Approval Probability
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ML Risk
Also known as Zilebesiran
ALN-AGT01 · 5 trials · 4 indications
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.
An AE is any untoward medical occurrence in a patient or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
| Arm | Type | Description |
|---|---|---|
| Zilebesiran 300 mg | EXPERIMENTAL | Participants will be administered 300 mg zilebesiran subcutaneously (SC) once every 6 months as add-on therapy to their standard of care antihypertensive medications. |
| Placebo | PLACEBO_COMPARATOR | Participants will be administered placebo SC once every 6 months as add-on therapy to their standard of care antihypertensive medications. |
| Zilebesiran | EXPERIMENTAL | Participants will receive zilebesiran on Day 1 of the 6-month double-blind (DB) treatment period. Participants must be on stable doses of at least 2, but not more than 4, antihypertensive medications for at least 30 days prior to screening and plan to remain on stable doses of these medications during screening and through the DB treatment period. |
| 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 |
|---|---|---|
| Zilebesiran | DRUG | Zilebesiran will be administered SC |
| Placebo | DRUG | Placebo will be administered SC |
| 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: * Is 18 years or older for patients with established cardiovascular disease (CVD) * Is 55 years or older for patients with high risk for CVD * Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD * Has treated hypertension...
Top 9 of 16 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 5 | PHASE3 | Baxdrostat |
| Eli Lilly and Company | LLY | 4 | PHASE3 | Orforglipron, Clazakizumab |
| Alnylam Pharmaceuticals, Inc | ALNY | 2 | PHASE3 | Zilebesiran, ALN-AGT01 RVR |
| Mineralys Therapeutics, Inc. | MLYS | 1 | PHASE3 | lorundrostat |
| United Therapeutics Corporation | UTHR | 1 | PHASE3 | Ralinepag |
| Novartis AG Sponsored ADR | NVS | 3 | PHASE2 | QCZ484, HJB647 |
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE2 | iloperidone |
| Opus Genetics, Inc. | IRD | 1 | PHASE1 | OPGx-BEST1 |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX340 |
ALN-AGT01 is an investigational RNA therapy being developed for the treatment of hypertension. It is designed for patients with hypertension, including those with mild to moderate disease. It has not been approved for any indication and remains in clinical development.
ALN-AGT01 is being developed by Alnylam Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker ALNY. Alnylam is the sponsor of the clinical program evaluating ALN-AGT01 in hypertension.
ALN-AGT01 is in Phase 2 development for hypertension. Two clinical trials have been completed: a Phase 2 study and a Phase 1 study. No trials are currently active, and the drug is investigational rather than approved.
ALN-AGT01 has been studied in two completed trials. NCT04936035 was a Phase 2 study in patients with mild to moderate hypertension, enrolling 394 participants across the United States, Canada, Puerto Rico, Ukraine, and the United Kingdom. NCT03934307 was a Phase 1 study in hypertension conducted in the United Kingdom with 124 participants.
The ALN-AGT01 clinical program enrolled 518 participants in total across its two completed trials. The Phase 2 trial, NCT04936035, enrolled 394 patients, and the Phase 1 trial, NCT03934307, enrolled 124 patients. Both studies were randomized, double-blind, and placebo-controlled.