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Trial · Interventional

Active, not recruitingPhase 2Registry data

RESTORE TRIAL: Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)

NCTNCT07009860 (opens ClinicalTrials.gov in a new tab)Other idALT-801-241
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 2
Enrollment
121 participants (actual)
Sponsor
Altimmune, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
2 countries

United States, Puerto Rico

Start
16 Jun 2025
Primary completion
30 Sept 2027 (estimated)
Completion
30 Sept 2027 (estimated)
First posted
8 Jun 2025
Last update posted
17 Aug 2026
Conditions
Alcohol-associated Liver Disease

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2025202620272028
  1. Ph 2

    RESTORE TRIAL: Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)

    NCT07009860

    16 Jun 2025 to est. 30 Sept 2027

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD.

Interventions

  • PemvidutideDrug
  • PlaceboOther

Arms2

  • Active comparator

    Pemvidutide 2.4 mg

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Relative (%) reduction in liver stiffness by VCTE compared to baseline

    Time frame · Week 48 and 24

Secondary outcomes(2)

  1. Absolute reduction in liver stiffness by vibration controlled transient elastography (VCTE)

    Time frame · Week 48 and 24

  2. Absolute reduction in the Enhanced Liver Fibrosis (ELF) compared to baseline

    Time frame · Week 48 and 24

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: 1. Male or female ages 18 to 75 years, inclusive 2. Overweight or obesity, defined as BMI ≥ 25 kg/m2 3. 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 4. Evidence of recent alcohol use, defined as PEth level ≥ 35 ng/mL at screening 5. Liver stiffness of 10.0-24.9 kPa by VCTE, inclusive Exclusion Criteria: 1. Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization 2. History of hospitalization for alcohol withdrawal within the past year 3. History of seizures related to alcohol within the past year 4. History and/or current 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 5. Attempted suicide and/or serious suicidal intention or plan in the past 10 years

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