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

What Was Tested

In this phase 2 trial, researchers set out to test Pemvidutide.

It had two arms (groups): one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug and other.

Who Took Part

The registry lists 100 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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. Overweight or obesity, defined as BMI ≥ 25 kg/m2.

The full record lists 5 inclusion and 5 exclusion criteria; among the exclusions: history of hospitalization for alcohol intoxication or alcohol withdrawal; history of alcohol-related disorders including seizures related to alcohol, malloryweiss syndrome, and alcoholic ketoacidosis; 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.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Pemvidutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Pemvidutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-05-15 with completion listed for 2026-07-30.

It ran at 12 sites in United States (12).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change from baseline in the average number of heavy drinking days per week (time frame: Baseline to Weeks 21-24).

It also tracked 10 secondary outcomes, for example Absolute change from baseline in average phosphatidylethanol (PEth) levels at Week 24, Change from baseline in average number of drinks per drinking day, Change from baseline in proportion of subjects achieving no heavy drinking days, Change from baseline in average percent days completely abstinent, Change from baseline at Week 24 in average Drinker Inventory of Consequences - Short Inventory of Problems (DrInc-SIP-2R) and Percent changes from baseline in body weight.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Pemvidutide in 100 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Pemvidutide compound page, all human trials.