Dyslipidemias Trial in United States (LY3475766 - IV, LY3475766 - SC, Placebo - IV) (2024)

Study Description

Brief Summary

This study will evaluate the safety and tolerability of LY3475766 when given to participantswith high levels of blood fat called triglycerides. It will also investigate how the bodyprocesses the study drug and the effect of the study drug on the body. Information about anyside effects will be documented. This study will last up to 16 weeks for each participant.

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline up to Day 85]

   A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

1. Pharmaco*kinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3475766 [Predose up to Day 85]

   PK: AUC of LY3475766

2. PK: Maximum Observed Drug Concentration (Cmax) of LY3475766 [Predose up to Day 85]

   PK: Cmax of LY3475766

3. PK: Time to Maximum Observed Drug Concentration (Tmax) of LY3475766 [Predose up to Day 85]

   PK: Tmax of LY3475766

4. Pharmacodynamics (PD): Percent Change from Baseline in Triglycerides (TG) [Baseline, Day 85]

   PD: Percent Change from Baseline in TG

5. PD: Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) [Baseline, Day 85]

   PD: Percent Change from Baseline in LDL-C

6. PD: Percent Change from Baseline in Apolipoprotein B (ApoB) [Baseline, Day 85]

   PD: Percent Change from Baseline in ApoB

Eligibility Criteria

Criteria

Inclusion Criteria:

• Are overtly healthy males or females, apart from dyslipidemia

• Male participants must agree to adhere to contraception restrictions

• Female participants must be of nonchildbearing potential and include those who areinfertile due to surgical sterilization or those who are postmenopausal

• Have a body mass index (BMI) >18.5 and <40 kilograms per meter squared (kg/m²)

• Have clinical laboratory test results within normal reference range, or acceptabledeviations per investigator discretion

• Have a fasting triglyceride (TG) level that is 135 to 499 milligrams per deciliter(mg/dL), inclusive, at both screening and Day -1

• Have a fasting low density lipoprotein cholesterol (LDL-C) level greater than or equalto (≥) 70 mg/dL, inclusive, at screening and Day -1

• Have had a stable body weight for the 3 months prior to randomization (<5% body weightchange)

• Have not modified diet or adopted any nutritional lifestyle modification within 3months prior to randomization

Exclusion Criteria:

• Are taking or have started taking Proprotein convertase subtilisin/kexin type 9(PCSK9) inhibitors within 3 months prior to randomization; or statins, fibrates, orniacin ≤1000 mg/day within 8 weeks prior to randomization; or niacin >1000 milligramsper day (mg/day) within 16 weeks prior to randomization; or any other lipid-loweringagents within 1 month prior to randomization

• Are taking or have started taking a beta-blocker, antiarrhythmic, non-dihydropyridinecalcium channel blocker, ivabradine, or any other heart rate lowering agent within 1month or 5 half-lives prior to randomization, whichever is longer

• Have a diagnosis of diabetes mellitus (type 1 diabetes mellitus or type 2 diabetesmellitus) or have 1 of the following at screening: fasting plasma glucoseconcentration ≥126 mg/dL (7.0 millimoles per liter [mmol/L]) OR a glycated hemoglobinlevel ≥6.5% (48 millimoles per mole [mmol/mol])

• Have previously completed or withdrawn from this study or any other studyinvestigating LY3475766, and have previously received the investigational product

• Have known allergies to LY3475766, related compounds, or any components of theformulation, or history of significant atopy

• Have a seated heart rate ≤50 beats per minute

• Have clinically significant abnormal electrocardiogram (ECG) results constituting arisk while taking the investigational product, as determined by the investigator

• Have an abnormal blood pressure (BP) as determined by the investigator

Contacts and Locations

Locations

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

More Information

Publications