A study testing whether a new weekly shot from Altimmune, pemvidutide, can improve fatty liver disease.
What this means for you
- Who can join
- Adults 18 to 75, have alcohol-related liver disease, BMI 25+.
- What you take
- pemvidutide, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.
- How long it lasts
- The full study runs about 2.2 years; your own time in it is usually shorter.
- What you get
- The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.
What this study is for
Primary condition: Alcohol Liver Disease.
Full scientific study title: RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD).
Who can join
Adults 18 to 75, have alcohol-related liver disease, BMI 25+. A site coordinator confirms whether you qualify during a free screening visit. The exact medical requirements are below.
Full medical eligibility (for you and your doctor)verbatim from the registry
This is the exact wording from ClinicalTrials.gov, including clinical measures (lab values, imaging scores). Bring it to your doctor if any of it is unclear.
Key inclusion criteria
- Male or female ages 18 to 75 years, inclusive
- 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
Key exclusion criteria
- Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score >= 10 at screening and/or prior to randomization
- History of hospitalization for alcohol intoxication or alcohol withdrawal within the past year
- History of seizures related to alcohol within the past year
- 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 this study is enrolling
This trial has 42 sites across 17 states. Contact a site coordinator directly to start screening.
Arizona3 sites
- Altimmune Clinical Study SitePeoria, Arizona
- Altimmune Clinical Study SiteTucson, Arizona
- Altimmune Clinical Study SiteTuscon, Arizona
Arkansas1 site
- Altimmune Clinical Study SiteNorth Little Rock, Arkansas
California3 sites
- Altimmune Clinical Study SiteFresno, California
- Altimmune Clinical Study SiteLa Jolla, California
- Altimmune Clinical Study SitePasadena, California
Colorado1 site
- Altimmune Clinical Study SiteEnglewood, Colorado
Florida10 sites
- Altimmune Clinical Study SiteBradenton, Florida
- Altimmune Clinical Study SiteDoral, Florida
- Altimmune Clinical Study SiteDoral, Florida
- Altimmune Clinical Study SiteFort Myers, Florida
- Altimmune Clinical Study SiteMiami, Florida
- Altimmune Clinical Study SiteMiami, Florida
- Altimmune Clinical Study SiteMiami Lakes, Florida
- Altimmune Clinical Study SiteNaples, Florida
- Altimmune Clinical Study SiteOrlando, Florida
- Altimmune Clinical Study SitePort Orange, Florida
Georgia1 site
- Altimmune Clinical Study SiteAtlanta, Georgia
Indiana1 site
- Altimmune Clinical Study SiteIndianapolis, Indiana
Kentucky1 site
- Altimmune Clinical Study SiteLouisville, Kentucky
Louisiana3 sites
- Altimmune Clinical Study SiteBastrop, Louisiana
- Altimmune Clinical Study SiteMarrero, Louisiana
- Altimmune Clinical Study SiteWest Monroe, Louisiana
Missouri2 sites
- Altimmune Clinical Study SiteKansas City, Missouri
- Altimmune Clinical Study SiteSt Louis, Missouri
Nevada1 site
- Altimmune Clinical Study SiteLas Vegas, Nevada
New York3 sites
- Altimmune Clinical Study SiteManhasset, New York
- Altimmune Clinical Study SiteNew York, New York
- Altimmune Clinical Study SiteSyracuse, New York
North Carolina1 site
- Altimmune Clinical Study SiteWilmington, North Carolina
Ohio1 site
- Altimmune Clinical Study SiteWestlake, Ohio
Texas8 sites
- Altimmune Clinical Study SiteBrownsville, Texas
- Altimmune Clinical Study SiteDallas, Texas
- Altimmune Clinical Study SiteEdinburg, Texas
- Altimmune Clinical Study SiteHouston, Texas
- Altimmune Clinical Study SiteHouston, Texas
- Altimmune Clinical Study SiteSan Antonio, Texas
- Altimmune Clinical Study SiteSan Antonio, Texas
- Altimmune Clinical Study SiteWaco, Texas
Virginia1 site
- Altimmune Clinical Study SiteRichmond, Virginia
Washington1 site
- Altimmune Clinical Study SiteSeattle, Washington
Timeline
Started enrolling: 2025-06-16. Expected completion: 2027-08-31. Last updated on ClinicalTrials.gov: 2026-03-20.
Official source
We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:
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