An Efficacy, Safety, Tolerability and Dose Finding Study of XXB750 in Resistant Hypertension Patients.

Summary

The purpose of this 20-week randomized double-blind study in patients with resistant hypertension (rHTN) is to evaluate the efficacy, safety, and tolerability, of different doses of XXB750 administered as subcutaneous (SC) injections, compared to placebo. Since all study participants will be patients with rHTN, all study treatments will be given on top of maximally tolerated background antihypertensive therapy recommended by international guidelines for treatment of HTN (i.e., a thiazide or a thiazide-like diuretic, an angiotensin converting enzyme inhibitor (ACEi) or an angiotensin receptor blocker (ARB), and a long-acting dihydropyridine calcium channel blocker (CCB).

Timeline

Start

2022-11-08

Primary completion

2024-07-02

Completion

2024-08-27

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs XXB750 30 mg vs XXB750 60 mg vs XXB750 120 mg vs XXB750 120 mg/240 mg; p = 0.5651 NCT05562934 ↗

paper However, paradoxically, there was no significant dose-dependent change from baseline in mean 24-hour SBP at week 12. PMID 41563174 ↗

paper In fact, none of the doses of XXB750 had a greater BP-lowering effect than placebo. PMID 41563174 ↗

Publications

• White WB, Azizi M, Ferdinand K, Cohen DL, Nuhrenberg T, Lefkowitz M, Jiao R, Rizkala AR, Maboudian M, Williams B. Natriuretic Peptide Receptor-1 Agonist for Resistant Hypertension: A Randomized Phase 2 Trial. J Am Coll Cardiol. 2026 May 12;87(18):2373-2387. doi: 10.1016/j.jacc.2025.11.045. Epub 2026 Jan 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	XXB750	Monoclonal antibody	30 mg	Subcutaneous
Subject	XXB750	Monoclonal antibody	60 mg	Subcutaneous
Subject	XXB750	Monoclonal antibody	120 mg	Subcutaneous
Subject	XXB750	Monoclonal antibody	240 mg	Subcutaneous

Indications