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The purpose of this study is to evaluate the effect of a single dose of ALN-4324 on whole-body insulin sensitivity in participants with T2DM
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALN-4324 | Experimental | Participants will be administered a single dose of ALN-4324. |
|
| Placebo | Placebo Comparator | Participants will be administered a single dose of placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-4324 | Drug | ALN-4324 will be administered subcutaneously (SC). |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in M-value | M-value is measured as the glucose infusion rate at steady state | Baseline up to Month 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of Adverse Events (AEs) | Up to Month 9 | |
| Change from Baseline in M/I | M/I is measured as the ratio of M-value to insulin concentration [I] at steady state | Baseline up to Month 6 |
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Inclusion Criteria:
Exclusion Criteria:
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 | Recruiting | Chula Vista | California | 91911 | United States |
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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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo |
| Drug |
Placebo will be administered SC. |
|
| Change from Baseline in M-value | M-value is measured as the glucose infusion rate at steady state | Baseline up to Month 6 |
| Change from Baseline in Endogenous Glucose Production (EGP) | Both in the basal state and during steady state during the hyperinsulinemic euglycemic clamp (HEC) procedure | Baseline up to Month 6 |
| Change from Baseline in Hemoglobin A1c (HbA1c) | Baseline up to Month 6 |
| D004700 | Endocrine System Diseases |