Alcohol-associated Liver DiseasePhase 2NCT07009860
RESTORE TRIAL: Study of the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
A Phase 2 study testing Pemvidutide in people with Alcohol-associated Liver Disease, run by Altimmune, Inc. at 37 sites in 2 countries.
Trial summary
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Alcohol-associated Liver Disease
- What is being tested?
- Pemvidutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 121 participants
- Where
- 37 sitesin 2 countries
- Study dates
- 16 Jun 2025to 30 Sep 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- Male or female ages 18 to 75 years, inclusive
- Overweight or obesity, defined as BMI ≥ 25 kg/m2
- History of alcohol misuse for the prior 3 years, with an alcohol intake ≥ 50 grams per day for males and ≥ 40 grams per day for females on average in the past year
- Evidence of recent alcohol use, defined as PEth level ≥ 35 ng/mL at screening
- Liver stiffness of 10.0-24.9 kPa by VCTE, inclusive
Who cannot join
- Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization
- History of hospitalization for alcohol withdrawal within the past year
- History of seizures related to alcohol within the past year
- History and/or current diagnosis of schizophrenia, bipolar disorder, psychotic disorder, or another severe psychiatric disorder, unless documented as well-controlled by the Investigator for at least 6 months prior to screening and cleared by the Medical Monitor
- Attempted suicide and/or serious suicidal intention or plan in the past 10 years
Trial locations and contacts
37 sites in 2 countries.
37 sites in 2 countries
United States36 sites
Altimmune Clinical Study Site
Atlanta, Georgia, 30309
Altimmune Clinical Study Site
Bastrop, Louisiana, 71220
Altimmune Clinical Study Site
Bradenton, Florida, 34201
Altimmune Clinical Study Site
Brownsville, Texas, 78520
Altimmune Clinical Study Site
Dallas, Texas, 75390
Altimmune Clinical Study Site
Doral, Florida, 33122
Altimmune Clinical Study Site
Edinburg, Texas, 78539
Altimmune Clinical Study Site
Fort Myers, Florida, 33192
Altimmune Clinical Study Site
Fresno, California, 93720
Altimmune Clinical Study Site
Houston, Texas, 77030
Altimmune Clinical Study Site
Houston, Texas, 77079
Altimmune Clinical Study Site
Indianapolis, Indiana, 46202
Altimmune Clinical Study Site
La Jolla, California, 92037
Altimmune Clinical Study Site
Las Vegas, Nevada, 89106
Altimmune Clinical Study Site
Louisville, Kentucky, 40202
Altimmune Clinical Study Site
Manhasset, New York, 11030
Altimmune Clinical Study Site
Marrero, Louisiana, 70072
Altimmune Clinical Study Site
Miami, Florida, 33125
Altimmune Clinical Study Site
Miami, Florida, 33165
Altimmune Clinical Study Site
Miami Lakes, Florida, 33122
Altimmune Clinical Study Site
Naples, Florida, 34102
Altimmune Clinical Study Site
New York, New York, 10032
Altimmune Clinical Study Site
North Little Rock, Arkansas, 72117
Altimmune Clinical Study Site
Orlando, Florida, 32803
Altimmune Clinical Study Site
Pasadena, California, 91105
Altimmune Clinical Study Site
Peoria, Arizona, 85381
Altimmune Clinical Study Site
San Antonio, Texas, 78215
Altimmune Clinical Study Site
San Antonio, Texas, 78251
Altimmune Clinical Study Site
Seattle, Washington, 98105
Altimmune Clinical Study Site
St Louis, Missouri, 63123
Altimmune Clinical Study Site
Syracuse, New York, 13210
Altimmune Clinical Study Site
Tucson, Arizona, 85712
Altimmune Clinical Study Site
Waco, Texas, 76710
Altimmune Clinical Study Site
West Monroe, Louisiana, 71291
Altimmune Clinical Study Site
Westlake, Ohio, 44145
Altimmune Clinical Study Site
Wilmington, North Carolina, 28403
About this study
Official title: RESTORE TRIAL: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD.
- Conditions
- Alcohol-associated Liver Disease
- Being tested
- Pemvidutide, Placebo
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 Injection
PlaceboOther
Placebo SC Injection
| Study group | Role | What they receive |
|---|---|---|
| Pemvidutide 2.4 mg | Active comparator | 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.
Relative (%) reduction in liver stiffness by VCTE compared to baseline
Measured: Week 48 and 24
Secondary outcomes (2)
Absolute reduction in liver stiffness by vibration controlled transient elastography (VCTE)
Measured: Week 48 and 24
Absolute reduction in the Enhanced Liver Fibrosis (ELF) compared to baseline
Measured: Week 48 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start16 Jun 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcohol-associated Liver DiseaseStudies 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
- 121 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
- NCT07009860
- Sponsor's protocol ID
- ALT-801-241
- Status last verified
- Aug 2026
- First submitted
- 5 Jun 2025
- Last updated
- 17 Aug 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 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTORE TRIAL: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
- ClinicalTrials.gov ID
- NCT07009860
- Acronym / sponsor ID
- ALT-801-241
- Conditions
- Alcohol-associated Liver Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Altimmune, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 8 Jun 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 subjects with ALD.
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 | Active comparator | 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)
- Male or female ages 18 to 75 years, inclusive
- Overweight or obesity, defined as BMI ≥ 25 kg/m2
- History of alcohol misuse for the prior 3 years, with an alcohol intake ≥ 50 grams per day for males and ≥ 40 grams per day for females on average in the past year
- Evidence of recent alcohol use, defined as PEth level ≥ 35 ng/mL at screening
- Liver stiffness of 10.0-24.9 kPa by VCTE, inclusive
Key exclusion criteria (5 listed)
- Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization
- History of hospitalization for alcohol withdrawal within the past year
- History of seizures related to alcohol within the past year
- History and/or current diagnosis of schizophrenia, bipolar disorder, psychotic disorder, or another severe psychiatric disorder, unless documented as well-controlled by the Investigator for at least 6 months prior to screening and cleared by the Medical Monitor
- Attempted suicide and/or serious suicidal intention or plan in the past 10 years
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 Injection | Drug | Pemvidutide 2.4 mg |
| PlaceboPlacebo SC Injection | Other | Placebo |
Primary outcome
Relative (%) reduction in liver stiffness by VCTE compared to baseline
Time frame: Week 48 and 24
2 secondary outcomes
Absolute reduction in liver stiffness by vibration controlled transient elastography (VCTE)
Time frame: Week 48 and 24
Absolute reduction in the Enhanced Liver Fibrosis (ELF) compared to baseline
Time frame: Week 48 and 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 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.
37 sites in 2 countries: 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-associated Liver Disease, run by Altimmune, Inc. at 37 sites in 2 countries.
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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, Puerto Rico. 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?
This study is still under way. Results are not available in the source record yet.
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?
Relative (%) reduction in liver stiffness by VCTE compared to baseline (time frame: Week 48 and 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 17 Aug 2026.