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

NCT05889156 | Completed Phase 2 FDA Drug

• 1 other identifier: NST-1024-03
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 31

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. 1.A 3-week screening period that includes a TG qualifying period, and
2. 2.A 28-days, double-blind, randomized, parallel group, placebo-controlled treatment period.

Conditions

High Triglycerides

Outcome Measures

Primary Outcomes (1)

• Evaluate the efficacy of NST-1024 by percentage change in TG

  Evaluate the efficacy of NST-1024 400 mg BID by assessment of the percentage change in TG from baseline after 28 days of treatment

  4 weeks

Secondary Outcomes (9)

• Percent Change in Cholesterol Values

  4 weeks

• Percent change in Apolipoprotein B and Apolipoprotein C3

  4 weeks

• Percent Change in Lipoprotein a

  4 weeks

• Percent Change in remnant-like particle cholesterol (RLP-C)

  4 weeks

• Changes in fasting plasma glucose, fasting plasma insulin, and HbA1c

  4 weeks

Study Arms (2)

Matched Placebo

PLACEBO COMPARATOR

Other: Placebo

NST-1024

ACTIVE COMPARATOR

NST-1024 400 mg BID

Drug: NST-1024

Interventions

NST-1024 DRUG

400 mg BID

NST-1024

Placebo OTHER

matched placebo to active arm

Matched Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Understanding of the study procedures, willing to adhere to the study schedules, and agreement to participate in the study by giving written informed consent prior to screening (Visit 1 Week -3\]) assessments;
• Men or women 18 to 79 years of age, inclusive;
• If on statin or non-statin lipid-altering therapy, such as ezetimibe, niacin \>200 mg/day, bempedoic acid, fibrates, prescription omega-3 products, other consumer products containing omega-3 fatty acids, or other herbal products or dietary supplements with potential lipid and glucose-altering effects, subject's use must be stable for ≥28 days prior to the first TG baseline qualifying measurement (i.e., Visit 1 \[Week -3\]), and should remain stable thereafter for the duration of study participation;
• Fasting TG levels ≥500 mg/dL and ≤2000 mg/dL (based on an average \[arithmetic mean\] of Visit 1 and Visit 2). Note: In cases in which a subject's average TG level from Visit 1 and Visit 2 falls outside the range for entry into the study, an additional visit (Visit 2a) can be arranged up to 7 days after Visit 2 for an additional measurement of fasting TG levels. If a third sample is collected, entry into the double-blind treatment period will be based on the average of the highest TG value from Visit 1 and 2 and the Visit 2a value. Neither one of the two values used for the arithmetic mean can be less than 400 mg/dL;
• If using oral or injectable weight loss drug, subjects must maintain stable dose of all oral and injectable weight loss drugs (e.g., GLP-1 receptor agonists) for at least 3 months prior to screening (i.e., Visit 1 \[Week -3\]), and during participation in the study.
• Willingness to maintain stable diet and physical activity level throughout the study
• If a smoker, no plans to change smoking habits during the study period.
• Agree to use appropriate contraceptive methods based on biological sex and child-bearing potential as outlined in Section 12.5 of the protocol.
• Agree to abstain from sperm or egg donation through 90 or 30 days, respectively, after administration of the last dose of IP.

You may not qualify if:

• Body mass index \>50 kg/m2;
• Participation in another clinical study involving an investigational agent within 30 days prior to screening or 5½ half-lives whichever is longer (Visit 1 \[Week -3\]);
• Type 1 diabetes mellitus;
• HbA1c \> 9.5% at screening (Visit 1 \[Week -3\]);
• History of stroke, myocardial infarction, life-threatening arrhythmia, or coronary revascularization within 6 months prior to screening;
• History of chronic pancreatitis or acute pancreatitis in the last year. Subjects at risk of developing pancreatitis (e.g., known cholelithiasis, known alcohol abuse or multiple incidences of acute pancreatitis) per the PI's assessment are excluded. Subjects with a history of acute pancreatitis due to gallstones who have been treated with cholecystectomy are allowed.
• History of symptomatic gallstone disease unless treated with cholecystectomy;
• History of nephrotic range (\>3 g/day) proteinuria;
• Estimated glomerular filtration rate (eGFR) \< 45 mL/min/1.73 m2
• QTcF interval of \>450ms for males or \>470ms for females
• A history of additional risk factors for torsades de pointes (TdP) (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
• The use of concomitant medications that prolong the QT/QTc interval (Table 1);
• History or evidence of major and clinically significant hepatic, pulmonary, renal, hematologic, gastrointestinal (including clinically significant malabsorption), endocrine, immunologic, dermatologic, neurologic, psychiatric, oncologic, or allergic (including drug allergies, but excluding untreated or treated seasonal allergies at the time of dosing) disease that would interfere with the conduct of the study or interpretation of the data;
• Known lipoprotein lipase impairment or deficiency (Fredrickson Type I), apolipoprotein C-II deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III);
• Requirement for peritoneal dialysis or haemodialysis for renal insufficiency;

Sponsors & Collaborators

• NorthSea Therapeutics B.V.: lead

Study Sites (31)

University of Alabama - Heersink School of Medicine

Birmingham, Alabama, 35487, United States

Location

Alliance for Multispecialty Research, LLC (AMR) - Daphne

Daphne, Alabama, 36526, United States

Location

Alliance for Multispecialty Research, LLC (AMR) - Phoenix

Tempe, Arizona, 85281, United States

Location

Velocity Clinical Research, San Diego

La Mesa, California, 91942, United States

Location

Velocity Clinical Research, North Hollywood

North Hollywood, California, 91605, United States

Location

Velocity Clinical Research - Costal Heart

Santa Ana, California, 92704, United States

Location

Lynn Institute of Denver

Aurora, Colorado, 80012, United States

Location

Velocity Clinical Research, New Smyrna Beach

Edgewater, Florida, 32132, United States

Location

Clearwater Cardiovascular Consultants

Largo, Florida, 33756, United States

Location

Floridian Clinical Research

Miami Lakes, Florida, 33014, United States

Location

Metabolic Research Institute, Inc.

West Palm Beach, Florida, 33401, United States

Location

Lifeline Primary Care/ CCT Research

Lilburn, Georgia, 30047, United States

Location

Velocity Clinical Research - Boise

Meridian, Idaho, 83642, United States

Location

Deaconess Clinic - Indiana

Evansville, Indiana, 47712, United States

Location

Velocity Clinical Research, Valparaiso

Valparaiso, Indiana, 46383, United States

Location

Alliance for Multispecialty Research, LLC (AMR) - Newton

Newton, Kansas, 67114, United States

Location

University of Louisville - UoL Physicians Outpatient Center

Louisville, Kentucky, 40292, United States

Location

Troy Internal Medicine

Troy, Michigan, 48098, United States

Location

Clay Platte Family Medicine / CCT Research

Kansas City, Missouri, 64116, United States

Location

Velocity Clinical Research - Kearney

Lincoln, Nebraska, 68506, United States

Location

Cenexel HRI

Berlin, New Jersey, 08009, United States

Location

Velocity Clinical Research - Cincinnati

Cincinnati, Ohio, 45242, United States

Location

Velocity Clinical Research - Cleveland

Cleveland, Ohio, 44122, United States

Location

Hatboro Medical Associates/ CCT Research

Hatboro, Pennsylvania, 19040, United States

Location

Mercado Medical Practice / CCT Research

Philadelphia, Pennsylvania, 19111, United States

Location

Palmetto Clinical Reserach

Summerville, South Carolina, 29456, United States

Location

Velocity Clinical Research - Union

Union, South Carolina, 29379, United States

Location

Apex Mobile Clinical Research

Bellaire, Texas, 77401, United States

Location

Pinnacle Clinical Research - San Antonio

San Antonio, Texas, 78229, United States

Location

Ogden Clinic, Mount View/CCT Research

Pleasant View, Utah, 84414, United States

Location

Velocity Clinical Research - Salt Lake City

Salt Lake City, Utah, 84088, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2023
• First Posted: June 5, 2023
• Study Start: June 30, 2023
• Primary Completion: March 18, 2025
• Study Completion: April 11, 2025
• Last Updated: April 24, 2025

Record last verified: 2025-04

Locations

US (31)