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Completed

NCT Number: NCT06987513

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

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

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Key information

Conditions

Alcohol Use Disorder (AUD) Alcohol-Related Disorders Alcoholism Body Weight Chemically-Induced Disorders Mental Disorders Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Altimmune Clinical Study Site, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent signed prior to performance of any study procedures
  • Male or female ages 18 to 75 years, inclusive
  • Diagnosis of current AUD of moderate or greater severity according to DSM-5 criteria
  • 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
  • Overweight or obesity, defined as BMI ≥ 25 kg/m2

Exclusion criteria

  • 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
  • History of alcohol-related disorders including seizures related to alcohol, MalloryWeiss Syndrome, and alcoholic ketoacidosis
  • 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
  • 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

Treatment and study plan

Pemvidutide

Drug

Pemvidutide 2.4 mg SC once weekly

Placebo

Other

Placebo SC once weekly

Primary outcomes

  1. Change from baseline in the average number of heavy drinking days per week

    Time frame: 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 outcomes

  1. Proportion of subjects achieving a 2-level reduction in WHO risk drinking level

    Time frame: 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

  2. Absolute change from baseline in average phosphatidylethanol (PEth) levels at Week 24

    Time frame: Baseline to Week 24

  3. Change from baseline in average number of drinks per drinking day

    Time frame: 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

  4. Change from baseline in proportion of subjects achieving no heavy drinking days

    Time frame: 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

  5. Change from baseline in average percent days completely abstinent

    Time frame: 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

  6. Change from baseline at Week 24 in average Drinker Inventory of Consequences - Short Inventory of Problems (DrInc-SIP-2R)

    Time frame: Baseline to Week 24

  7. Change from baseline at Week 24 in Patient Reported Outcomes Measurement Information System (PROMIS) Negative Alcohol Consequences (NECO) Short Form

    Time frame: Baseline to Week 24

  8. Percent changes from baseline in body weight

    Time frame: Baseline to Week 24

  9. Percent change from baseline in BMI

    Time frame: Baseline to Week 24

  10. Percent change from baseline in waist circumference

    Time frame: Baseline to Week 24

Sponsors and collaborators

Lead sponsor

Altimmune, Inc.

Industry

Registry information

Official study title

RECLAIM STUDY: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol Use Disorder (AUD) in Subjects With Obesity or Overweight

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 23, 2025
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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