Clinical trial NCT07009860: RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Alcohol Liver Disease
Lead sponsor: Altimmune, Inc.
Sponsor class: INDUSTRY
First posted: 2025-06-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Relative (%) change in liver stiffness by VCTE compared to baseline at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: Relative (%) change in liver stiffness by VCTE compared to baseline at Week 48
timeFrame: Week 24 and 48
measure: Absolute change in the Enhanced Liver Fibrosis (ELF) score at Weeks 24 and 48 compared to baseline
timeFrame: Week 24 and 48
Other outcomes:
Locations:
city: Peoria
country: United States
facility: Altimmune Clinical Study Site
state: Arizona
city: Tucson
country: United States
facility: Altimmune Clinical Study Site
state: Arizona
city: North Little Rock
country: United States
facility: Altimmune Clinical Study Site
state: Arkansas
city: Fresno
country: United States
facility: Altimmune Clinical Study Site
state: California
city: La Jolla
country: United States
facility: Altimmune Clinical Study Site
state: California
city: Pasadena
country: United States
facility: Altimmune Clinical Study Site
state: California
city: Englewood
country: United States
facility: Altimmune Clinical Study Site
state: Colorado
city: Bradenton
country: United States
facility: Altimmune Clinical Study Site
state: Florida
city: Doral
country: United States
facility: Altimmune Clinical Study Site
state: Florida
city: Fort Myers
country: United States
facility: Altimmune Clinical Study Site
state: Florida
city: Miami Lakes
country: United States
facility: Altimmune Clinical Study Site
state: Florida
city: Miami
country: United States
facility: Altimmune Clinical Study Site
state: Florida
city: Naples
country: United States
facility: Altimmune Clinical Study Site
state: Florida
city: Orlando
country: United States
facility: Altimmune Clinical Study Site
state: Florida
city: Port Orange
country: United States
facility: Altimmune Clinical Study Site
state: Florida
city: Atlanta
country: United States
facility: Altimmune Clinical Study Site
state: Georgia
city: Indianapolis
country: United States
facility: Altimmune Clinical Study Site
state: Indiana
city: Louisville
country: United States
facility: Altimmune Clinical Study Site
state: Kentucky
city: Bastrop
country: United States
facility: Altimmune Clinical Study Site
state: Louisiana
city: Marrero
country: United States
facility: Altimmune Clinical Study Site
state: Louisiana
city: Kansas City
country: United States
facility: Altimmune Clinical Study Site
state: Missouri
city: Las Vegas
country: United States
facility: Altimmune Clinical Study Site
state: Nevada
city: Manhasset
country: United States
facility: Altimmune Clinical Study Site
state: New York
city: Westlake
country: United States
facility: Altimmune Clinical Study Site
state: Ohio
city: Brownsville
country: United States
facility: Altimmune Clinical Study Site
state: Texas
city: Dallas
country: United States
facility: Altimmune Clinical Study Site
state: Texas
city: Edinburg
country: United States
facility: Altimmune Clinical Study Site
state: Texas
city: Houston
country: United States
facility: Altimmune Clinical Study Site
state: Texas
city: Houston
country: United States
facility: Altimmune Clinical Study Site
state: Texas
city: San Antonio
country: United States
facility: Altimmune Clinical Study Site
state: Texas
city: Waco
country: United States
facility: Altimmune Clinical Study Site
state: Texas
city: Richmond
country: United States
facility: Altimmune Clinical Study Site
state: Virginia
city: Seattle
country: United States
facility: Altimmune Clinical Study Site
state: Washington
city: San Juan
country: Puerto Rico
facility: Altimmune Clinical Study Site
Study officials:
References: