A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia (SOLARIS-1)

Lilly

Status and phase: Not yet enrolling; Phase 2

Conditions: Severe Hypertriglyceridemia

Treatments: Drug: Placebo; Drug: Solbinsiran

Study type: Interventional

Funder types: Industry

Identifiers

NCT07269210

27775

J3F-MC-EZCC (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of solbinsiran in lowering triglycerides and other lipid measures compared to placebo in participants with severe hypertriglyceridemia. Participants will receive two subcutaneous injections.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• History of fasting triglyceride levels of ≥500 milligrams per deciliter (mg/dL), based on medical history
• Fasting triglyceride level ≥500 mg/dL at two separate visits during screening (at least 7 days apart)
• Have a body mass index (BMI) within the range of 18.5 to 45.0 kilograms per square meter (kg/m2) (inclusive)

Exclusion criteria

• Have had a major atherosclerotic cardiovascular event within the past 3 months prior to screening
• Have a history of acute pancreatitis within 12 months prior to screening
• Have a known genetically confirmed diagnosis of Familial Chylomicronemia Syndrome
• Have a history of or planned treatment involving any gene editing or gene therapy modalities, including but not limited to CRISPR-based, viral vector-mediated, or other genetic modification techniques
• Have a history of chronic alcohol abuse within 3 years prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups, including a placebo group

Solbinsiran

Experimental group

Description:

Participants will receive solbinsiran subcutaneously (SC)

Treatment:

Drug: Solbinsiran

Placebo

Placebo Comparator group

Description:

Participants will receive placebo SC

Treatment:

Drug: Placebo