NCT05889156

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

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: NorthSea Therapeutics B.V. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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 15-35 centers in USA.

Conditions

• High Triglycerides

Interventions

Type	Name	Description
DRUG	NST-1024	400 mg BID
OTHER	Placebo	matched placebo to active arm

Timeline

• Start date: 2023-06-30
• Primary completion: 2025-03-18
• Completion: 2025-04-11
• First posted: 2023-06-05
• Last updated: 2025-04-24

Locations

31 sites across 1 country: United States

Regulatory

• FDA-regulated drug study