A Study to Investigate Tonlamarsen for the Treatment of Adults With Uncontrolled Hypertension (KARDINAL)

Summary

The purpose of this study is to evaluate the blood pressure (BP)-lowering efficacy of tonlamarsen in adult participants who, despite taking 2 or more antihypertensive medications, have not achieved their target blood pressure (BP).

Timeline

Start

2025-04-10

Primary completion

2026-01-12

Completion

2026-03-17

Outcome

Mixed primary results

paper with a LS mean difference of -44.1% (97.5% CI: -51.9% to -36.4%; P < 0.0001). PMID 41949512 ↗

paper with a LS mean difference of -0.1 mm Hg (95% CI: -4.5 to -4.4 mm Hg; P = 0.97). PMID 41949512 ↗

release “results from KARDINAL, a Phase 2 clinical trial evaluating the effects of tonlamarsen in patients with uncontrolled hypertension” kardigan.bio ↗

release “reduction in AGT levels, with patients receiving five monthly doses of 90 mg tonlamarsen achieving a 67% mean reduction from baseline to Week 20” kardigan.bio ↗

release “p<0.0001, co-primary endpoint” kardigan.bio ↗

release “Reduction in oSBP from baseline to Week 20 did not differ significantly between treatment groups” kardigan.bio ↗

release “p=0.97, co-primary endpoint” kardigan.bio ↗

Publications

• Laffin LJ, Wang Q, Sarraju A, Touyz RM, Schlaich MP, Cohen DL, Mahfoud F, Mitchell LM, Mitchell J, Wolski K, Dennis P, Akere A, Li W, Chen G, Cohen YZ, Kim J, Cooper CG, Ramesan P, Edelberg JM, Nissen SE; KARDINAL Investigators. Efficacy of Tonlamarsen in Patients With Uncontrolled Hypertension: The KARDINAL Phase 2 Randomized Clinical Trial. J Am Coll Cardiol. 2026 May 12;87(18):2508-2520. doi: 10.1016/j.jacc.2026.03.034. Epub 2026 Mar 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tonlamarsen	Unknown	90 mg	Subcutaneous

Indications