Study of MAR001 in Adults With Elevated Triglycerides and Remnant Cholesterol
Фаза 2 – изследване на ефективността и дозировката
Заболявания:
Hypertriglyceridemia
Спонсор: Marea Therapeutics
Налично на:
БГ
Обобщение
The primary objective of the study is to evaluate the effect of MAR001 compared to placebo on levels of the TG and RC in adults with elevated TG and RC.
Кой може да участва
Inclusion Criteria:
* Elevated fasting TGs and RC
* Elevated nonfasting TGs and RC
* Fasting LDL-C ≥ 50 mg/dL (≥ 1.29 mmol/L) and ≤ 130 mg/dL (≤ 3.36 mmol/L)
* Willingness to provide informed consent and comply with the intervention and all study assessments
* Stable diet for a minimum of 3 months prior to screening and with no plans to change diet through duration of study
* Stable drug regimen (if relevant) prior to screening visit and no planned changes during screening or trial participation
Exclusion Criteria:
* Acute or chronic liver disease
* TG concentration ≥880mg/dl
* History of type 1 diabetes mellitus or history of diabetic ketoacidosis
* Newly diagnosed T2DM
* Participants with known active hepatitis A, B, or C
* Uncontrolled hypothyroidism
* Any condition that prevents the participant from complying with study procedures