drugset / Trial / NCT05889156
Study of the Efficacy and Safety of NST-1024 Versus Placebo in Subjects With Hypertriglyceridemia
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2023-06-30
- Primary completion
- 2025-03-18
- Completion
- 2025-04-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | NST-1024 | Unknown | 400 mg | — |