Pemvidutide for Alcoholic Liver Disease

Recruiting at 32 trial locations

Overseen By Julio Gutierrez, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Altimmune, Inc.

Disqualifiers: Alcohol withdrawal, Seizures, Schizophrenia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called pemvidutide to determine its effectiveness for people with alcoholic liver disease (ALD). Researchers aim to assess whether taking this treatment once a week is safe and improves liver health. Participants will receive either pemvidutide or a placebo (a non-active substance) for comparison. This trial may suit individuals who have struggled with alcohol use for the past three years and have been diagnosed with liver problems. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that pemvidutide has been tested for safety in various health conditions. In one study, participants with metabolic liver disease used pemvidutide for 24 weeks, and no serious safety issues emerged. Another study tested pemvidutide in individuals with liver disease related to metabolic problems and found the treatment generally well-tolerated, with no severe side effects reported. These findings suggest pemvidutide may be safe for humans, but further studies are needed to confirm this. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for alcoholic liver disease, which often focus on lifestyle changes and managing symptoms, Pemvidutide works by targeting and reducing liver inflammation directly. This is exciting because it uses a unique mechanism of action not commonly seen in current therapies, potentially offering a more direct approach to treating the disease. Researchers are particularly interested in Pemvidutide's ability to address the underlying causes of liver damage, which could lead to more effective long-term outcomes for patients.

What evidence suggests that pemvidutide might be an effective treatment for alcoholic liver disease?

Research has shown that pemvidutide, which participants in this trial may receive, can significantly reduce liver fat. In earlier studies, patients experienced a reduction in liver fat by up to 76.4%. Pemvidutide has also been linked to reduced liver inflammation and weight loss, both crucial for liver health. Early results suggest it might help reduce liver scarring, a major issue in liver diseases. This evidence indicates that pemvidutide could effectively treat conditions like alcoholic liver disease. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

The RESTORE trial is for individuals with Alcohol-Associated Liver Disease (ALD). Specific eligibility details are not provided, but typically participants would need to meet certain health standards and may be required to abstain from alcohol.

Inclusion Criteria

Overweight or obesity, defined as BMI ≥ 25 kg/m2

History of alcohol misuse for the prior 3 years, with an alcohol intake ≥ 50 grams per day for males and ≥ 40 grams per day for females on average in the past year

Liver stiffness of 10.0-18.5 kPa by VCTE, inclusive

Exclusion Criteria

History of hospitalization for alcohol intoxication or alcohol withdrawal within the past year

Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization

History and/or current DSM-5 diagnosis of schizophrenia, bipolar disorder, psychotic disorder, or another severe psychiatric disorder, unless documented as well-controlled by the Investigator for at least 6 months prior to screening and cleared by the Medical Monitor

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either pemvidutide 2.4 mg or placebo once weekly

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 This Phase 2 study tests the safety and effectiveness of Pemvidutide, given as a 2.4 mg subcutaneous injection once weekly, compared to a placebo in patients with ALD. The study randomly assigns participants to either the drug or placebo group without them knowing which one they're getting.

How Is the Trial Designed?

Group I: Pemvidutide 2.4 mg Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Altimmune, Inc.

Lead Sponsor

Trials

17

Recruited

1,500+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12529369/

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

2. ir.altimmune.com ir.altimmune.com/news-releases/news-release-details/altimmune-announces-fda-fast-track-designation-pemvidutide

Altimmune Announces FDA Fast Track Designation for ... Pemvidutide is the only drug currently granted Fast Track Designation in AUD. RECLAIM, a Phase 2 trial of pemvidutide in AUD, is currently ...

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

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 ...

4. checkorphan.org checkorphan.org/news/altimmune-ai-analysis-shows-pemvidutide-significantly-reduces-liver-fibrosis-in-mash-patients/

Pemvidutide Dramatically Reduces Liver Fibrosis in MASH ... Data for early fibrosis showed 34% of patients in the pemvidutide 1.8 mg group (n = 85), and 24% of patients in the pemvidutide 1.2 mg group (n ...

5. psychiatrictimes.com psychiatrictimes.com/view/fda-grants-fast-track-designation-to-pemvidutide-for-treatment-of-alcohol-use-disorder

FDA Grants Fast Track Designation to Pemvidutide for ... In a post-hoc AI-based analysis of the biopsies from the IMPACT trial, pemvidutide also achieved a statistically significant reduction in liver ...

6. empr.com empr.com/news/pemvidutide-fast-tracked-for-alcohol-use-disorder/

Pemvidutide Fast Tracked for Alcohol Use Disorder - MPR “Fatty liver develops in up to 90% of problem drinkers and places individuals with AUD at risk for alcohol-associated hepatitis. Treatment ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07009860?locStr=Puerto%20Rico&country=Puerto%20Rico&rank=6

RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy ... This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD.