Study of the Efficacy and Safety of NST-1024 Versus Placebo in Subjects With Hypertriglyceridemia
- Registration Number
- NCT05889156
- Lead Sponsor
- NorthSea Therapeutics B.V.
- 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:
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Matched Placebo Placebo - NST-1024 NST-1024 NST-1024 400 mg BID
- Primary Outcome Measures
Name Time Method Evaluate the efficacy of NST-1024 by percentage change in TG 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 Outcome Measures
Name Time Method Percent Change in Lipoprotein a 4 weeks Percent change in Lp(a) from baseline to Week 4.
Change in insulin resistance. 4 weeks Change in insulin resistance, as assessed by the homeostasis model index insulin resistance, from baseline to Week 4
Change in lipoprotein associated phospholipase A2 4 weeks Percent change in lipoprotein associated phospholipase A2 from baseline to Week 4
Percent Change in remnant-like particle cholesterol (RLP-C) 4 weeks Percent Change in RLP-C from baseline to Week 4.
Change in hsCRP 4 weeks Change in hsCRP from baseline to Week 4
Percent change in Apolipoprotein B and Apolipoprotein C3 4 weeks Percent changes in ApoB and ApoC3 from baseline to Week 4.
Changes in fasting plasma glucose, fasting plasma insulin, and HbA1c 4 weeks Changes in fasting plasma glucose (FPG), fasting plasma insulin (FPI) and HbA1c from baseline to Week 4
Percent Change in Cholesterol Values 4 weeks Percent changes in TC, HDL-C, LDL-C, calculated. non-HDL-C, and VLDL-C from baseline to Week 4
Safety Assessments ~ 8 weeks Incidence of Treatment-Emergent Adverse Events and abnormalities in clinical laboratory measurements (chemistry, haematology, and urinalysis), 12-lead ECGs, blood pressure, and physical examinations will be evaluated and monitored for any safety events through the study duration from screening through follow up.
Related Research Topics
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Trial Locations
- Locations (31)
University of Alabama - Heersink School of Medicine
🇺🇸Birmingham, Alabama, United States
Alliance for Multispecialty Research, LLC (AMR) - Daphne
🇺🇸Daphne, Alabama, United States
Alliance for Multispecialty Research, LLC (AMR) - Phoenix
🇺🇸Tempe, Arizona, United States
Velocity Clinical Research, San Diego
🇺🇸La Mesa, California, United States
Velocity Clinical Research, North Hollywood
🇺🇸North Hollywood, California, United States
Velocity Clinical Research - Costal Heart
🇺🇸Santa Ana, California, United States
Lynn Institute of Denver
🇺🇸Aurora, Colorado, United States
Velocity Clinical Research, New Smyrna Beach
🇺🇸Edgewater, Florida, United States
Clearwater Cardiovascular Consultants
🇺🇸Largo, Florida, United States
Floridian Clinical Research
🇺🇸Miami Lakes, Florida, United States
Scroll for more (21 remaining)University of Alabama - Heersink School of Medicine🇺🇸Birmingham, Alabama, United States