NCT05562934

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

A Multi-center, Randomized, Double-blind, Parallel-group, 20-week Dose-finding Study to Evaluate Efficacy, Safety, and Tolerability of XXB750 in Patients With Resistant Hypertension

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 189 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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).

Detailed description

Subjects will enter run-in period which lasts for approximately 2 weeks. The study duration is for 20 weeks during which each participant will receive a total of 3 doses of study medication (in addition to 1 dose of study medication during run-in). Participants will be followed to monitor their safety for an additional 8 weeks during which time no active study medication will be given.

Conditions

• Resistant Hypertension

Interventions

Type	Name	Description
BIOLOGICAL	XXB750 drug	SC injection
OTHER	Placebo	SC injection

Timeline

• Start date: 2022-11-08
• Primary completion: 2024-07-02
• Completion: 2024-08-27
• First posted: 2022-10-03
• Last updated: 2026-01-12
• Results posted: 2025-10-24

Locations

78 sites across 16 countries: United States, Australia, Austria, Bulgaria, China, Czechia, France, Germany, Italy, Japan, Netherlands, Poland, Slovakia, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated drug study