Recruiting
Phase 2

Solbinsiran

Sponsor:

Eli Lilly and Company

Code:

NCT07269210

Conditions

Severe Hypertriglyceridemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Solbinsiran

Placebo

Study Details

Brief summary:

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.

Conditions

Severe Hypertriglyceridemia

Study ID

NCT07269210

Start date

Dec 8, 2025

Status verified date

Oct, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Solbinsiran

Participants will receive solbinsiran subcutaneously (SC)

placebo comparator: Placebo

Participants will receive placebo SC

Interventions

Solbinsiran

Administered SC

Placebo

Administered SC

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Ecogene-21

Recruiting

Chicoutimi, Canada, G7H 7K9

Contacts

418-545-1252

Principal Investigator:

Daniel Gaudet

C.I.C. Mauricie inc.

Recruiting

Trois-Rivières, Canada, G8T 7A1

Contacts

8193731128

Principal Investigator:

Imen Mekrazi

ARC Biosystems

Recruiting

Vancouver, Canada, V6Z 2H2

Principal Investigator:

Liam Brunham

More Information

Sponsor

Eli Lilly and Company

Last update posted

Oct 8, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.