A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2017-02-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Part A is a crossover. Part B is a parallel assignment.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: LY3202328 (LY)

Single ascending doses of 1 milligram (mg), 3 mg, 10 mg, 30 mg, 100 mg, 300mg, 600 mg LY3202328 orally while fasting, or 30 mg LY3202328 orally while fed in 4 periods.

Group Type EXPERIMENTAL

LY3202328

Intervention Type DRUG

Administered orally

Part A: Placebo

A single ascending dose of placebo orally, in 1 period while fasting, and up to one period while fed.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Part B: LY3202328 (LY)

A multiple ascending dose of 5 mg, 20 mg, 100 mg, and 300 mg LY3202328 at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (atorvastatin or simvastatin) one week prior to treatment and on Day 29.

Group Type EXPERIMENTAL

LY3202328

Intervention Type DRUG

Administered orally

Atorvastatin

Intervention Type DRUG

Administered orally

Simvastatin

Intervention Type DRUG

Administered orally

Part B: Placebo

A multiple ascending dose of placebo at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of 10 mg statin (atorvastatin or simvastatin) one week prior to treatment and on Day 29.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Atorvastatin

Intervention Type DRUG

Administered orally

Simvastatin

Intervention Type DRUG

Administered orally

Interventions

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LY3202328

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Atorvastatin

Administered orally

Intervention Type DRUG

Simvastatin

Administered orally

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes