NCT07009860 · Altimmune, Inc.
RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
What this study is about
This is a Phase 2, conducted at multiple hospitals, randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment study to evaluate the effectiveness and safety of pemvidutide in subjects with ALD. * Pemvidutide: 2.
View original scientific description
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD. * Pemvidutide: 2.
Interventions
DRUG
Pemvidutide
Pemvidutide 2.4 mg
OTHER
Placebo
Subcutaneous injection
Primary outcome measures
Relative (%) change in liver stiffness by VCTE compared to baseline at Week 24
Time frame: Week 24
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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. Liver stiffness of 10.0-18.5 kPa by VCTE, inclusive
Exclusion criteria
- 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 intoxication or alcohol withdrawal within the past year 3. History of seizures related to alcohol within the past year 4. 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
Where
- Peoria, Arizona
- Tucson, Arizona
- Tuscon, Arizona
- North Little Rock, Arkansas
- Fresno, California
- La Jolla, California
- Pasadena, California
- Englewood, Colorado
- Bradenton, Florida
- Doral, Florida
- Fort Myers, Florida
- Miami, Florida
And 26 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 20, 2026 · Source of record for eligibility and locations