A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia
Dyslipidemias
About this trial
This is an interventional basic science trial for Dyslipidemias
Eligibility Criteria
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
Sites / Locations
- Clinical Pharmacology of Miami, Inc.
- PRA Health Sciences
- PRA Health Sciences
- PRA Health Sciences
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Part A: LY3202328 (LY)
Part A: Placebo
Part B: LY3202328 (LY)
Part B: Placebo
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.
A single ascending dose of placebo orally, in 1 period while fasting, and up to one period while fed.
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.
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.