A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia
A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY3202328
2 other identifiers
interventional
60
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Mar 2016
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 16, 2016
CompletedFirst Posted
Study publicly available on registry
March 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2017
CompletedResults Posted
Study results publicly available
May 25, 2021
CompletedMay 25, 2021
May 1, 2021
12 months
March 16, 2016
March 22, 2021
May 3, 2021
Conditions
Outcome Measures
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
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.
Baseline, Up to 42 Days
Secondary Outcomes (18)
Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose
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
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
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
Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A
Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose
- +13 more secondary outcomes
Study Arms (4)
Part A: LY3202328 (LY)
EXPERIMENTALSingle 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.
Part A: Placebo
PLACEBO COMPARATORA single ascending dose of placebo orally, in 1 period while fasting, and up to one period while fed.
Part B: LY3202328 (LY)
EXPERIMENTALA 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.
Part B: Placebo
PLACEBO COMPARATORA 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Clinical Pharmacology of Miami, Inc.
Miami, Florida, 33014, United States
PRA Health Sciences
Lenexa, Kansas, 06219, United States
PRA Health Sciences
Marlton, New Jersey, 08053, United States
PRA Health Sciences
Salt Lake City, Utah, 84106, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2016
First Posted
March 21, 2016
Study Start
March 1, 2016
Primary Completion
February 15, 2017
Study Completion
February 15, 2017
Last Updated
May 25, 2021
Results First Posted
May 25, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share