Pemvidutide for Nonalcoholic Steatohepatitis (NASH)

(IMPACT Trial)

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

190 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing pemvidutide, a medication that may help treat NASH, a liver disease. It aims to see if the drug can reduce liver damage and help the liver heal.

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.

What data supports the effectiveness of the drug Pemvidutide for treating nonalcoholic steatohepatitis (NASH)?

Research on similar drugs like semaglutide shows promise in treating NASH by improving liver health. Additionally, studies on pemafibrate, another drug for liver conditions, have shown improvements in liver function and reduction in liver fat, suggesting potential benefits for Pemvidutide. ^{1 2 3 4 5}

What makes the drug Pemvidutide unique for treating NASH?

Pemvidutide is a novel treatment for NASH, a condition with no approved pharmacological options, making it a potentially groundbreaking therapy for this liver disease. ^{1 2 6 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Netherlands 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. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Semaglutide for the treatment of non-alcoholic steatohepatitis: Trial design and comparison of non-invasive biomarkers. [2021]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Treatment of nonalcoholic steatohepatitis with colestimide. [2020]

4. Poland pubmed.ncbi.nlm.nih.gov

Pemafibrate improves hepatic inflammation, function and fibrosis in patients with non-alcoholic fatty liver disease: a one-year observational study. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Pemafibrate Ameliorates Liver Dysfunction and Fatty Liver in Patients with Non-Alcoholic Fatty Liver Disease with Hypertriglyceridemia: A Retrospective Study with the Outcome after a Mid-Term Follow-Up. [2021]

6. England pubmed.ncbi.nlm.nih.gov

A novel HSF1 activator ameliorates non-alcoholic steatohepatitis by stimulating mitochondrial adaptive oxidation. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A Placebo-Controlled Trial of Subcutaneous Semaglutide in Nonalcoholic Steatohepatitis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Systematic review with network meta-analysis: comparative efficacy of pharmacologic therapies for fibrosis improvement and resolution of NASH. [2023]