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New drug shows promise in cutting heavy drinking days

NCT ID NCT06987513

Disease control Sponsor: Altimmune, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 1 time

Summary

This study tests a weekly injection called pemvidutide to see if it can reduce heavy drinking in adults with alcohol use disorder who are also overweight or obese. About 100 participants will receive either the drug or a placebo for 24 weeks. The main goal is to measure the change in the number of heavy drinking days per week.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

100 people

The number who actually took part.

Started

May 2025

Finished

Jul 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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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Conditions

The condition(s) this trial relates to.

alcohol abuse Obesity Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alcohol use disorder (AUD)

Contacts and locations

Locations

  • Altimmune Clinical Study Site

    Aurora, Colorado, 80045, United States

  • Altimmune Clinical Study Site

    New Haven, Connecticut, 06511, United States

  • Altimmune Clinical Study Site

    Fort Myers, Florida, 33912, United States

  • Altimmune Clinical Study Site

    University Park, Florida, 34201, United States

  • Altimmune Clinical Study Site

    North Canton, Ohio, 44720, United States

  • Altimmune Clinical Study Site

    Tulsa, Oklahoma, 74136, United States

  • Altimmune Clinical Study Site

    Philadelphia, Pennsylvania, 19104, United States

  • Altimmune Clinical Study Site

    Providence, Rhode Island, 02923, United States

  • Altimmune Clinical Study Site

    Charleston, South Carolina, 29425, United States

  • Altimmune Clinical Study Site

    Charlottesville, Virginia, 22903, United States

  • Altimmune Clinical Study Site

    Richmond, Virginia, 23298, United States

  • Altimmune Clinical Study Site

    Los Angeles, California, 90038, United States

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