NCT07511361

Study of Efficacy and Safety of Tonlamarsen in Participants With Acute Severe Hypertension Recently Discharged From the Hospital

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Tonlamarsen in Participants With Acute Severe Hypertension Recently Discharged From the Hospital

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kardigan, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who were recently discharged from the hospital, after treatment for acute severe hypertension.

Detailed description

The Sponsor is studying an investigational medication called tonlamarsen to determine if it can help people recently treated for acute severe hypertension (hypertensive emergency and urgency). The purpose of this study is to evaluate how well tonlamarsen works compared to a placebo and to see how safe it is for people following a recent episode of acute severe hypertension. Tonlamarsen is designed to block the body's liver from making a protein called angiotensinogen (AGT), which plays a key role in controlling blood pressure. The main goals of the study are: * To assess the effect of tonlamarsen on the amount of AGT in blood over time * To assess the effect of tonlamarsen on blood pressure * To evaluate the safety and tolerability of tonlamarsen Participants will: * Receive monthly doses of tonlamarsen for approximately 3 months * Visit the clinic about 6 times, including initial evaluation, checkups, tests, and follow-up

Conditions

• Hypertension
• Acute Severe Hypertension

Interventions

Type	Name	Description
DRUG	Tonlamarsen	Tonlamarsen will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study
DRUG	Placebo	Placebo will be administered subcutaneously (under the skin) every 4 weeks during the randomized part of the study

Timeline

• Start date: 2026-04-20
• Primary completion: 2026-12-29
• Completion: 2027-02-23
• First posted: 2026-04-06
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study