Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Altimmune, Inc.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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. Evidence of recent alcohol use, defined as PEth level ≥ 35 ng/mL at screening
5. Liver stiffness of 10.0-24.9 kPa by VCTE, inclusive
You may not be if
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 withdrawal within the past year
3. History of seizures related to alcohol within the past year
4. History and/or current 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
5. Attempted suicide and/or serious suicidal intention or plan in the past 10 years
Clareo Health | RESTORE TRIAL: Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
