Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-03-11 @ 4:01 PM
Study NCT ID:
NCT06845202
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2025-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2025-02-20', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part A: Frequency of Adverse Events (AEs)', 'timeFrame': 'Up to 9 months'}, {'measure': 'Part B: Frequency of Adverse Events', 'timeFrame': 'Up to 12 months'}], 'secondaryOutcomes': [{'measure': 'Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-4324 in Plasma', 'timeFrame': 'Predose and up to 3 days postdose'}, {'measure': 'Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-4324 in Plasma', 'timeFrame': 'Predose and up to 3 days postdose'}, {'measure': 'Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-4324 in Plasma', 'timeFrame': 'Predose and up to 3 days postdose'}, {'measure': 'Part A: Fraction of ALN-4324 excreted in urine', 'timeFrame': 'Predose and up to 24 hours postdose (fe)'}, {'measure': 'Part B: Change from Baseline in HbA1c', 'timeFrame': 'Baseline up to 6 months'}, {'measure': 'Part B: Response to Glucose Tolerance Test', 'timeFrame': 'Predose and up to 2 hours postdose'}, {'measure': 'Part B: Concentrations of ALN-4324 in Plasma', 'timeFrame': 'Predose and up to 4 hours postdose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['siRNA', 'RNAi therepeutic'], 'conditions': ['Obese or Overweight Healthy Volunteers', 'Type 2 Diabetes Mellitus (T2DM)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to:\n\n* evaluate the safety and tolerability of single ascending doses of ALN-4324 in healthy volunteers and to characterize the single-dose PK of ALN-4324\n* evaluate the efficacy, safety, tolerability, and pharmacodynamics (PD) of multiple doses of ALN-4324 in adult overweight to obese patients with T2DM'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPart A:\n\n* Has a body mass index (BMI) of ≥27 kg/m\\^2 and \\<40 kg/m\\^2\n\nPart B:\n\n* Is an adult patient with a confirmed diagnosis of T2DM\n* Has a hemoglobin A1c (HbA1c) ≥7% to \\<10.5%\n* Has a BMI of ≥25 kg/m\\^2 and \\<45 kg/m\\^2\n* Is on a stable dose of either metformin or metformin and a sodium-glucose cotransporter 2 inhibitor (SGLT2i)\n\nExclusion Criteria:\n\nPart A:\n\n* Has known human immunodeficiency virus (HIV) infection; or known current or chronic hepatitis C virus or hepatitis B virus infection\n\nPart B:\n\n* Receiving therapies for chronic weight management or antidiabetic medications other than metformin and SGLT2i\n\nNote: other protocol defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT06845202', 'briefTitle': 'A Study to Evaluate ALN-4324 in Overweight to Obese Healthy Volunteers and in Overweight to Obese Patients With T2DM', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alnylam Pharmaceuticals'}, 'officialTitle': 'A Phase 1/2, Randomized, Double-blind, Placebo-controlled 2-part Study of the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Single Dose ALN-4324 in Overweight to Obese Adult Healthy Volunteers and Multiple Dose ALN-4324 in Overweight to Obese Patients With Type 2 Diabetes Mellitus (T2DM)', 'orgStudyIdInfo': {'id': 'ALN-4324-001'}, 'secondaryIdInfos': [{'id': '2024-519005-35-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: ALN-4324', 'description': 'Participants will be administered a single dose of ALN-4324.', 'interventionNames': ['Drug: ALN-4324']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part A: Placebo', 'description': 'Participants will be administered a single dose of placebo.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: ALN-4324', 'description': 'Participants will be administered multiple doses of ALN-4324', 'interventionNames': ['Drug: ALN-4324']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part B: Placebo', 'description': 'Participants will be administered multiple doses of placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ALN-4324', 'type': 'DRUG', 'description': 'ALN-4324 will be administered subcutaneously (SC)', 'armGroupLabels': ['Part A: ALN-4324', 'Part B: ALN-4324']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo will be administered SC', 'armGroupLabels': ['Part A: Placebo', 'Part B: Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91763', 'city': 'Montclair', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 34.07751, 'lon': -117.68978}}, {'zip': '20009', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}, {'zip': '08009', 'city': 'Berlin', 'state': 'New Jersey', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 39.79123, 'lon': -74.92905}}, {'zip': '28112', 'city': 'Monroe', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 34.98543, 'lon': -80.54951}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': 'B7600', 'city': 'Mar del Plata', 'state': 'B', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -38.00042, 'lon': -57.5562}}, {'zip': 'T4000IHE', 'city': 'San Miguel de Tucumán', 'state': 'T', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -26.81601, 'lon': -65.21051}}, {'zip': 'C1060', 'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1061AAE', 'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1061', 'city': 'Buenos Aires', 'status': 'NOT_YET_RECRUITING', 'country': 'Argentina', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'V5Y 3W2', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'L4K 4M2', 'city': 'Concord', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 43.80011, 'lon': -79.48291}}, {'zip': 'H3P 3P1', 'city': 'Mount Royal', 'state': 'Quebec', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 45.51675, 'lon': -73.64918}}, {'zip': '7500710', 'city': 'Santiago', 'state': 'RM', 'status': 'NOT_YET_RECRUITING', 'country': 'Chile', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '7770086', 'city': 'Santiago', 'state': 'RM', 'status': 'NOT_YET_RECRUITING', 'country': 'Chile', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '8320000', 'city': 'Santiago', 'state': 'RM', 'status': 'NOT_YET_RECRUITING', 'country': 'Chile', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': -33.45694, 'lon': -70.64827}}, {'zip': '45355', 'city': 'Essen', 'state': 'Northwest', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '45355', 'city': 'Essen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'zip': '80-546', 'city': 'Gdansk', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 54.35227, 'lon': 18.64912}}, {'zip': '20-884', 'city': 'Lublin', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 51.25058, 'lon': 22.57009}}, {'zip': '33-100', 'city': 'Tarnów', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 50.01381, 'lon': 20.98698}}, {'zip': '02-507', 'city': 'Warsaw', 'status': 'NOT_YET_RECRUITING', 'country': 'Poland', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'centralContacts': [{'name': 'Alnylam Clinical Trial Information Line', 'role': 'CONTACT', 'email': 'clinicaltrials@alnylam.com', 'phone': '1-877-ALNYLAM'}, {'name': 'Alnylam Clinical Trial Information Line', 'role': 'CONTACT', 'email': 'clinicaltrials@alnylam.com', 'phone': '1-877-256-9526'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alnylam Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Access to Anonymized individual participant data that support these results is made available 12 months after study completion and not less than 12 months after the product and indication have been approved in the US and/or the EU.\n\nAccess to data may be declined where there is likelihood a patient could be identified or other feasibility issue, where there is a potential conflict of interest, planned business activities or an actual or potential competitive risk. Data will be provided contingent upon the approval of a research proposal and the execution of a data sharing agreement. Timeframes for data access may vary and can take up to 6 months or more.\n\nRequests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alnylam Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}