Actively Recruiting
RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
Led by Altimmune, Inc. · Updated on 2026-03-20
100
Participants Needed
43
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 Participate
Eligibility Criteria
You may qualify if you...
- Male or female ages 18 to 75 years, inclusive
- Overweight or obesity, defined as BMI 25 25 kg/m2
- History of alcohol misuse for the prior 3 years, with an alcohol intake 25 50 grams per day for males and 25 40 grams per day for females on average in the past year
- Liver stiffness of 10.0-18.5 kPa by VCTE, inclusive
You will not qualify if you...
- Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score 25 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 43 locations
1
Altimmune Clinical Study Site
Peoria, Arizona, United States, 85381
Not Yet Recruiting
2
Altimmune Clinical Study Site
Tucson, Arizona, United States, 85712
Not Yet Recruiting
3
Altimmune Clinical Study Site
Tuscon, Arizona, United States, 85712
Not Yet Recruiting
4
Altimmune Clinical Study Site
North Little Rock, Arkansas, United States, 72117
Actively Recruiting
5
Altimmune Clinical Study Site
Fresno, California, United States, 93720
Not Yet Recruiting
6
Altimmune Clinical Study Site
La Jolla, California, United States, 92037
Not Yet Recruiting
7
Altimmune Clinical Study Site
Pasadena, California, United States, 91105
Not Yet Recruiting
8
Altimmune Clinical Study Site
Englewood, Colorado, United States, 80113
Not Yet Recruiting
9
Altimmune Clinical Study Site
Bradenton, Florida, United States, 34201
Not Yet Recruiting
10
Altimmune Clinical Study Site
Doral, Florida, United States, 33122
Not Yet Recruiting
11
Altimmune Clinical Study Site
Doral, Florida, United States, 33122
Actively Recruiting
12
Altimmune Clinical Study Site
Fort Myers, Florida, United States, 33192
Not Yet Recruiting
13
Altimmune Clinical Study Site
Miami, Florida, United States, 33125
Actively Recruiting
14
Altimmune Clinical Study Site
Miami, Florida, United States, 33165
Not Yet Recruiting
15
Altimmune Clinical Study Site
Miami Lakes, Florida, United States, 33122
Not Yet Recruiting
16
Altimmune Clinical Study Site
Naples, Florida, United States, 34102
Not Yet Recruiting
17
Altimmune Clinical Study Site
Orlando, Florida, United States, 32803
Not Yet Recruiting
18
Altimmune Clinical Study Site
Port Orange, Florida, United States, 32127
Not Yet Recruiting
19
Altimmune Clinical Study Site
Atlanta, Georgia, United States, 30309
Not Yet Recruiting
20
Altimmune Clinical Study Site
Indianapolis, Indiana, United States, 46202
Not Yet Recruiting
21
Altimmune Clinical Study Site
Louisville, Kentucky, United States, 40202
Not Yet Recruiting
22
Altimmune Clinical Study Site
Bastrop, Louisiana, United States, 71220
Not Yet Recruiting
23
Altimmune Clinical Study Site
Marrero, Louisiana, United States, 70072
Not Yet Recruiting
24
Altimmune Clinical Study Site
West Monroe, Louisiana, United States, 71291
Not Yet Recruiting
25
Altimmune Clinical Study Site
Kansas City, Missouri, United States, 64131
Not Yet Recruiting
26
Altimmune Clinical Study Site
St Louis, Missouri, United States, 63123
Actively Recruiting
27
Altimmune Clinical Study Site
Las Vegas, Nevada, United States, 89106
Not Yet Recruiting
28
Altimmune Clinical Study Site
Manhasset, New York, United States, 11030
Not Yet Recruiting
29
Altimmune Clinical Study Site
New York, New York, United States, 10032
Actively Recruiting
30
Altimmune Clinical Study Site
Syracuse, New York, United States, 13210
Actively Recruiting
31
Altimmune Clinical Study Site
Wilmington, North Carolina, United States, 28403
Not Yet Recruiting
32
Altimmune Clinical Study Site
Westlake, Ohio, United States, 44145
Not Yet Recruiting
33
Altimmune Clinical Study Site
Brownsville, Texas, United States, 78520
Not Yet Recruiting
34
Altimmune Clinical Study Site
Dallas, Texas, United States, 75390
Not Yet Recruiting
35
Altimmune Clinical Study Site
Edinburg, Texas, United States, 78539
Not Yet Recruiting
36
Altimmune Clinical Study Site
Houston, Texas, United States, 77030
Not Yet Recruiting
37
Altimmune Clinical Study Site
Houston, Texas, United States, 77079
Not Yet Recruiting
38
Altimmune Clinical Study Site
San Antonio, Texas, United States, 78215
Actively Recruiting
39
Altimmune Clinical Study Site
San Antonio, Texas, United States, 78251
Actively Recruiting
40
Altimmune Clinical Study Site
Waco, Texas, United States, 76710
Not Yet Recruiting
41
Altimmune Clinical Study Site
Richmond, Virginia, United States, 23249
Not Yet Recruiting
42
Altimmune Clinical Study Site
Seattle, Washington, United States, 98105
Not Yet Recruiting
43
Altimmune Clinical Study Site
San Juan, Puerto Rico, Puerto Rico, 00927
Not Yet Recruiting
Research Team
Y
Yadira Ulrey, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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