Evaluating Pemvidutide for Alcohol Use Disorder in Overweight Patients
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight
This study is testing if a new medication called pemvidutide can help overweight people with Alcohol Use Disorder drink less and improve their health.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Altimmune, Inc. Industry-sponsored |
| Locations | 12 sites (Los Angeles, California and 11 other locations) |
| Trial ID | NCT06987513 on ClinicalTrials.gov |
What this trial studies
This Phase 2 clinical trial is designed to assess the efficacy and safety of pemvidutide, a GLP-1 receptor agonist, in treating Alcohol Use Disorder (AUD) among individuals who are overweight or obese. Participants will be randomly assigned to receive either pemvidutide or a placebo, administered via subcutaneous injection once weekly. The study aims to determine if pemvidutide can effectively reduce alcohol consumption and improve overall health outcomes in this population. The trial will involve multiple clinical sites to ensure a diverse participant pool.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 75 with a diagnosis of moderate to severe Alcohol Use Disorder and a BMI of 25 kg/m2 or higher.
Not a fit: Patients with clinically significant alcohol withdrawal symptoms or a history of severe alcohol-related disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for individuals struggling with Alcohol Use Disorder who also face challenges related to obesity or being overweight.
How similar studies have performed: While the use of GLP-1 receptor agonists for AUD is a novel approach, other studies have explored similar mechanisms with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Written informed consent signed prior to performance of any study procedures 2. Male or female ages 18 to 75 years, inclusive 3. Diagnosis of current AUD of moderate or greater severity according to DSM-5 criteria 4. Reported drinking at least 28 drinks per week if male or 21 drinks per week if female in the 28 days prior to signing the informed consent. This should include at least 3 heavy drinking days per week (defined as ≥ 5 drinks per day for men and ≥ 4 drinks per day for women) Note: Baseline heavy drinking days will be determined by the TFLB method (28-day recall) drinking pattern collected at the initial screening visit 5. Overweight or obesity, defined as BMI ≥ 25 kg/m2 Exclusion Criteria: 1. Presence of clinically significant alcohol withdrawal symptoms, as defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization 2. History of hospitalization for alcohol intoxication or alcohol withdrawal 3. History of alcohol-related disorders including seizures related to alcohol, MalloryWeiss Syndrome, and alcoholic ketoacidosis 4. History and/or current DSM-5 diagnosis of schizophrenia, bipolar disorder, psychotic disorder or other severe psychiatric disorders, unless documented as well-controlled by the Investigator and cleared by the Medical Monitor 5. C-SSRS score indicative of active suicidal thoughts (answering "yes" to any of Questions 2 through 5 on the C-SSRS) in the past 6 months
Where this trial is running
Los Angeles, California and 11 other locations
- Altimmune Clinical Study Site — Los Angeles, California, United States (Recruiting)
- Altimmune Clinical Study Site — Aurora, Colorado, United States (Recruiting)
- Altimmune Clinical Study Site — New Haven, Connecticut, United States (Recruiting)
- Altimmune Clinical Study Site — Fort Myers, Florida, United States (Recruiting)
- Altimmune Clinical Study Site — University Park, Florida, United States (Recruiting)
- Altimmune Clinical Study Site — North Canton, Ohio, United States (Recruiting)
- Altimmune Clinical Study Site — Tulsa, Oklahoma, United States (Recruiting)
- Altimmune Clinical Study Site — Philadelphia, Pennsylvania, United States (Recruiting)
- Altimmune Clinical Study Site — Providence, Rhode Island, United States (Recruiting)
- Altimmune Clinical Study Site — Charleston, South Carolina, United States (Recruiting)
- Altimmune Clinical Study Site — Charlottesville, Virginia, United States (Recruiting)
- Altimmune Clinical Study Site — Richmond, Virginia, United States (Recruiting)
Study contacts
- Study coordinator: Shaheen Tomah, MD
- Email: information@altimmune.com
- Phone: 240-654-1450
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.