Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-01-06 @ 7:09 PM
Study NCT ID:
NCT07009860
Status:
RECRUITING
Last Update Posted:
2025-07-09
First Post:
2025-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-16', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2025-06-05', 'studyFirstSubmitQcDate': '2025-06-05', 'lastUpdatePostDateStruct': {'date': '2025-07-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative (%) change in liver stiffness by VCTE compared to baseline at Week 24', 'timeFrame': 'Week 24'}], 'secondaryOutcomes': [{'measure': 'Relative (%) change in liver stiffness by VCTE compared to baseline at Week 48', 'timeFrame': 'Week 24 and 48'}, {'measure': 'Absolute change in the Enhanced Liver Fibrosis (ELF) score at Weeks 24 and 48 compared to baseline', 'timeFrame': 'Week 24 and 48'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Liver Disease']}, 'descriptionModule': {'briefSummary': 'This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of pemvidutide in subjects with ALD.\n\n* Pemvidutide: 2.4 mg SC once weekly\n* Placebo: Placebo SC once weekly'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female ages 18 to 75 years, inclusive\n2. Overweight or obesity, defined as BMI ≥ 25 kg/m2\n3. 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\n4. Liver stiffness of 10.0-18.5 kPa by VCTE, inclusive\n\nExclusion Criteria:\n\n1. Presence of clinically significant alcohol withdrawal symptoms, defined as CIWA-Ar score ≥ 10 at screening and/or prior to randomization\n2. History of hospitalization for alcohol intoxication or alcohol withdrawal within the past year\n3. History of seizures related to alcohol within the past year\n4. History and/or current DSM-5 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'}, 'identificationModule': {'nctId': 'NCT07009860', 'briefTitle': 'RESTORE TRIAL: A Phase 2 Study Evaluating the Efficacy and Safety of Pemvidutide in the Treatment of Alcohol-Associated Liver Disease (ALD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Altimmune, Inc.'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'ALT-801-241'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pemvidutide 2.4 mg', 'interventionNames': ['Drug: Pemvidutide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Pemvidutide', 'type': 'DRUG', 'description': 'Pemvidutide 2.4 mg', 'armGroupLabels': ['Pemvidutide 2.4 mg']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Subcutaneous injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72117', 'city': 'North Little Rock', 'state': 'Arkansas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 34.76954, 'lon': -92.26709}}, {'zip': '93720', 'city': 'Fresno', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '91105', 'city': 'Pasadena', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 34.14778, 'lon': -118.14452}}, {'zip': '80113', 'city': 'Englewood', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 39.64777, 'lon': -104.98776}}, {'zip': '34201', 'city': 'Bradenton', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study 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States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '34102', 'city': 'Naples', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 26.14234, 'lon': -81.79596}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '32127', 'city': 'Port Orange', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 29.13832, 'lon': -80.99561}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '71220', 'city': 'Bastrop', 'state': 'Louisiana', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 32.77828, 'lon': -91.91144}}, {'zip': '70072', 'city': 'Marrero', 'state': 'Louisiana', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 29.89937, 'lon': -90.10035}}, {'zip': '64131', 'city': 'Kansas City', 'state': 'Missouri', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '89106', 'city': 'Las Vegas', 'state': 'Nevada', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '44145', 'city': 'Westlake', 'state': 'Ohio', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 41.45532, 'lon': -81.91792}}, {'zip': '78520', 'city': 'Brownsville', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 25.90175, 'lon': -97.49748}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78539', 'city': 'Edinburg', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 26.30174, 'lon': -98.16334}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77079', 'city': 'Houston', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76710', 'city': 'Waco', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 31.54933, 'lon': -97.14667}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '00927', 'city': 'San Juan', 'status': 'NOT_YET_RECRUITING', 'country': 'Puerto Rico', 'facility': 'Altimmune Clinical Study Site', 'geoPoint': {'lat': 18.46633, 'lon': -66.10572}}], 'centralContacts': [{'name': 'Julio Gutierrez, MD', 'role': 'CONTACT', 'email': 'information@altimmune.com', 'phone': '240-654-1450'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Altimmune, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}