Clinical trial NCT06987513: 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
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Alcohol Use Disorder (AUD)
Keywords: Pemvidutide
GLP-1 receptor agonist
Alcohol Use Disorder
Obesity
Overweight
AUD treatment
Phase 2
Lead sponsor: Altimmune, Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: 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 TLFB method
timeFrame: Week 24
Secondary outcomes:
measure: 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.
timeFrame: Week 24
measure: Absolute change from baseline in average phosphatidylethanol (PEth) levels at Week 24
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Altimmune Clinical Study Site
state: California
city: Aurora
country: United States
facility: Altimmune Clinical Study Site
state: Colorado
city: New Haven
country: United States
facility: Altimmune Clinical Study Site
state: Connecticut
city: Fort Myers
country: United States
facility: Altimmune Clinical Study Site
state: Florida
city: University Park
country: United States
facility: Altimmune Clinical Study Site
state: Florida
city: North Canton
country: United States
facility: Altimmune Clinical Study Site
state: Ohio
city: Tulsa
country: United States
facility: Altimmune Clinical Study Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Altimmune Clinical Study Site
state: Pennsylvania
city: Providence
country: United States
facility: Altimmune Clinical Study Site
state: Rhode Island
city: Charleston
country: United States
facility: Altimmune Clinical Study Site
state: South Carolina
city: Charlottesville
country: United States
facility: Altimmune Clinical Study Site
state: Virginia
city: Richmond
country: United States
facility: Altimmune Clinical Study Site
state: Virginia
Study officials:
References: