Alcohol Use Disorder (AUD)
Conditions
Keywords
Pemvidutide, GLP-1 receptor agonist, Alcohol Use Disorder, Obesity, Overweight, AUD treatment, Phase 2
Brief summary
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in the treatment of AUD in subjects with obesity or overweight. After signing the informed consent form, subjects will be screened and if eligible randomized 1:1 to 1 of the following 2 treatment arms: * Pemvidutide: 2.4 mg SC once weekly * Placebo: Placebo SC once weekly
Interventions
DRUGPemvidutide
Pemvidutide 2.4 mg SC once weekly
OTHERPlacebo
Placebo SC once weekly
Sponsors
Altimmune, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in the average number of heavy drinking days per week | Baseline to Weeks 21-24 | Change from baseline in the average number of heavy drinking days per week, with a heavy drinking day defined as 5 or more drinks in the day for men and 4 or more drinks in the day for women, using the Timeline Followback (TLFB) method |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects achieving a 2-level reduction in WHO risk drinking level | Baseline to Weeks 21-24 | Proportion of subjects achieving a 2-level reduction in WHO risk drinking level using the TLFB method for the 4-week period comprising Weeks 21 through 24 |
| Absolute change from baseline in average phosphatidylethanol (PEth) levels at Week 24 | Baseline to Week 24 | — |
| Change from baseline in average number of drinks per drinking day | Baseline to Weeks 21-24 | Change from baseline in average number of drinks per drinking day using the TLFB method for the 4-week period comprising Week 21 through 24 |
| Change from baseline in proportion of subjects achieving no heavy drinking days | Baseline to Weeks 21-24 | Change from baseline in proportion of subjects achieving no heavy drinking days using the TLFB method for the 4-week period comprising Week 21 through 24 |
| Change from baseline in average percent days completely abstinent | Baseline to Weeks 21-24 | Change from baseline in average percent days completely abstinent using the TLFB method for the 4-week period comprising Week 21 through 24 |
| Change from baseline at Week 24 in average Drinker Inventory of Consequences - Short Inventory of Problems (DrInc-SIP-2R) | Baseline to Week 24 | — |
| Change from baseline at Week 24 in Patient Reported Outcomes Measurement Information System (PROMIS) Negative Alcohol Consequences (NECO) Short Form | Baseline to Week 24 | — |
| Percent changes from baseline in body weight | Baseline to Week 24 | — |
| Percent change from baseline in BMI | Baseline to Week 24 | — |
| Percent change from baseline in waist circumference | Baseline to Week 24 | — |
Countries
United States
Outcome results
None listed