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Active, not recruitingNCT07009860Updated Aug 17, 2026

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

A Phase 2 interventional study of Pemvidutide and Placebo in Alcohol-associated Liver Disease, sponsored by Altimmune, Inc.. Active, not recruiting at 37 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Altimmune, Inc. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
121
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Alcohol-associated Liver Disease
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
121 participants (actual)

Study arms

  • Active comparator
    Pemvidutide 2.4 mg

    Drug: Pemvidutide

  • Placebo comparator
    Placebo

    Other: Placebo

Interventions

  • DrugPemvidutide

    Pemvidutide 2.4 mg SC Injection

  • OtherPlacebo

    Placebo SC Injection

05

What researchers measure

Primary outcomes

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

    Time frame: Week 48 and 24

Secondary outcomes

  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

06

Study locations

37 sites
  • Altimmune Clinical Study Site
    Peoria, Arizona 85381, United States
  • Altimmune Clinical Study Site
    Tucson, Arizona 85712, United States
  • Altimmune Clinical Study Site
    North Little Rock, Arkansas 72117, United States
  • Altimmune Clinical Study Site
    Fresno, California 93720, United States
  • Altimmune Clinical Study Site
    La Jolla, California 92037, United States
  • Altimmune Clinical Study Site
    Pasadena, California 91105, United States
  • Altimmune Clinical Study Site
    Bradenton, Florida 34201, United States
  • Altimmune Clinical Study Site
    Doral, Florida 33122, United States
  • Altimmune Clinical Study Site
    Fort Myers, Florida 33192, United States
  • Altimmune Clinical Study Site
    Miami, Florida 33125, United States
  • Altimmune Clinical Study Site
    Miami, Florida 33165, United States
  • Altimmune Clinical Study Site
    Miami Lakes, Florida 33122, United States
  • Altimmune Clinical Study Site
    Naples, Florida 34102, United States
  • Altimmune Clinical Study Site
    Orlando, Florida 32803, United States
  • Altimmune Clinical Study Site
    Atlanta, Georgia 30309, United States
  • Altimmune Clinical Study Site
    Indianapolis, Indiana 46202, United States
  • Altimmune Clinical Study Site
    Louisville, Kentucky 40202, United States
  • Altimmune Clinical Study Site
    Bastrop, Louisiana 71220, United States
  • Altimmune Clinical Study Site
    Marrero, Louisiana 70072, United States
  • Altimmune Clinical Study Site
    West Monroe, Louisiana 71291, United States
  • Altimmune Clinical Study Site
    St Louis, Missouri 63123, United States
  • Altimmune Clinical Study Site
    Las Vegas, Nevada 89106, United States
  • Altimmune Clinical Study Site
    Manhasset, New York 11030, United States
  • Altimmune Clinical Study Site
    New York, New York 10032, United States
  • Altimmune Clinical Study Site
    Syracuse, New York 13210, United States
  • Altimmune Clinical Study Site
    Wilmington, North Carolina 28403, United States
  • Altimmune Clinical Study Site
    Westlake, Ohio 44145, United States
  • Altimmune Clinical Study Site
    Brownsville, Texas 78520, United States
  • Altimmune Clinical Study Site
    Dallas, Texas 75390, United States
  • Altimmune Clinical Study Site
    Edinburg, Texas 78539, United States
  • Altimmune Clinical Study Site
    Houston, Texas 77030, United States
  • Altimmune Clinical Study Site
    Houston, Texas 77079, United States
  • Altimmune Clinical Study Site
    San Antonio, Texas 78215, United States
  • Altimmune Clinical Study Site
    San Antonio, Texas 78251, United States
  • Altimmune Clinical Study Site
    Waco, Texas 76710, United States
  • Altimmune Clinical Study Site
    Seattle, Washington 98105, United States
  • Altimmune Clinical Study Site
    San Juan, 00927, Puerto Rico
07

References and documents

Individual participant data

Plan to share: Yes — It is anticipated that the results of this study will be presented at scientific meetings and/or published in a peer reviewed scientific or medical journal. A Publications Committee, comprised of the Investigators participating in the study and representatives from the Sponsor, as appropriate, will be formed to oversee the publication of the study results, which will reflect the experience of all participating study centers. Subsequently, individual Investigators may publish results from the study in compliance with their agreement with the Sponsor.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07009860
Lead sponsor
Altimmune, Inc.
Responsible party
Sponsor
First posted
Jun 8, 2025
Start date
Jun 16, 2025
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Aug 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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