臨床研究等提出・公開システム

Date of registration	Dec. 15, 2025
Last modified on	Oct. 14, 2026
Trial ID	jRCT2031250567

Scientific Title	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)
Public Title	A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia (J3F-MC-EZCC)

Contact for Scientific Queries	Name	Masaki Takeshi
	Affiliation	Eli Lilly Japan K.K.
	Address	5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo
	Telephone	+81-120-023-812
	E-mail	LTG_CallCenter@lists.lilly.com
Contact for Public Queries	Name	Trial Guide Call Center
	Affiliation	Eli Lilly Japan K.K.
	Address	5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo
	Telephone	+81-120-023-812
	E-mail	LTG_CallCenter@lists.lilly.com

Recruitment status	Not Recruiting

Anticipated date of first enrollment		Jan. 16, 2026
Target sample size		60
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion 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	- 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
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Severe Hypertriglyceridemia
Intervention(s)		DRUG: Solbinsiran(Other Name: LY3561774) Administered SC DRUG: Placebo Administered SC (Study Arms) Experimental: Solbinsiran Participants will receive solbinsiran subcutaneously (SC) Interventions: Drug: Solbinsiran Placebo Comparator: Placebo Participants will receive placebo SC Interventions: Drug: Placebo
Primary Outcome(s)		Change from Baseline in Triglycerides [ Time Frame: Baseline, Weeks 16-24 (Time-Average)

Primary Sponsor	Eli Lilly Japan K.K.

Name of Certified Review Board	Review Board of Human Rights and Ethics for Clinical Studies
Address	2-2-1 Kyobashi, Chuo-ku, Tokyo, Tokyo
Telephone	+81-3-5213-0028
E-Mail	soudan@hurecs.org
Approval Status	Approval
Date of approval	Nov. 10, 2025

Plan to share IPD	Yes
Plan description	Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Secondary ID(s)	NCT07269210
Issuing Authority	ClinicalTrial.gov

Countries of Recruitment（Except Japan）	United States/Canada/China

History of Changes

No	Publication date
3	Oct. 14, 2026	(this page)	Changes
2	Feb. 24, 2026	Detail	Changes
1	Dec. 15, 2025	Detail

List of change history