DRUG
Pemvidutide
Pemvidutide 2.4 mg
RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
Status
Recruiting
Phase
Phase 2
Enrollment
100
Locations
43
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Interventions
Treatment arms and agents.
OTHER
Placebo
Subcutaneous injection
Timeline
From registration to results.
First posted
Jun 8, 2025
Study start
Jun 16, 2025
Primary completion
Mar 31, 2027
Study completion
Aug 31, 2027
Results posted
Not reported
Registry updated
Mar 20, 2026
Outcomes
What the study measures.
Primary outcomes
Relative (%) change in liver stiffness by VCTE compared to baseline at Week 24
Time frame · Week 24
Secondary outcomes
Relative (%) change in liver stiffness by VCTE compared to baseline at Week 48
Time frame · Week 24 and 48
Absolute change in the Enhanced Liver Fibrosis (ELF) score at Weeks 24 and 48 compared to baseline
Time frame · Week 24 and 48
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Sex
- ALL
- 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. 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
Study locations
43 registered sites.
Puerto Rico · United States. Showing up to 24 locations stored in the fast local snapshot.
Altimmune Clinical Study Site
Peoria, Arizona, United States
Altimmune Clinical Study Site
Tucson, Arizona, United States
Altimmune Clinical Study Site
Tuscon, Arizona, United States
Altimmune Clinical Study Site
North Little Rock, Arkansas, United States
Altimmune Clinical Study Site
Fresno, California, United States
Altimmune Clinical Study Site
La Jolla, California, United States
Altimmune Clinical Study Site
Pasadena, California, United States
Altimmune Clinical Study Site
Englewood, Colorado, United States
Altimmune Clinical Study Site
Bradenton, Florida, United States
Altimmune Clinical Study Site
Doral, Florida, United States
Altimmune Clinical Study Site
Doral, Florida, United States
Altimmune Clinical Study Site
Fort Myers, Florida, United States
Altimmune Clinical Study Site
Miami, Florida, United States
Altimmune Clinical Study Site
Miami, Florida, United States
Altimmune Clinical Study Site
Miami Lakes, Florida, United States
Altimmune Clinical Study Site
Naples, Florida, United States
Altimmune Clinical Study Site
Orlando, Florida, United States
Altimmune Clinical Study Site
Port Orange, Florida, United States
Altimmune Clinical Study Site
Atlanta, Georgia, United States
Altimmune Clinical Study Site
Indianapolis, Indiana, United States
Altimmune Clinical Study Site
Louisville, Kentucky, United States
Altimmune Clinical Study Site
Bastrop, Louisiana, United States
Altimmune Clinical Study Site
Marrero, Louisiana, United States
Altimmune Clinical Study Site
West Monroe, Louisiana, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Pemvidutide.
NCT IDStudyPhase / statusEnrollmentUpdated
RECLAIM STUDY: Phase 2 Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight
Altimmune, Inc. · Alcohol Use Disorder (AUD)
Phase 2
Completed
100
2026-07
IMPACT TRIAL: Efficacy and Safety of Pemvidutide in Subjects With Nonalcoholic Steatohepatitis (NASH)
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Phase 2
Completed
212
2026-05
ALT-801 (Pemvidutide) in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability
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Phase 1
Completed
100
2025-06
Pemvidutide (ALT-801) DDI Study in Healthy Volunteers
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Phase 1
Completed
40
2025-06
ALT-801 in Overweight and Obese Subjects With Type 2 Diabetes Mellitus (T2DM)
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Phase 1
Completed
55
2025-06
A Study of ALT-801 in Patients With Bacillus Calmette-Guerin (BCG) Failure Non-Muscle Invasive Bladder Cancer
Altor BioScience · Non-muscle Invasive Bladder Cancer
Phase 1 / Phase 2
Terminated
12
2024-07
A Study of ALT-801 in Combination With Cisplatin and Gemcitabine in Muscle Invasive or Metastatic Urothelial Cancer
Altor BioScience · Transitional Cell Carcinoma of Bladder · Urethra Cancer
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2024-06
QUILT-3.020: A Study of ALT-801 in Patients With Relapsed or Refractory Multiple Myeloma
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Phase 1 / Phase 2
Terminated
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2024-06
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