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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)
Lead sponsor
Asset
Pemvidutide
Subcutaneous · GLP-1 / glucagon dual
Listed sites
43
Recruiting sites
8
Enrollment
100
estimated
Study population
Alcohol / substance use, MASH / NAFLD / liver fibrosis, Obesity / overweight
Key I/E criterion
•BMI ≥25
Primary endpoint
•Liver stiffness (VCTE), change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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. Liver stiffness of 10.0-18.5 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 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
Endpoints (3)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
MASH / liver
3 endpointsRelative (%) change in liver stiffness by VCTE compared to baseline at Week 24
Time frame:Week 24
Liver stiffness (VCTE), change
percent change from baseline, improvement
Relative (%) change in liver stiffness by VCTE compared to baseline at Week 48
Time frame:Week 24 and 48
Liver stiffness (VCTE), change
percent change from baseline, improvement
Absolute change in the Enhanced Liver Fibrosis (ELF) score at Weeks 24 and 48 compared to baseline
Time frame:Week 24 and 48
ELF score, change
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.