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A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714569
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : March 14, 2017
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dyslipidemias Drug: LY3202328 Drug: Placebo Drug: Atorvastatin Drug: Simvastatin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY3202328
Study Start Date : March 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: Part A: LY3202328
A single ascending dose of LY3202328 orally, in 2 periods while fasting, and up to one period while fed.
Drug: LY3202328
Administered orally

Placebo Comparator: Part A: Placebo
A single ascending dose of placebo orally, in 1 period while fasting, and up to one period while fed.
Drug: Placebo
Administered orally

Experimental: Part B: LY3202328
A multiple ascending dose of LY3202328 at up to 4 dose levels, orally, once daily for 29 days, while fasting and with a single dose of statin (atorvastatin or simvastatin) one week prior to treatment and on Day 29.
Drug: LY3202328
Administered orally

Drug: Atorvastatin
Administered orally

Drug: Simvastatin
Administered orally

Placebo Comparator: 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 statin (atorvastatin or simvastatin) one week prior to treatment and on Day 29.
Drug: Placebo
Administered orally

Drug: Atorvastatin
Administered orally

Drug: Simvastatin
Administered orally




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 [ Time Frame: Baseline up to 42 days ]

Secondary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) of LY3202328 [ Time Frame: Baseline up to 42 days ]
  2. Area Under the Serum Concentration time Curve (AUC) from Zero to Infinity of LY3202328 [ Time Frame: Day 1 ]
  3. Area Under the Serum Concentration-Time Curve (AUC tau) of LY3202328 [ Time Frame: Baseline up to 28 days ]
  4. Time to Maximum Concentration (Tmax) of LY3202328 [ Time Frame: Baseline up to 28 days ]
  5. Change from Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) [ Time Frame: Baseline, up to 28 days ]
  6. Change from Baseline in Fasting Total Triglycerides [ Time Frame: Baseline, up to 28 days ]
  7. Change from Baseline in Fasting Total Cholesterol [ Time Frame: Baseline, up to 28 days ]
  8. Change from Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) [ Time Frame: Baseline, up to 28 days ]
  9. Simvastatin Cmax in LY3202328 Co-administration [ Time Frame: Baseline up to 29 days ]
  10. Atorvastatin Cmax in LY3202328 Co-administration [ Time Frame: Baseline up to 29 days ]
  11. Simvastatin AUC 0-24 in LY3202328 Co-administration [ Time Frame: Baseline up to 29 days ]
  12. Atorvastatin AUC 0-24 in LY3202328 Co-administration [ Time Frame: Baseline up to 29 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Be healthy, as determined by medical history and physical examination
  • Male participants 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 (Part A) or 27.0 (Part B) to 40.0 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02714569


Locations
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United States, Florida
Clinical Pharmacology of Miami, Inc.
Miami, Florida, United States, 33014
United States, Kansas
PRA Health Sciences
Lenexa, Kansas, United States, 06219
United States, New Jersey
PRA Health Sciences
Marlton, New Jersey, United States, 08053
United States, Utah
PRA Health Sciences
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02714569    
Other Study ID Numbers: 16417
I8Q-MC-GSEA ( Other Identifier: Eli Lilly and Company )
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: March 14, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Atorvastatin
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors