Hypertriglyceridemia (HTG) is a common form of a lipid disorder with a fasting plasma triglyceride (TG) above 150 mg/dL. Patients with severe hypertriglyceridemia (SHTG) have triglyceride levels more than three times the normal level,i.e. >500 mg/dL. SHTG may result from primary (genetic defects in triglyceride metabolism) or secondary causes, including uncontrolled type 2 diabetes mellitus (T2DM), obesity, and sedentary habits. SHTG can lead to multiple serious conditions such as cardiovascular disease (CVD), acute pancreatitis and diabetic ketoacidosis.
The general treatment regimen for SHTG includes dietary restrictions and lipid-lowering drugs such as fibrates, omega-3-fatty acids, and nicotinic acid. The rise in the incidence of SHTG is associated with the increasing prevalence of T2DM, therefore, a therapeutic agent that can address both T2DM and SHTG with additional beneficial effects on lipids and body weight may represent the ‘next generation’ TG lowering agent.
Beneficial effects of HTD1801 in SHTG are expected to include:
In preclinical hamster NASH/HTG model, HTD1801 significantly lowered serum triglycerides in hamsters after 6 weeks of treatment
In NASH Phase 2a clinical trial, HTD1801 significantly lowered triglycerides and LDL-C of patients after 18 weeks of treatment
According tothe consulting firm CIC:
● The total diagnosed prevalent cases of Severe Hypertriglyceridemia (SHTG) in China, the United States and Europe are 2739.2 thousand patients in 2022.
● Fibrates, fish oil, and niacin are the main pharmacologic agents for managing SHTG, each with its own limitations.
● There remains a medical need for safe and effective therapies for the treatment of adult patients with SHTG, therapies that address not only triglyceride levels but also comorbid conditions.