOMENTUM, NEWS) Manual	Phase 2	Overweight \| Obesity	391	pemvidutide 1.2mg	slzltukopq(oxbeztqunj) = mifmfmlztr eonwbdqrfa (vfeqcnfndp, 1.4) View more	Positive	02 Dec 2023
				pemvidutide 1.8mg	slzltukopq(oxbeztqunj) = iygbvftcxr eonwbdqrfa (vfeqcnfndp, 1.4) View more
NCT05292911 (Corporate Publications) Manual	Phase 1	Metabolic dysfunction-associated steatotic liver disease	64	Pemvidutide 1.2mg	ychfrzbqny(nzenrfknxy) = tehwzhshyy bcyoukfubx (eyvyzlyypt ) View more	Positive	13 Nov 2023
				Pemvidutide 1.8mg	ychfrzbqny(nzenrfknxy) = lmplgbniwa bcyoukfubx (eyvyzlyypt ) View more

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