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

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of LY3561774 (Solbinsiran) in Adults With Severe Hypertriglyceridemia - J3F-MC-EZCC

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2031250567
Enrollment
60
Registered
2025-12-15
Start date
2026-01-16
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Hypertriglyceridemia

Interventions

DRUG: Solbinsiran(Other Name: LY3561774) Administered SC DRUG: Placebo Administered SC (Study Arms) Experimental: Solbinsiran Participants will receive solbinsiran subcutaneously (SC) Interve

Sponsors

Masaki Takeshi
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Change from Baseline in Triglycerides [ Time Frame: Baseline, Weeks 16-24 (Time-Average)

Countries

Canada, China, Japan, United States

Contacts

Public ContactTrial Guide Call Center

Eli Lilly Japan K.K.

LTG_CallCenter@lists.lilly.com+81-120-023-812

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026