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Glucagon-like peptide-1 (GLP-1) receptor agonist

Pemvidutide for Nonalcoholic Steatohepatitis (NASH) (IMPACT Trial)

Phase 2

Recruiting

Research Sponsored by Altimmune, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks and 48 weeks

Awards & highlights

IMPACT Trial Summary

This trial will look at how well a drug helps treat fatty liver disease and fibrosis caused by it.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects of Pemvidutide are not detailed here but may include typical drug reactions such as nausea, headache, fatigue, injection site reactions, and possible impacts on blood sugar control in diabetics.

IMPACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks and 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks and 48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of subjects achieving NASH resolution (NAFLD activity score [NAS], ballooning = 0; lobular inflammation = 0, 1) with at least a 2-point reduction in NAS without worsening of fibrosis

Proportion of subjects achieving at least 1 stage improvement in liver fibrosis without worsening of NASH (defined as no change in the NAS, ie, the sum score for ballooning, inflammation, and steatosis)

Secondary outcome measures

Absolute change in Enhanced Liver Fibrosis (ELF) score

Absolute change in Fibroscan-AST (FAST) score

Absolute change in MRI-based corrected T1 (cT1) imaging

+10 more

IMPACT Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Pemvidutide 1.8 mg (n=76)Experimental Treatment1 Intervention

Group II: Pemvidutide 1.2 mg (n=38)Experimental Treatment1 Intervention

Group III: Placebo (n=76)Placebo Group1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Altimmune, Inc.Lead Sponsor

16 Previous Clinical Trials

1,348 Total Patients Enrolled

4 Trials studying Non-alcoholic Fatty Liver Disease

299 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

Pemvidutide (Glucagon-like peptide-1 (GLP-1) receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05989711 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any criteria for selection into this research project?

"Candidates aged between 18 and 75, who suffer from non-alcoholic fatty liver disease, can apply to take part in this trial. 190 participants are needed for the study's completion."

Answered by AI

How many individuals are being welcomed into this research endeavor?

"Affirmative. The information hosted on clinicaltrials.gov establishes that this investigation, which was initially posted on July 27th 2023, is actively recruiting participants. Approximately 190 patients have to be enlisted from 2 different research centres."

Answered by AI

Are adolescents being considered as participants for this clinical research?

"The requirements for this trial necessitate that participants are between 18 and 75. Although, there is a separate clinical trial dedicated to patients under the age of 18 with 17 enrolment slots and another one catering towards those over 65 years old which has 220 openings."

Answered by AI

Is participation in this experiment open to volunteers at the moment?

"Affirmative, the information available from clinicaltrials.gov affirms that this research trial is still recruiting participants. The initial posting occurred on July 27th 2023 and was recently updated August 10th of the same year. Currently, 190 individuals are needed to be recruited from 2 sites."

Answered by AI

What do the safety studies indicate regarding Pemvidutide 1.2 mg in individuals?

"The safety profile of Pemvidutide 1.2 mg (n=38) is rated as a 2, indicating that while there is some clinical evidence supporting its security, none exists to validate efficacy at this time due to the nature of being a Phase 2 trial."

Answered by AI

Who else is applying?

What site did they apply to?

Altimmune Clinical Study Site

What portion of applicants met pre-screening criteria?

Did not meet criteria

Why did patients apply to this trial?

I have only been given water pills since I was diagnosed 11 years ago. Just been diagnosed with Stage 3 NASH and was told this was the last step to reverse this disease before Fibrosis.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (IMPACT Trial)

2023. "Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH) (IMPACT Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05989711.

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