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
Overview
- Phase
- Phase 2
- Intervention
- Placebo
- Conditions
- High Triglycerides
- Sponsor
- NorthSea Therapeutics B.V.
- Enrollment
- 50
- Locations
- 31
- Primary Endpoint
- Evaluate the efficacy of NST-1024 by percentage change in TG
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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:
- A 3-week screening period that includes a TG qualifying period, and
- 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Matched Placebo
Intervention: Placebo
NST-1024
NST-1024 400 mg BID
Intervention: NST-1024
Outcomes
Primary Outcomes
Evaluate the efficacy of NST-1024 by percentage change in TG
Time Frame: 4 weeks
Evaluate the efficacy of NST-1024 400 mg BID by assessment of the percentage change in TG from baseline after 28 days of treatment
Secondary Outcomes
- Safety Assessments(~ 8 weeks)
- Change in insulin resistance.(4 weeks)
- Change in lipoprotein associated phospholipase A2(4 weeks)
- Percent Change in Lipoprotein a(4 weeks)
- Percent Change in remnant-like particle cholesterol (RLP-C)(4 weeks)
- Change in hsCRP(4 weeks)
- Percent change in Apolipoprotein B and Apolipoprotein C3(4 weeks)
- Changes in fasting plasma glucose, fasting plasma insulin, and HbA1c(4 weeks)
- Percent Change in Cholesterol Values(4 weeks)