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OpenTrials
Completed

NCT Number: NCT02714569

A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Pharmacology of Miami, Inc., Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3202328

Drug

Administered orally

Placebo

Drug

Administered orally

atorvastatin

Drug

Administered orally

simvastatin

Drug

Administered orally

Primary outcomes

  1. 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

    Time frame: Baseline, Up to 42 Days

    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.

Secondary outcomes

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

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

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

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

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

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

  3. PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) 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 is the area under the serum concentration time curve from zero to Infinity (AUC[0-∞]) of LY3202328 in Part A after a single dose.

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

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

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

  5. PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A

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

    PK is the time to maximum concentration (Tmax) of LY3202328 in Part A

  6. PK: Steady State Tmax of LY3202328 (LY) in Part B

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

    PK is the Tmax of LY3202328 at steady state in Part B.

  7. Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A

    Time frame: Predose, 24, 48, 96 Hours Postdose

    Pharmacodynamics (PD) is the change from Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A.

  8. PD: Change From Baseline to Last Day of Dosing in Fasting HDL-c in Part B

    Time frame: Predose, Days 7, 14, 21, and 28 Postdose

    PD is the change from baseline to last day of dosing in fasting HDL-c in Part B.

  9. PD: Change From Baseline in Fasting Total Triglycerides Part A

    Time frame: Predose, 24, 48, 96 Hours Postdose

    PD is the change from baseline in fasting total triglycerides in Part A.

  10. PD: Change From Baseline to Last Day of Dosing in Fasting Total Triglycerides in Part B

    Time frame: Predose, Days 7, 14, 21, and 28 Postdose

    PD is the change from baseline to last day of dosing in fasting total triglycerides in Part B.

  11. PD: Change From Baseline to in Fasting Total Cholesterol in Part A

    Time frame: Predose, 24, 28, 96 Hours Postdose

    PD is the change from baseline in fasting total cholesterol in Part A.

  12. PD: Change From Baseline to Last Day of Dosing in Fasting Total Cholesterol in Part B

    Time frame: Predose, Days 7, 14, 21, and 28 Postdose

    PD is the change from baseline to last day of dosing in fasting total cholesterol in Part B.

  13. PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A

    Time frame: Predose, 24, 48, 96 Hours Postdose

    PD is the change from baseline in fasting low-density lipoprotein cholesterol (LDL-c) Part A.

  14. PD: Change From Baseline to Last Day of Dosing in Fasting LDL-c in Part B

    Time frame: Predose, Days 7, 14, 21, and 28 Postdose

    PD is the change from baseline to last day of dosing in fasting LDL-c in Part B.

  15. PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B

    Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose

    PK: Cmax of Simvastatin with/without LY3202328 (LY) Co-administration in Part B.

  16. PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B

    Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose

    PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration.

  17. PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B

    Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose

    PK: Cmax of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B.

  18. PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B

    Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose

    PK: AUC (0-t) of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY3202328

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 21, 2016
Registry last updated
May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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