Study of the Efficacy and Safety of NST-1024 Versus Placebo in Subjects With Hypertriglyceridemia (NCT05889156) | Clinical Trial Compass
CompletedPhase 2
Study of the Efficacy and Safety of NST-1024 Versus Placebo in Subjects With Hypertriglyceridemia
United States50 participantsStarted 2023-06-30
Plain-language 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 15-35 centers in USA.
Who can participate
Age range18 Years – 79 Years
SexALL
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Inclusion criteria
✓. 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.
What they're measuring
1
Evaluate the efficacy of NST-1024 by percentage change in TG
✓. 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.
Exclusion criteria
✕. 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;