NCT06025630

Targeting Endoplasmic Reticulum Stress in Human Hypertension

Recruiting now Phase 1, PHASE2 Last updated 28 March 2025

What this trial tests

Phase 1, PHASE2 trial testing TUDCA in Hypertension in 70 participants. Currently enrolling.

Timeline

15 August 2023

Primary endpoint
31 December 2028

31 December 2028

Quick facts

Lead sponsor	University of North Texas Health Science Center
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	70
Start date	15 August 2023
Primary completion	31 December 2028
Estimated completion	31 December 2028
Sites	1 location across United States

Drugs / interventions tested

• TUDCA — full drug profile →
• Placebo

Conditions studied

• Hypertension — all drugs for Hypertension →

Sponsor

University of North Texas Health Science Center

Who can join

Adults 18 to 80, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is strong evidence suggesting that endoplasmic reticulum stress contributes to neurogenic and vascular hypertension in various animal models, however this has never been explored in humans. Therefore, this project will fill this gap by performing a single-blind, placebo-controlled trial in humans with hypertension.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Inhibition of vascular smooth muscle cell PERK/ATF4 ER stress signaling protects against abdominal aortic aneurysms.
   Callow B, He X, Juriga N, Mangum KD, et al · · 2025 · cited 11× · PMID 39846252 · DOI 10.1172/jci.insight.183959
2. Endoplasmic reticulum stress in disease pathogenesis: its implications for therapy.
   Wei S, Zhang N, Zhang H, Chen Z, et al · · 2026 · PMID 41986307 · DOI 10.1038/s41392-026-02600-z