A Phase 2 interventional study of Pemvidutide and Placebo in Alcohol Use Disorder (AUD), sponsored by Altimmune, Inc.. Completed at 12 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Altimmune, Inc. · Phase 2, Interventional, and Treatment
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:
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's enrollment of 100 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Altimmune, Inc. is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 4 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Pemvidutide
Other: Placebo
Pemvidutide 2.4 mg SC once weekly
Placebo SC once weekly
Change from baseline in the average number of heavy drinking days per week
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
Time frame: Baseline to Weeks 21-24
Proportion of subjects achieving a 2-level reduction in WHO risk drinking level
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
Time frame: Baseline to Weeks 21-24
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
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
Time frame: Baseline to Weeks 21-24
Change from baseline in proportion of subjects achieving no heavy drinking days
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
Time frame: Baseline to Weeks 21-24
Change from baseline in average percent days completely abstinent
Change from baseline in average percent days completely abstinent using the TLFB method for the 4-week period comprising Week 21 through 24
Time frame: Baseline to Weeks 21-24
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
Plan to share: Yes — It is anticipated that the results of this study will be presented at scientific meetings and/or published in a peer reviewed scientific or medical journal. A Publications Committee, comprised of the Investigators participating in the study and representatives from the Sponsor, as appropriate, will be formed to oversee the publication of the study results, which will reflect the experience of all participating study centers. Subsequently, individual Investigators may publish results from the study in compliance with their agreement with the Sponsor.
No publications or documents are linked to this record.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Pemvidutide
Altimmune, Inc.