RECLAIM STUDY: A Phase 2 Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight

Altimmune

Status and phase: Active, not recruiting; Phase 2

Conditions: Alcohol Use Disorder (AUD)

Treatments: Other: Placebo; Drug: Pemvidutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06987513

ALT-801-231

Details and patient eligibility

About

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

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Pemvidutide 2.4mg (Active)

Experimental group

Description:

Subcutaneous injection

Treatment:

Drug: Pemvidutide

Placebo

Placebo Comparator group

Description:

Subcutaneous injection

Treatment:

Other: Placebo