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Trial · Interventional

CompletedPhase 2Registry data

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

Overview

Status
Completed
Phase
Phase 2
Enrollment
100 participants (actual)
Sponsor
Altimmune, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
15 May 2025
Primary completion
30 Jul 2026
Completion
30 Jul 2026
First posted
23 May 2025
Last update posted
31 Jul 2026
Conditions
Alcohol Use Disorder (AUD)

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph 2

    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

    NCT06987513

    15 May 2025 to 30 Jul 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • PemvidutideDrug
  • PlaceboOther

Arms2

  • Experimental

    Pemvidutide 2.4 mg

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Baseline to Weeks 21-24

    Registry description

    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(10)
  1. Proportion of subjects achieving a 2-level reduction in WHO risk drinking level

    Time frame · Baseline to Weeks 21-24

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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