Study of the Efficacy and Safety of NST-1024 Versus Placebo in Subjects With Hypertriglyceridemia

High Triglycerides Clinical Trial

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled 28- Day Phase II Proof of Concept Study to Evaluate the Efficacy and Safety of NST-1024 400 mg BID Versus Placebo in Statin-Naïve or Statin-Stable Hypertriglyceridemic Subjects

Status Recruiting

Clinical Trial Summary

This is a Phase IIa,multicentre proof of concept study consisting of 2 study periods to study Treatment with NST-1024 as an adjunct to diet to reduce triglyceride (TG) levels in subjects with TG levels of ≥500 mg/dL and ≤2000 mg/dL; determined by percentage change in TG from baseline after 28 days of treatment.

The two periods consist of:

1. A 3-week screening period that includes a TG qualifying period, and

2. A 28-days, double-blind, randomized, parallel group, placebo-controlled treatment period.

Subjects will return to the study site for a follow-up visit 2 weeks after the last dose.

Approximately 50 subjects will be randomized at approximately 15-30 centres in USA.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• High Triglycerides
• Hypertriglyceridemia

• NCT number: NCT05889156
• Study type: Interventional
• Source: NorthSea Therapeutics B.V.
• Contact: Brandy Dupee
• Phone: +31 (0) 35 760 65 05
• Email: brandy.dupee@northseatherapeutics.com
• Status: Recruiting
• Phase: Phase 2
• Start date: June 30, 2023
• Completion date: February 29, 2024