RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
RESTORE TRIAL: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
1 other identifier
interventional
100
2 countries
43
Brief 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.
- Pemvidutide: 2.4 mg SC once weekly
- Placebo: Placebo SC once weekly
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2025
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 5, 2025
CompletedFirst Posted
Study publicly available on registry
June 8, 2025
CompletedStudy Start
First participant enrolled
June 16, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2027
March 20, 2026
March 1, 2026
1.8 years
June 5, 2025
March 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Relative (%) change in liver stiffness by VCTE compared to baseline at Week 24
Week 24
Secondary Outcomes (2)
Relative (%) change in liver stiffness by VCTE compared to baseline at Week 48
Week 24 and 48
Absolute change in the Enhanced Liver Fibrosis (ELF) score at Weeks 24 and 48 compared to baseline
Week 24 and 48
Study Arms (2)
Pemvidutide 2.4 mg
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Altimmune, Inc.lead
Study Sites (43)
Altimmune Clinical Study Site
Peoria, Arizona, 85381, United States
Altimmune Clinical Study Site
Tucson, Arizona, 85712, United States
Altimmune Clinical Study Site
Tuscon, 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
Englewood, Colorado, 80113, United States
Altimmune Clinical Study Site
Bradenton, Florida, 34201, United States
Altimmune Clinical Study Site
Doral, Florida, 33122, 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
Port Orange, Florida, 32127, 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
Kansas City, Missouri, 64131, 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
Richmond, Virginia, 23249, United States
Altimmune Clinical Study Site
Seattle, Washington, 98105, United States
Altimmune Clinical Study Site
San Juan, Puerto Rico, 00927, Puerto Rico
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 5, 2025
First Posted
June 8, 2025
Study Start
June 16, 2025
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
August 31, 2027
Last Updated
March 20, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
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.