Pemvidutide for Alcoholism

Recruiting at 11 trial locations

Overseen By Shaheen Tomah, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Altimmune, Inc.

Disqualifiers: Schizophrenia, Bipolar, Psychotic, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for adults aged 18-75 with obesity or overweight who have moderate to severe Alcohol Use Disorder (AUD) according to DSM-5. They must drink heavily each week and consent in writing. People can't join if they have serious alcohol withdrawal, were hospitalized for alcohol issues, or have certain psychiatric disorders.

Inclusion Criteria

Overweight or obesity, defined as BMI ≥ 25 kg/m2

Written informed consent signed prior to performance of any study procedures

Diagnosis of current AUD of moderate or greater severity according to DSM-5 criteria

Exclusion Criteria

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

Presence of clinically significant alcohol withdrawal symptoms, as defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization

History of hospitalization for alcohol intoxication or alcohol withdrawal

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either pemvidutide 2.4 mg or placebo subcutaneously once weekly

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Pemvidutide

Trial Overview The study tests Pemvidutide's effectiveness and safety in treating AUD among those with obesity/overweight. Participants are randomly assigned to receive either Pemvidutide (2.4 mg once weekly) or a placebo via subcutaneous injection.

Participant Groups

Group I: Pemvidutide 2.4mg (Active) Experimental Treatment 1 Intervention

Subcutaneous injection

Group II: Placebo Placebo Group 2 Interventions

Subcutaneous injection

Who Is Running the Clinical Trial?

Altimmune, Inc.

Lead Sponsor

Trials

17

Recruited

1,500+