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NCT06987513·Phase 2·INTERVENTIONAL

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

PemvidutideWeight lossCompleted

Status

Completed

Phase

Phase 2

Enrollment

100

Locations

12

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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

Treatment arms and agents.

DRUG

Pemvidutide

Pemvidutide 2.4 mg SC once weekly

OTHER

Placebo

Placebo SC once weekly

Timeline

From registration to results.

  1. First posted

    May 23, 2025

  2. Study start

    May 15, 2025

  3. Primary completion

    Jul 30, 2026

  4. Study completion

    Jul 30, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Jul 31, 2026

Outcomes

What the study measures.

Primary outcomes

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

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

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

Time frame · Baseline to Week 24

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

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

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

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

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

Percent changes from baseline in body weight

Time frame · Baseline to Week 24

Percent change from baseline in BMI

Time frame · Baseline to Week 24

Percent change from baseline in waist circumference

Time frame · Baseline to Week 24

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

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 locations

12 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

Altimmune Clinical Study Site

Los Angeles, California, United States

Altimmune Clinical Study Site

Aurora, Colorado, United States

Altimmune Clinical Study Site

New Haven, Connecticut, United States

Altimmune Clinical Study Site

Fort Myers, Florida, United States

Altimmune Clinical Study Site

University Park, Florida, United States

Altimmune Clinical Study Site

North Canton, Ohio, United States

Altimmune Clinical Study Site

Tulsa, Oklahoma, United States

Altimmune Clinical Study Site

Philadelphia, Pennsylvania, United States

Altimmune Clinical Study Site

Providence, Rhode Island, United States

Altimmune Clinical Study Site

Charleston, South Carolina, United States

Altimmune Clinical Study Site

Charlottesville, Virginia, United States

Altimmune Clinical Study Site

Richmond, Virginia, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

ClinicalTrials.gov ↗Search PubMed ↗Search FDA ↗Search EMA ↗

Related trials

More studies on Pemvidutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.

TrialsPemvidutide trial dashboard →