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Tests treatment safety and results for Alcohol Liver Disease
Official title RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
ClinicalTrials.gov ID: NCT07009860
What this study is testing
What is Pemvidutide?
Pemvidutide is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for alcohol liver disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's 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
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- Liver stiffness of 10.0-18.5 kPa by VCTE, inclusive
You likely can't join 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...
The study team makes the final eligibility decision.
Where it's taking place
- Peoria, Arizona, United States
- Tucson, Arizona, United States
- Tuscon, Arizona, United States
- North Little Rock, Arkansas, United States
- Fresno, California, United States
- La Jolla, California, United States
- Pasadena, California, United States
- Englewood, Colorado, United States
- Bradenton, Florida, United States
- Doral, Florida, United States
- Fort Myers, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Naples, Florida, United States
- Orlando, Florida, United States
- Port Orange, Florida, United States
- Atlanta, Georgia, United States
- Indianapolis, Indiana, United States
- Louisville, Kentucky, United States
- Bastrop, Louisiana, United States
+ 19 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Peoria, Arizona, United States; Tucson, Arizona, United States; Tuscon, Arizona, United States; North Little Rock, Arkansas, United States; Fresno, California, United States; La Jolla, California, United States and 33 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.