Pemvidutide for Nonalcoholic Steatohepatitis (NASH)

(IMPACT Trial)

Not currently recruiting at 38 trial locations

Overseen By Altimmune CTM

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Altimmune, Inc.

Disqualifiers: Type 1 diabetes, Cirrhosis, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new treatment, pemvidutide, can improve conditions for individuals with Nonalcoholic Steatohepatitis (NASH). The study will test various doses of pemvidutide and compare them to a placebo, which contains no active ingredients. It seeks participants diagnosed with NASH through a liver biopsy and who also have Type 2 diabetes or meet specific criteria for metabolic syndrome, a group of conditions that increase heart disease risk. This trial is not suitable for those with recent significant weight changes or other chronic liver diseases. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, if you have Type 2 diabetes, you should be on a stable treatment regimen for at least 90 days before screening.

Is there any evidence suggesting that pemvidutide is likely to be safe for humans?

Research has shown that pemvidutide was well-tolerated in earlier studies. Participants in these studies experienced significant reductions in liver fat and body weight after 24 weeks of treatment, suggesting the treatment has generally been safe for humans.

Pemvidutide affects two specific areas in the body, GLP-1 and glucagon, which help control blood sugar and metabolism. Although still under study, earlier trials have not identified any major safety issues. It is important to note that this treatment remains in the early testing stages for NASH, a liver disease.

The data so far appears promising for its safety. However, more research is needed to fully understand any possible side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for NASH?

Pemvidutide is unique because it targets NASH by mimicking the effects of natural hormones that regulate appetite and metabolism, specifically GLP-1 and glucagon receptors. Unlike standard treatments like vitamin E, pioglitazone, or lifestyle changes, which focus on improving liver health indirectly, Pemvidutide directly influences metabolic pathways to reduce liver fat. Researchers are excited about its potential to offer a more targeted and efficient approach to treating NASH, with the promise of addressing the root cause of the disease rather than just managing symptoms.

What evidence suggests that pemvidutide might be an effective treatment for NASH?

Research has shown that pemvidutide can help treat Nonalcoholic Steatohepatitis (NASH). In earlier studies, patients who took pemvidutide experienced a noticeable drop in liver fat, a major issue in NASH. These patients also lost a significant amount of weight, which can further improve liver health. Pemvidutide targets specific areas of the body to lower liver fat and reduce inflammation. In this trial, participants will receive either pemvidutide at a dose of 1.2 mg or 1.8 mg, or a placebo. Overall, evidence suggests that pemvidutide may help resolve NASH and improve liver scarring. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Adults aged 18-75 with moderate to severe NASH (stages 2-3 fibrosis) can join this trial. They must have a confirmed diagnosis, certain levels of liver fat and inflammation, and meet criteria for Metabolic Syndrome. Those with Type 1 diabetes, recent significant weight changes, or very high liver enzymes cannot participate.

Inclusion Criteria

A histologic NAFLD Activity Score (NAS) ≥ 4 with a score of at least 1 on each subcomponent score based on central pathology evaluation (steatosis [0-3], lobular inflammation [0-3], and hepatocyte ballooning [0-2])

I agree to undergo a liver biopsy if needed.

Written informed consent

Exclusion Criteria

Weight gain or loss > 5% in the 3 months prior to randomization or > 10% in the 6 months prior to screening

ALT or AST laboratory values > 5 × ULN

My blood sugar levels are very high or my HbA1c is above 9.5%.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either pemvidutide or placebo to evaluate efficacy and safety in NASH

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pemvidutide

Trial Overview The IMPACT Trial is testing Pemvidutide's effectiveness on resolving NASH without worsening fibrosis compared to a placebo. Participants will be randomly assigned to receive either the drug or placebo and will undergo liver biopsies before and after treatment.

How Is the Trial Designed?

Group I: Pemvidutide 1.8 mg (n=76) Experimental Treatment 1 Intervention

Group II: Pemvidutide 1.2 mg (n=38) Experimental Treatment 1 Intervention

Group III: Placebo (n=76) Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Altimmune, Inc.

Lead Sponsor

Trials

17

Recruited

1,500+

Published Research Related to This Trial

In a systematic review of 8 studies involving 2413 patients, 24 weeks of semaglutide treatment significantly reduced liver enzymes (alanine transaminase and aspartate transaminase) and improved liver fat content and stiffness, indicating its efficacy in treating non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH).

Despite its benefits, semaglutide treatment was associated with a higher risk of serious gastrointestinal adverse events, such as nausea and vomiting, highlighting the need for careful monitoring of side effects during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of semaglutide in the treatment of nonalcoholic fatty liver disease or non-alcoholic steatohepatitis: A systematic review and meta-analysis. Bandyopadhyay, S., Das, S., Samajdar, SS., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05989711

Study Details | NCT05989711 | IMPACT TRIAL: Efficacy ... A Phase 2, multi-center, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in NASH.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2589555925001612

Safety and efficacy of 24 weeks of pemvidutide in ... 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39002641/

Effect of pemvidutide, a GLP-1/glucagon dual receptor ... In patients with MASLD, weekly pemvidutide treatment yielded significant reductions in LFC, markers of hepatic inflammation, and body weight compared to ...

4. ir.altimmune.com ir.altimmune.com/news-releases/news-release-details/altimmune-announces-initiation-phase-2b-impact-trial-evaluating

Altimmune Announces Initiation of Phase 2b IMPACT Trial ... The key efficacy endpoints are NASH resolution and fibrosis improvement at 24 weeks of treatment, with subjects followed for an additional 24 ...

5. journal-of-hepatology.eu journal-of-hepatology.eu/article/S0168-8278(24)02362-6/fulltext

Effect of pemvidutide, a GLP-1/glucagon dual receptor ... Pemvidutide is a GLP-1/glucagon dual receptor agonist. Pemvidutide treatment significantly reduced liver fat content compared to placebo.

6. altimmune.com altimmune.com/pemvidutide/

Pemvidutide Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of four indications: obesity, ...