SOLARIS-1

Summary

Triglycerides belong to the group of nutrients known as lipids, which are the building blocks of fat. Healthy amounts of fat are used to store and transport energy throughout the body.

However, unhealthily high levels of triglycerides lead to excess fat, increasing the risks of heart disease and hardening or narrowing of the arteries (atherosclerosis). What’s more, high blood triglyceride levels often have few warning signs, until they cause a severe event such as a heart attack or stroke.

 The new drug evaluated in SOLARIS-1 (solbinsiran) is designed to block the conversion of triglycerides to fat, thereby decreasing triglycerides and other lipids among adults with severely high blood levels of these compounds.

 While continuing their current treatment plan, participants in SOLARIS-1 will be assigned randomly (50-50, like a coin toss) to also receive either the study drug or something that looks like it but doesn't contain any medicine (placebo). Neither the lead scientist nor the participant will know or can choose which group they are in. Both the drug and the placebo are injected into the skin. A person’s involvement in SOLARIS-1 will last about 48 weeks and may include up to 12 clinic visits.

To be included in SOLARIS-1, participants must be / have

• A medical history of fasting triglyceride levels of ≥500 mg/dL
• A fasting triglyceride level of ≥500 mg/dL at two separate visits (at least 7 days apart) during the study screening period
• A body mass index (BMI) of 18.5 to 45.0 kg/m²

To be included in SOLARIS-1, participants must not be / have

• A major atherosclerotic cardiovascular event (for example, stroke, heart attack, heart catheterization procedure) within 3 months prior to screening
• Acute pancreatitis within 12 months prior to screening
• A history of chronic alcohol abuse within 3 years prior to screening

Keywords
EZCC; High cholesterol; High triglycerides; Hypertriglyceridemia