A Study to Evaluate Efficacy and Safety of ALN-AGT01 in Patients With Mild To-Moderate Hypertension

Completed · Phase 2 · Has a placebo group

Conditions studied: Hypertension

In brief

The purpose of this study is to evaluate the effect of ALN-AGT01 on systolic and diastolic blood pressure and to characterize the pharmacodynamic (PD) effects and safety of ALN-AGT01.

Key facts

Study ID

NCT04936035

Run by

Alnylam Pharmaceuticals

People needed

394

Starts

2021-07-07

Expected to finish

2024-12-05

Last updated by the study team

2025-12-23

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Daytime mean SBP ≥135 mmHg and ≤160 mmHg by ABPM, without antihypertensive medication

You may not qualify if…

• Secondary hypertension, orthostatic hypotension
• Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2× upper limit of normal (ULN)
• Elevated potassium >5 mEq/L
• Estimated glomerular filtration rate (eGFR) of ≤30 mL/min/1.73m\^2
• Received an investigational agent within the last 30 days
• Type 1 diabetes mellitus, poorly controlled Type 2 diabetes mellitus, newly diagnosed Type 2 diabetes mellitus
• History of any cardiovascular event within 6 months prior to randomization
• History of intolerance to SC injection(s)

Where it is running

• Clinical Trial Site — Tempe, Arizona, United States
• Clinical Trial Site — Tempe, Arizona, United States
• Clinical Trial Site — Beverly Hills, California, United States
• Clinical Trial Site — La Mesa, California, United States
• Clinical Trial Site — Los Angeles, California, United States
• Clinical Trial Site — San Diego, California, United States
• Clinical Trial Site — South Gate, California, United States
• Clinical Trial Site — Vista, California, United States
• Clinical Trial Site — Washington D.C., District of Columbia, United States
• Clinical Trial Site — Clearwater, Florida, United States
• Clinical Trial Site — Coral Gables, Florida, United States
• Clinical Trial Site — Fleming Island, Florida, United States
• Clinical Trial Site — Hollywood, Florida, United States
• Clinical Trial Site — Hollywood, Florida, United States
• Clinical Trial Site — Inverness, Florida, United States
• Clinical Trial Site — Jacksonville, Florida, United States
• Clinical Trial Site — Jacksonville, Florida, United States
• Clinical Trial Site — Jacksonville, Florida, United States
• Clinical Trial Site — Miami, Florida, United States
• Clinical Trial Site — Miami, Florida, United States
• Clinical Trial Site — Naples, Florida, United States
• Clinical Trial Site — Orlando, Florida, United States
• Clinical Trial Site — Acworth, Georgia, United States
• Clinical Trial Site — Columbus, Georgia, United States
• Clinical Trial Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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