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The purpose of this study is to:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: ALN-2232 | Experimental | Participants will be administered a single dose of ALN-2232 |
|
| Part A: Placebo | Placebo Comparator | Participants will be administered a single dose of placebo |
|
| Part B: ALN-2232 | Experimental | Participants will be administered multiple doses of ALN-2232 |
|
| Part B: Placebo | Placebo Comparator | Participants will be administered multiple doses of placebo |
|
| Part C: ALN-2232 | Experimental | Participants will be administered multiple doses of ALN-2232 |
|
| Part C: Placebo | Placebo Comparator | Participants will be administered multiple doses of placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALN-2232 | Drug | ALN-2232 will be administered subcutaneously (SC) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Frequency of Adverse Events (AEs) | Up to 12 months | |
| Part B: Percent Change from Baseline in Body Weight | Baseline up to Month 6 | |
| Part C: Percent Change from Baseline in Body Weight | Baseline up to Month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Part A: Change from Baseline in Proteins in Adipose Tissue | Baseline up to Month 12 | |
| Part A: Area Under the Plasma Concentration-time Curve (AUC) of ALN-2232 in Plasma | Predose and up to 15 days postdose |
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Inclusion Criteria:
All Parts:
Exclusion Criteria:
All Parts:
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 | Mount Royal | H3P 3P1 | Canada |
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 |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000098860 | Tirzepatide |
| ID | Term |
|---|---|
| D000067757 | Glucagon-Like Peptide-1 Receptor |
| D000067756 | Glucagon-Like Peptide Receptors |
| D043562 | Receptors, G-Protein-Coupled |
| D011956 | Receptors, Cell Surface |
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| Part C: Tirzepatide | Other | Participants will be administered multiple doses of tirzepatide once weekly |
|
| Placebo | Drug | Placebo will be administered SC |
|
| Tirzepatide | Drug | Tirzepatide will be administered SC |
|
| Part A: Maximum Observed Plasma Concentration (Cmax) of ALN-2232 in Plasma | Predose and up to 15 days postdose |
| Part A: Time to Maximum Plasma Concentration (Tmax) of ALN-2232 in Plasma | Predose and up to 15 days postdose |
| Part A: Fraction of ALN-2232 excreted in urine | Predose and up to 8 days postdose (fe) |
| Part A: Percent Change from Baseline in Body Weight | Baseline up to Month 12 |
| Part B and Part C: Concentrations of ALN-2232 in Plasma | Predose and up to 6 months postdose |
| Part B and Part C: Percent Change from Baseline in Body Weight | Baseline up to Month 12 |
| Part B and Part C: Change from Baseline in Body Fat Mass and Lean Mass | Measured by dual x-ray absorptiometry (DXA) | Baseline up to Month 12 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008565 | Membrane Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011964 | Receptors, Gastrointestinal Hormone |
| D018000 | Receptors, Peptide |