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 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.
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
Trial Locations
- Locations (31)
Troy Internal Medicine
🇺🇸Troy, Michigan, United States
Cenexel HRI
🇺🇸Berlin, New Jersey, United States
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
Metabolic Research Institute, Inc.
🇺🇸West Palm Beach, Florida, United States
Lifeline Primary Care/ CCT Research
🇺🇸Lilburn, Georgia, United States
Velocity Clinical Research - Boise
🇺🇸Meridian, Idaho, United States
Deaconess Clinic - Indiana
🇺🇸Evansville, Indiana, United States
Velocity Clinical Research, Valparaiso
🇺🇸Valparaiso, Indiana, United States
Alliance for Multispecialty Research, LLC (AMR) - Newton
🇺🇸Newton, Kansas, United States
University of Louisville - UoL Physicians Outpatient Center
🇺🇸Louisville, Kentucky, United States
Clay Platte Family Medicine / CCT Research
🇺🇸Kansas City, Missouri, United States
Velocity Clinical Research - Kearney
🇺🇸Lincoln, Nebraska, United States
Velocity Clinical Research - Cincinnati
🇺🇸Cincinnati, Ohio, United States
Velocity Clinical Research - Cleveland
🇺🇸Cleveland, Ohio, United States
Hatboro Medical Associates/ CCT Research
🇺🇸Hatboro, Pennsylvania, United States
Mercado Medical Practice / CCT Research
🇺🇸Philadelphia, Pennsylvania, United States
Palmetto Clinical Reserach
🇺🇸Summerville, South Carolina, United States
Velocity Clinical Research - Union
🇺🇸Union, South Carolina, United States
Apex Mobile Clinical Research
🇺🇸Bellaire, Texas, United States
Pinnacle Clinical Research - San Antonio
🇺🇸San Antonio, Texas, United States
Ogden Clinic, Mount View/CCT Research
🇺🇸Pleasant View, Utah, United States
Velocity Clinical Research - Salt Lake City
🇺🇸Salt Lake City, Utah, United States