Phase 2b Study to Test the Safety and Effectiveness of Tonlamarsen in Adults Recently Hospitalized for Acute Severe Hypertension

What this Trial Is About

Researchers are evaluating the effects of tonlamarsen, an investigational drug, in adults who were recently hospitalized due to acute severe hypertension, including hypertensive emergency and urgency. This Phase 2b study aims to measure how well tonlamarsen lowers blood pressure and its safety compared to a placebo. The drug works by blocking the livers production of angiotensinogen, a protein involved in blood pressure regulation. Participants will receive either tonlamarsen or a placebo via subcutaneous injections once every four weeks for approximately three months, totaling three doses. The study is designed as a randomized, double-blind, placebo-controlled trial with parallel groups. The research includes two parts Part A focuses on clinical and biomarker variability, while Part B assesses the pharmacodynamic effects on plasma angiotensinogen levels and blood pressure at Weeks 4 and 12. Throughout the study, participants will visit the clinic about seven times for evaluations, tests, and follow-up. Researchers will monitor blood pressure using office and daily home measurements, as well as blood levels of angiotensinogen. Safety and tolerability of tonlamarsen will be assessed up to Week 36. Participation involves regular checkups and blood tests to understand the drugs impact and side effects over time.

Study of Efficacy and Safety of Tonlamarsen in Participants With a Recent Hospitalization and a Concurrent Episode of Acute Severe Hypertension