A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia

Eli Lilly and Company60 enrolled

Overview

The purpose of this two-part study is to evaluate the safety and tolerability of the study drug known as LY3202328 in healthy overweight participants in Part A, and those with dyslipidemia (abnormal blood fats) in Part B.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Dyslipidemias

Interventions

LY3202328DRUG

Administered orally

PlaceboDRUG

Administered orally

AtorvastatinDRUG

Administered orally

Simvastatin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Be healthy, as determined by medical history and physical examination * Male participants must be between 18 and 70 years of age and must agree to use a reliable method of birth control during the study and 3 months following the last dose of the investigational product * Female participants must be between 40 and 70 years old, and either postmenopausal or with a hysterectomy, and not pregnant and not lactating * Be on a stable diet and exercise regimen for greater than (\>) 3 months prior * Have a body mass index (BMI) of 25.0 to 35.0 (Part A) or 27.0 to 40.0 (Part B) kilograms per meter squared * Have fasting triglycerides (TG) between 150 and 499 milligrams per deciliter (mg/dL) (Part B only) * Have a fasting low-density lipoprotein cholesterol (LDL-c) between 100 and 200 mg/dL (Part B only) * Have estimated glomerular filtration rate greater than or equal to (≥) 60 milliliters per minute/1.73 meter squared with no proteinuria * Be normotensive defined as supine systolic blood pressure (BP) less than or equal to (≤) 150 millimeters of mercury (mm Hg) and diastolic BP ≤ 100 mm Hg, without the use of any antihypertensive Exclusion Criteria: * Are taking a statin, any proprotein convertase subtilisin/kexin type 9 (PCSK9) medications, or have started taking other TG lowering agents (for example, niacin, fish oils) * Are currently enrolled in a clinical trial involving an investigational product or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research, or have participated in a clinical trial involving an investigational product or non-approved use of a drug within the last 30 days or within 5 half-lives * Have an abnormal electrocardiogram or corrected QT or are on antihypertensive treatment * Have any current or prior history of significant cardiovascular disease * Show evidence of hepatitis C virus (HCV), Hepatitis B or other chronic liver disease * Have an alcohol intake that exceeds 7 units per week with no more than 3 units per day, or are unwilling to stop alcohol consumption for the duration of the study (1 unit = 12 ounces or 360 mL of beer; 5 ounces or 150 mL of wine; 1.5 ounces or 45 mL of distilled spirits), or are a regular user of known drugs of abuse * Have a history of untreated endocrine illness such as diabetes mellitus * Have been on medications or supplements for weight loss within 3 months * Have a history of active neuropsychiatric disease or on pharmacological therapy for such conditions (Part B, only) * Show evidence of human immunodeficiency virus (HIV) infection * Have been on medications that are known to inhibit cytochrome P450, family 3, subfamily A (CYP3A) or P-glycoprotein (P-gp), or regularly consume grapefruit * Have donated blood of more than 500 mL within the last month * Smoke \>10 cigarettes per day or are unwilling to follow smoking rules

Locations (4)

Clinical Pharmacology of Miami, Inc.

Miami, Florida, United States

PRA Health Sciences

Lenexa, Kansas, United States

PRA Health Sciences

Marlton, New Jersey, United States

PRA Health Sciences

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration Part A and Part B

Number of participants with one or more SAEs in Part A and Part B. A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section.

Time frame: Baseline, Up to 42 Days

Secondary Outcomes

Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose

Pharmacokinetics (PK) is the maximum plasma concentration (Cmax) of LY3202328 Part A after a single dose.

Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose

PK: Steady State Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part B

PK is the maximum plasma concentration of LY3202328 (Cmax) at steady state in Part B.

Time frame: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose

PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose

PK is the area under the serum concentration time curve from zero to Infinity (AUC\[0-∞\]) of LY3202328 in Part A after a single dose.

Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose

PK: Steady State Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCτ) of LY3202328 (LY) in Part B

PK is the area under the serum concentration-time curve (AUCτ) of LY3202328 at steady state during the dosing interval in Part B.

Time frame: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose

Data from ClinicalTrials.gov

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