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HomeTrials › NCT06987513

Other · Phase 2 · Active, not recruiting

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

NCT06987513 · Sponsor: Altimmune, Inc.

What this trial means for you

This study is active, not recruiting — it is not currently taking new participants, but its results may matter for treatments you're considering. It's studying Pemvidutide for alcohol use disorder (aud).

Who can joinAll sexes, 18 Years – 75 Years
Healthy volunteersNo — diagnosis required
What you'd takePemvidutide
Study length~12 months overall
Planned participants100
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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

Study sites by state

California

  • Altimmune Clinical Study Site — Los Angeles

Colorado

  • Altimmune Clinical Study Site — Aurora

Connecticut

  • Altimmune Clinical Study Site — New Haven

Florida

  • Altimmune Clinical Study Site — Fort Myers
  • Altimmune Clinical Study Site — University Park

Ohio

  • Altimmune Clinical Study Site — North Canton

Oklahoma

  • Altimmune Clinical Study Site — Tulsa

Pennsylvania

  • Altimmune Clinical Study Site — Philadelphia

Rhode Island

  • Altimmune Clinical Study Site — Providence

South Carolina

  • Altimmune Clinical Study Site — Charleston

Virginia

  • Altimmune Clinical Study Site — Charlottesville
  • Altimmune Clinical Study Site — Richmond

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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