Pemvidutide for Alcoholism

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called pemvidutide, a potential drug for individuals with Alcohol Use Disorder (AUD) who are also overweight or obese. Researchers aim to determine if this treatment can safely reduce alcohol consumption and its effects. Participants will receive either the active drug or a placebo once a week. Suitable candidates for this trial have been diagnosed with AUD, consume a high amount of alcohol weekly, and are overweight. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that pemvidutide is likely to be safe for humans?

Research shows that pemvidutide is under investigation for its safety and effectiveness in treating alcohol use disorder (AUD) in individuals who are overweight or have obesity. Earlier studies have shown that pemvidutide may help reduce alcohol consumption. Although detailed safety data from these studies is not provided, the trial's progression to the second phase of clinical testing is reassuring. By this stage, the treatment has already been tested in smaller groups to ensure reasonable safety.

Additionally, the FDA has granted pemvidutide Fast Track Designation for AUD. This designation indicates that early results are promising enough to expedite its development and review, suggesting potential benefits that may outweigh risks based on early data.

The trial is designed to closely monitor any side effects and ensure participant safety. Participants will receive either pemvidutide or a placebo, and doctors will track their progress and any unwanted side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholism?

Most treatments for alcoholism focus on behavioral therapy and medications like naltrexone, acamprosate, and disulfiram that alter brain chemistry or create adverse reactions to alcohol. But pemvidutide works differently, targeting metabolic pathways to potentially reduce alcohol cravings. Researchers are excited about pemvidutide because it is a GLP-1/glucagon receptor dual agonist, which has shown promise in weight management and may offer a novel approach to addressing alcoholism by altering how the body processes alcohol. This unique mechanism sets pemvidutide apart from typical medications that focus solely on the brain's reward system.

What evidence suggests that pemvidutide might be an effective treatment for alcoholism?

Research shows that pemvidutide, which participants in this trial may receive, might help treat Alcohol Use Disorder (AUD) in individuals who are overweight or obese. The FDA has granted it Fast Track Designation, allowing for expedited testing to address an unmet medical need. Early evidence suggests pemvidutide could work by controlling hunger and metabolism, potentially reducing alcohol consumption by influencing related behaviors. Detailed results from a 24-week study will soon provide a clearer understanding of its effectiveness. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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

Written informed consent signed prior to performance of any study procedures

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06987513

NCT06987513 | RECLAIM STUDY: A Phase 2 Evaluating ... 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.

2. ir.altimmune.com ir.altimmune.com/news-releases/news-release-details/altimmune-announces-fda-fast-track-designation-pemvidutide

Altimmune Announces FDA Fast Track Designation for ... Pemvidutide is the only drug currently granted Fast Track Designation in AUD. RECLAIM, a Phase 2 trial of pemvidutide in AUD, is currently ...

3. biospace.com biospace.com/press-releases/altimmune-announces-early-completion-of-enrollment-in-reclaim-phase-2-trial-evaluating-pemvidutide-in-alcohol-use-disorder

Altimmune Announces Early Completion of Enrollment in ... AUD can also lead to serious health consequences, including liver cirrhosis, cardiovascular disease, and cancer. Additionally, many patients ...

4. quiverquant.com quiverquant.com/news/Altimmune%2C+Inc.+to+Present+24-Week+Efficacy+Data+for+Pemvidutide+at+The+Liver+Meeting%C2%AE+2025

Altimmune, Inc. to Present 24-Week Efficacy Data for ... Altimmune will present 24-week efficacy and safety data from its pemvidutide trial at The Liver Meeting® 2025.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07009860?locStr=Puerto%20Rico&country=Puerto%20Rico&rank=6

RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy ... This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD.

6. psychiatryadvisor.com psychiatryadvisor.com/news/pemvidutide-fast-tracked-for-alcohol-use-disorder/

Pemvidutide Fast Tracked for Alcohol Use Disorder “In a preclinical model of free-choice alcohol use, pemvidutide was shown to produce rapid and significant reduction in alcohol intake,” said ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT07009860

Study Details | NCT07009860 | RESTORE TRIAL: A Phase ... This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD.