AzTrials
AzTrials

High TriglyceridesPhase 2NCT05889156

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

A Phase 2 study testing NST-1024 in people with High Triglycerides, run by NorthSea Therapeutics B.V. at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 79 years
Conditions the study is for
High Triglycerides
What is being tested?
NST-1024
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
31 sitesUnited States
Study dates
30 Jun 2023to 11 Apr 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 79 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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.

Who cannot join

  • 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.
Show all 36Show fewer
  • 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;
  • History of malignancy, unless:
  • All treatment for the malignancy was completed ≥2 years prior to screening and there is no evidence of disease; II. Curatively resected squamous or basal cell carcinomas of the skin, carcinomas in situ of the cervix or uterus, ductal breast cancer in situ or low-grade prostate cancer III. Squamous cell or basal cell skin carcinomas that are not requiring tumour directed treatment during the subject's participation in the study
  • History of bariatric surgery less than 2 years prior to randomization. A history of bariatric surgery utilizing the gastric bypass technique (Roux-en-Y) or biliopancreatic diversion with duodenal switch is exclusionary;
  • Uncontrolled hypertension;
  • Known to be infected with human immunodeficiency virus (HIV) AND who are not on stable antiretroviral therapy OR have a confirmed plasma HIV-1 RNA (Viral Load) > lower limit of detection despite antiretroviral therapy OR have a CD4+ T-cell count <350 cell/μL OR a history of acquired immunodeficiency syndrome(AIDS);
  • Hepatitis B or C:
  • Acute or chronic Hepatitis B infection based on a positive hepatitis B surface antigen (HBsAg) test at screening (Visit 1 [Week -3]). Subjects with a past hepatitis B virus (HBV) infection or resolved HBV infection (defined by presence of hepatitis B core antibody (HBcAb) and absence of HbsAg are eligible if confirmed with negative HBV DNA test performed at screening; II. Positive test for hepatitis C antibody at screening (Visit 1 [Week -3]), except for those who have been successfully treated for hepatitis C infection and have achieved sustained virologic response for ≥1 year and who have a negative reflex HCV RNA test;
  • Anticipation of major surgery during the screening or double-blind treatment periods of the study;
  • Treatment with chronic prescription pharmacotherapy for metabolic or CV disease management or risk factor modification (e.g., antihypertensive and antidiabetic medications) that has not been stable for ≥28 days prior to screening (Visit 1 [Week -3]);
  • Ongoing treatment with cyclophosphamide (unless chronic oral administration for inflammatory conditions such as rheumatoid arthritis or inflammatory bowel disease), or isotretinoin;
  • Treatment with tamoxifen, estrogens, or progestins that has not been stable for ≥28 days prior to screening (Visit 1 [Week -3]);
  • Use of systemic corticosteroids at a dose >7.5mg daily prednisolone equivalent (per Appendix A) ≤28 days prior to screening or anticipated use during study. Use of local injectable, inhaled, nasal administration, topical corticosteroids, or low dose glucocorticoids (≤7.5 mg prednisolone equivalent) is permitted. Low dose oral glucocorticoids should have been used for ≥ 3 months and stable for ≥ 28 days prior to baseline (Visit 3);
  • Thyroid-stimulating hormone (TSH) > 2.0 x upper limit of normal (ULN), clinical evidence of hypothyroidism, or thyroid hormone therapy that has not been stable for ≥6 weeks prior to screening (Visit 1 [Week -3]);
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2.5 x ULN, unless exercise-related;
  • Unexplained CK concentration >5 × ULN or CK elevation due to known muscle disease (e.g., polymyositis, mitochondrial dysfunction);
  • Other recent or current serious disease that may interfere with the conduct of the study (renal, ophthalmic, pulmonary, hepatic, biliary, gastrointestinal, mental disorder, infectious disease, or cancer);
  • Blood donation of ≥1 pint (0.5 L) within 8 weeks prior to screening (Visit 1 [Week -3]) or anticipated blood donation during study, or plasma donation within 7 days prior to screening (Visit 1 [Week -3]);
  • History of illicit drug use or alcohol abuse within 1 year of screening (Visit 1 [Week -3]). Alcohol abuse is defined as >21 standard drinks per week in men and >14 standard drinks per week in women, on average;
  • Any condition or therapy, which, in the opinion of the investigator, might pose a risk to the subject or make participation in the study not in the subject's best interest;
  • Poor mental function or any other reason to expect subject difficulty in complying with the requirements of the study; or in the investigator's opinion, not able to comply with study procedures.
  • Pregnancy or breastfeeding.

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites

  • Lynn Institute of Denver

    Aurora, Colorado, 80012

  • Apex Mobile Clinical Research

    Bellaire, Texas, 77401

  • Cenexel HRI

    Berlin, New Jersey, 08009

  • University of Alabama - Heersink School of Medicine

    Birmingham, Alabama, 35487

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio, 45242

  • Velocity Clinical Research - Cleveland

    Cleveland, Ohio, 44122

  • Alliance for Multispecialty Research, LLC (AMR) - Daphne

    Daphne, Alabama, 36526

  • Velocity Clinical Research, New Smyrna Beach

    Edgewater, Florida, 32132

  • Deaconess Clinic - Indiana

    Evansville, Indiana, 47712

  • Hatboro Medical Associates/ CCT Research

    Hatboro, Pennsylvania, 19040

  • Clay Platte Family Medicine / CCT Research

    Kansas City, Missouri, 64116

  • Velocity Clinical Research, San Diego

    La Mesa, California, 91942

  • Clearwater Cardiovascular Consultants

    Largo, Florida, 33756

  • Lifeline Primary Care/ CCT Research

    Lilburn, Georgia, 30047

  • Velocity Clinical Research - Kearney

    Lincoln, Nebraska, 68506

  • University of Louisville - UoL Physicians Outpatient Center

    Louisville, Kentucky, 40292

  • Velocity Clinical Research - Boise

    Meridian, Idaho, 83642

  • Floridian Clinical Research

    Miami Lakes, Florida, 33014

  • Alliance for Multispecialty Research, LLC (AMR) - Newton

    Newton, Kansas, 67114

  • Velocity Clinical Research, North Hollywood

    North Hollywood, California, 91605

  • Mercado Medical Practice / CCT Research

    Philadelphia, Pennsylvania, 19111

  • Ogden Clinic, Mount View/CCT Research

    Pleasant View, Utah, 84414

  • Velocity Clinical Research - Salt Lake City

    Salt Lake City, Utah, 84088

  • Pinnacle Clinical Research - San Antonio

    San Antonio, Texas, 78229

  • Velocity Clinical Research - Costal Heart

    Santa Ana, California, 92704

  • Palmetto Clinical Reserach

    Summerville, South Carolina, 29456

  • Alliance for Multispecialty Research, LLC (AMR) - Phoenix

    Tempe, Arizona, 85281

  • Troy Internal Medicine

    Troy, Michigan, 48098

  • Velocity Clinical Research - Union

    Union, South Carolina, 29379

  • Velocity Clinical Research, Valparaiso

    Valparaiso, Indiana, 46383

  • Metabolic Research Institute, Inc.

    West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: 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

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.

Being tested
NST-1024, Placebo
Medical subject headings
Hypertriglyceridemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NST-1024Drug

    400 mg BID

  • PlaceboOther

    matched placebo to active arm

Study groups in NCT05889156
Study groupRoleWhat they receive
Matched PlaceboPlacebo comparatorNot described
Receives: Other: Placebo
NST-1024Active comparatorNST-1024 400 mg BID
Receives: Drug: NST-1024

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 4 weeks

Secondary outcomes (9)

  1. Percent Change in Cholesterol Values

    Percent changes in TC, HDL-C, LDL-C, calculated. non-HDL-C, and VLDL-C from baseline to Week 4

    Measured: 4 weeks

  2. Percent change in Apolipoprotein B and Apolipoprotein C3

    Percent changes in ApoB and ApoC3 from baseline to Week 4.

    Measured: 4 weeks

  3. Percent Change in Lipoprotein a

    Percent change in Lp(a) from baseline to Week 4.

    Measured: 4 weeks

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

    Percent Change in RLP-C from baseline to Week 4.

    Measured: 4 weeks

  5. Changes in fasting plasma glucose, fasting plasma insulin, and HbA1c

    Changes in fasting plasma glucose (FPG), fasting plasma insulin (FPI) and HbA1c from baseline to Week 4

    Measured: 4 weeks

  6. Change in insulin resistance.

    Change in insulin resistance, as assessed by the homeostasis model index insulin resistance, from baseline to Week 4

    Measured: 4 weeks

  7. Change in lipoprotein associated phospholipase A2

    Percent change in lipoprotein associated phospholipase A2 from baseline to Week 4

    Measured: 4 weeks

  8. Change in hsCRP

    Change in hsCRP from baseline to Week 4

    Measured: 4 weeks

  9. Safety Assessments

    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.

    Measured: ~ 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jun 2023
  2. Study start30 Jun 2023
  3. Primary completion18 Mar 2025
  4. Study completion11 Apr 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05889156
Sponsor's protocol ID
NST-1024-03
Status last verified
Apr 2025
First submitted
16 Mar 2023
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Kastelein JJ, Skjaeret T, Jeannin S, Beyusen R, Fraser DA, Maki KC. NST-1024 for the treatment of very high triglycerides: A placebo-controlled, randomized, double-blind, 28-day clinical trial. J Clin Lipidol. 2026 Sep 29:S1933-2874(26)00530-1. doi: 10.1016/j.jacl.2026.09.016. Online ahead of print.

    PubMed 42838769

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing NST-1024 in people with High Triglycerides, run by NorthSea Therapeutics B.V. at 31 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the efficacy of NST-1024 by percentage change in TG (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05889156, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in