Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ALN-AGT01 · 2 trials · 1 indication
24-hour ABPM was programmed to take readings every 20 minutes during the day (6 am to 9:59 pm) and every 30 minutes during the night (10 pm to 5:59 am). An ABPM was considered adequate if: 1. the number of successful daytime readings were ≥33, 2. the number of successful nighttime readings were ≥11, 3. no more than 3 hours are not represented (i.e., 3 sections of 60 minutes where 0 valid readings were obtained). To summarize the 24-hour ABPM, the hourly adjusted mean was calculated. Hourly mean was the average of BP by each hour of the day. The 24-hour mean was the average of the hourly means. Least squares (LS) mean and standard error (SE) were calculated using a mixed model repeated measures (MMRM) approach.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received zilebesiran matching placebo, subcutaneous (SC) injection, once every 3 months (Q3M), with re-randomization at Month 6 to 1 of the initial 4 zilebesiran regimens. Participants will continue their respective zilebesiran regimen up to Month 12 in the DB period and up to 24 additional months in the DB Extension period. Upon implementation of Amendment 6, the DB Extension period was closed. |
| Zilebesiran 150 Milligrams (mg) Once Every 6 Months (Q6M) | EXPERIMENTAL | Participants receive zilebesiran, 150 mg, SC injection, Q6M, during the 12-month DB period. Participants will continue receiving the same zilebesiran regimen for up to 24 additional months in the DB Extension period. Participants in this arm will receive a placebo during those dosing visits when they do not receive zilebesiran to maintain the blind. Upon implementation of Amendment 6, the DB Extension period was closed. |
| Zilebesiran 300 mg Q6M | EXPERIMENTAL | Participants receive zilebesiran, 300 mg, SC injection, Q6M, during the 12-month DB period. Participants will continue receiving the same zilebesiran regimen for up to 24 additional months in the DB Extension period. Participants in this arm will receive a placebo during those dosing visits when they do not receive zilebesiran to maintain the blind. Upon implementation of Amendment 6, the DB Extension period was closed. |
| Zilebesiran 300 mg Q3M | EXPERIMENTAL | Participants receive zilebesiran, 300 mg, SC injection, Q3M, during the 12-month DB period. Participants continue receiving the same zilebesiran regimen for up to 24 additional months in the DB Extension period. Upon implementation of Amendment 6, the DB Extension period was closed. |
| Zilebesiran 600 mg Q6M | EXPERIMENTAL | Participants receive zilebesiran, 600 mg, SC injection, Q6M, during the 12-month DB period. Participants will continue receiving the same zilebesiran regimen for up to 24 additional months in the DB Extension period. Participants in this arm will receive a placebo during those dosing visits when they do not receive zilebesiran to maintain the blind. Upon implementation of Amendment 6, the DB Extension period was closed. |
| Part A: SAD: ALN-AGT01 | EXPERIMENTAL | Participants will be administered a single dose of ALN-AGT01. |
| Part A: SAD: ALN-AGT01-Matching Placebo | PLACEBO_COMPARATOR | Participants will be administered a single dose of ALN-AGT01-matching placebo. |
| Part B: SD: ALN-AGT01 | EXPERIMENTAL | Participants with controlled salt intake will be administered a single dose of ALN-AGT01. |
| Part B: SD: ALN-AGT01-Matching Placebo | PLACEBO_COMPARATOR | Participants with controlled salt intake will be administered a single dose of ALN-AGT01-matching placebo. |
| Part D: MD: ALN-AGT01 + Irbesartan-Matching Placebo | EXPERIMENTAL | Participants, who are obese, will be administered multiple doses of ALN-AGT01 and irbesartan-matching placebo. |
| Part D: MD: ALN-AGT01-Matching Placebo + Irbesartan | ACTIVE_COMPARATOR | Participants, who are obese, will be administered multiple doses of ALN-AGT01-matching placebo and irbesartan. |
| Part E: Open Label: ALN-AGT01 + Irbesartan | EXPERIMENTAL | Participants will be administered a single dose of ALN-AGT01 and multiple doses of irbesartan. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo administered by SC injection |
| ALN-AGT01 | DRUG | ALN-AGT01 administered by SC injection |
| ALN-AGT01-Matching Placebo | DRUG | Normal saline (0.9% NaCl) matching volume of ALN-AGT01 doses will be administered SC. |
| Irbesartan | DRUG | Irbesartan will be administered orally. |
| Irbesartan-Matching Placebo | DRUG | Irbesartan-matching placebo will be administered orally. |
Inclusion Criteria: * Daytime mean SBP ≥135 mmHg and ≤160 mmHg by ABPM, without antihypertensive medication Exclusion Criteria: * Secondary hypertension, orthostatic hypotension * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2× upper limit of normal (ULN) * Elevated potass...
ALN-AGT01 is an investigational drug being developed for the treatment of hypertension, a cardiovascular condition characterized by elevated blood pressure. It is currently in clinical development and has not been approved by regulatory authorities. The drug is being studied in patients with hypertension, including those with mild to moderate forms of the condition.
ALN-AGT01 is a small molecule being developed by Alnylam Pharmaceuticals. While the specific molecular target of ALN-AGT01 has not been disclosed, it is being investigated for its potential to lower blood pressure in patients with hypertension. The drug's mechanism of action is not publicly detailed, but it is being evaluated in clinical trials for its efficacy and safety.
ALN-AGT01 is being developed by Alnylam Pharmaceuticals, Inc., a biopharmaceutical company listed on the NASDAQ under the ticker symbol ALNY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in treating hypertension. Alnylam is known for its focus on RNA interference therapeutics, though ALN-AGT01 is classified as a small molecule.
ALN-AGT01 is currently in Phase 2 clinical development. It has completed two clinical trials, including a Phase 1 study and a Phase 2 study. The drug is investigational and has not received FDA approval. It is being studied for the treatment of hypertension, with the Phase 2 trial evaluating its efficacy and safety in patients with mild to moderate hypertension.
ALN-AGT01 has been studied in two completed clinical trials. The first, NCT03934307, was a Phase 1 study in patients with hypertension conducted in the United Kingdom with 124 participants. The second, NCT04936035, was a Phase 2 study in patients with mild to moderate hypertension conducted in the United States, Canada, Puerto Rico, Ukraine, and the United Kingdom, enrolling 394 participants.
ALN-AGT01 is the primary name for this investigational drug, and no alternative names have been disclosed. It is being developed by Alnylam Pharmaceuticals under this identifier. Patients and healthcare providers should refer to the drug by its official name, ALN-AGT01, when discussing clinical trials or potential treatment options.