Alcohol Use Disorder (AUD)Phase 2NCT06987513
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
A Phase 2 study testing Pemvidutide in people with Alcohol Use Disorder (AUD), run by Altimmune, Inc. at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcohol Use Disorder (AUD)
- What is being tested?
- Pemvidutide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 12 sitesUnited States
- Study dates
- 15 May 2025to 30 Jul 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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
- 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
- Overweight or obesity, defined as BMI ≥ 25 kg/m2
Who cannot join
- Presence of clinically significant alcohol withdrawal symptoms, as defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization
- History of hospitalization for alcohol intoxication or alcohol withdrawal
- History of alcohol-related disorders including seizures related to alcohol, MalloryWeiss Syndrome, and alcoholic ketoacidosis
- 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
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Altimmune Clinical Study Site
Aurora, Colorado, 80045
Altimmune Clinical Study Site
Charleston, South Carolina, 29425
Altimmune Clinical Study Site
Charlottesville, Virginia, 22903
Altimmune Clinical Study Site
Fort Myers, Florida, 33912
Altimmune Clinical Study Site
Los Angeles, California, 90038
Altimmune Clinical Study Site
New Haven, Connecticut, 06511
Altimmune Clinical Study Site
North Canton, Ohio, 44720
Altimmune Clinical Study Site
Philadelphia, Pennsylvania, 19104
Altimmune Clinical Study Site
Providence, Rhode Island, 02923
Altimmune Clinical Study Site
Richmond, Virginia, 23298
Altimmune Clinical Study Site
Tulsa, Oklahoma, 74136
Altimmune Clinical Study Site
University Park, Florida, 34201
About this study
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
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
- Conditions
- Alcohol Use Disorder (AUD)
- Being tested
- Pemvidutide, Placebo
- Keywords
- Pemvidutide, GLP-1 receptor agonist, Alcohol Use Disorder, Obesity, Overweight, AUD treatment, Phase 2
- Medical subject headings
- Alcoholism, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemvidutideDrug
Pemvidutide 2.4 mg SC once weekly
PlaceboOther
Placebo SC once weekly
| Study group | Role | What they receive |
|---|---|---|
| Pemvidutide 2.4 mg | Experimental | Not described Receives: Drug: Pemvidutide |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to Weeks 21-24
Secondary outcomes (10)
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
Measured: Baseline to Weeks 21-24
Absolute change from baseline in average phosphatidylethanol (PEth) levels at Week 24
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline to Weeks 21-24
Change from baseline at Week 24 in average Drinker Inventory of Consequences - Short Inventory of Problems (DrInc-SIP-2R)
Measured: Baseline to Week 24
Change from baseline at Week 24 in Patient Reported Outcomes Measurement Information System (PROMIS) Negative Alcohol Consequences (NECO) Short Form
Measured: Baseline to Week 24
Percent changes from baseline in body weight
Measured: Baseline to Week 24
Percent change from baseline in BMI
Measured: Baseline to Week 24
Percent change from baseline in waist circumference
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start15 May 2025
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol Use Disorder (AUD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altimmune, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987513
- Sponsor's protocol ID
- ALT-801-231
- Status last verified
- Jul 2026
- First submitted
- 16 May 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06987513
- Acronym / sponsor ID
- ALT-801-231
- Conditions
- Alcohol Use Disorder (AUD)
- Keywords
- Pemvidutide, GLP-1 receptor agonist, Alcohol Use Disorder, Obesity, Overweight, AUD treatment, Phase 2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Altimmune, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 May 2025 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pemvidutide 2.4 mg | Experimental | Drug: Pemvidutide |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 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
- Overweight or obesity, defined as BMI ≥ 25 kg/m2
Key exclusion criteria (5 listed)
- Presence of clinically significant alcohol withdrawal symptoms, as defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization
- History of hospitalization for alcohol intoxication or alcohol withdrawal
- History of alcohol-related disorders including seizures related to alcohol, MalloryWeiss Syndrome, and alcoholic ketoacidosis
- 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
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PemvidutidePemvidutide 2.4 mg SC once weekly | Drug | Pemvidutide 2.4 mg |
| PlaceboPlacebo SC once weekly | Other | Placebo |
Primary outcome
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
10 secondary outcomes
Proportion of subjects achieving a 2-level reduction in WHO risk drinking level
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
Time frame: Baseline to Weeks 21-24
Change from baseline in proportion of subjects achieving no heavy drinking days
Time frame: Baseline to Weeks 21-24
Change from baseline in average percent days completely abstinent
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pemvidutide in people with Alcohol Use Disorder (AUD), run by Altimmune, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the average number of heavy drinking days per week (time frame: Baseline to Weeks 21-24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.