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

ConditionSevere Hypertriglyceridemia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Solbinsiran

    Drug

    Administered SC

  • Placebo

    Drug

    Administered SC

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: SolbinsiranExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change from Baseline in Triglycerides

Time frame
Baseline, Weeks 16-24 (Time-Average)

Secondary outcomes

1

Change from Baseline in Angiopoietin-like-3 (ANGPTL3)

Time frame
Baseline, Week 24
2

Change from Baseline in Very-Low-Density Lipoprotein-Cholesterol (VLDL-C)

Time frame
Baseline, Week 24
3

Change from Baseline in Non-High-Density Lipoprotein-Cholesterol (non-HDL-C)

Time frame
Baseline, Week 24
4

Pharmacokinetics (PK): Steady State Area Under the Concentration Curve from Hour 0 to Infinity (AUC 0-∞)

Time frame
Week 0: 0.5 hour (hr) and 4 to 9 hr postdose, Week 12: 24 to 36 hr postdose

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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