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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-519005-35-00 | EU Trial (CTIS) Number |
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The purpose of this study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: ALN-4324 | Experimental | Participants will be administered a single dose of ALN-4324. |
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| Part A: Placebo | Placebo Comparator | Participants will be administered a single dose of placebo. |
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| Part B: ALN-4324 | Experimental | Participants will be administered multiple doses of ALN-4324 |
|
| Part B: Placebo | Placebo Comparator | Participants will be administered multiple doses of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-4324 | Drug | ALN-4324 will be administered subcutaneously (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Frequency of Adverse Events (AEs) | Up to 9 months | |
| Part B: Frequency of Adverse Events | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-4324 in Plasma | Predose and up to 3 days postdose | |
| Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-4324 in Plasma | Predose and up to 3 days postdose |
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Inclusion Criteria:
Part A:
Part B:
Exclusion Criteria:
Part A:
Part B:
Note: other protocol defined inclusion/exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alnylam Clinical Trial Information Line | Contact | 1-877-ALNYLAM | clinicaltrials@alnylam.com | |
| Alnylam Clinical Trial Information Line | Contact | 1-877-256-9526 | clinicaltrials@alnylam.com |
| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Alnylam Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Trial Site | Completed | Montclair | California | 91763 | United States | |
| Clinical Trial Site |
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.
Access 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.
Requests for access to data can be submitted via the website www.vivli.org. Questions can also be directed to datasharing@alnylam.com.
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| Placebo | Drug | Placebo will be administered SC |
|
| Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-4324 in Plasma | Predose and up to 3 days postdose |
| Part A: Fraction of ALN-4324 excreted in urine | Predose and up to 24 hours postdose (fe) |
| Part B: Change from Baseline in HbA1c | Baseline up to 6 months |
| Part B: Response to Glucose Tolerance Test | Predose and up to 2 hours postdose |
| Part B: Concentrations of ALN-4324 in Plasma | Predose and up to 4 hours postdose |
| Completed |
| Washington D.C. |
| District of Columbia |
| 20009 |
| United States |
| Clinical Trial Site | Completed | Miami | Florida | 33126 | United States |
| Clinical Trial Site | Completed | Marlton | New Jersey | 08053 | United States |
| Clinical Trial Site | Completed | Monroe | North Carolina | 28112 | United States |
| Clinical Trial Site | Completed | Dallas | Texas | 75230 | United States |
| Clinical Trial Site | Completed | Dallas | Texas | 75246 | United States |
| Clinical Trial Site | Completed | Buenos Aires | C1060 | Argentina |
| Clinical Trial Site | Completed | Buenos Aires | C1061AAE | Argentina |
| Clinical Trial Site | Completed | Buenos Aires | C1061 | Argentina |
| Clinical Trial Site | Completed | San Miguel de Tucumán | T4000IHE | Argentina |
| Clinical Trial Site | Completed | Concord | L4K 4M2 | Canada |
| Clinical Trial Site | Recruiting | Mount Royal | H3P 3P1 | Canada |
| Clinical Trial Site | Completed | Vancouver | V5Y 3W2 | Canada |
| Clinical Trial Site | Completed | Santiago | 7500710 | Chile |
| Clinical Trial Site | Completed | Santiago | 7770086 | Chile |
| Clinical Trial Site | Completed | Santiago | 8320000 | Chile |
| Clinical Trial Site | Completed | Essen | 45355 | Germany |
| Clinical Trial Site | Completed | Gdansk | 80-546 | Poland |
| Clinical Trial Site | Completed | Tarnów | 33-100 | Poland |
| Clinical Trial Site | Completed | Warsaw | 02-507 | Poland |
| Clinical Trial Site | Completed | Wroclaw | 51-162 | Poland |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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