Phase 1
N=18
A Study to Evaluate LY3202328 in Overweight Healthy Participants and Dyslipidemia
Dyslipidemias
Bottom Line
View on ClinicalTrials.gov: NCT02714569 ↗Enrolled (actual)
18
Serious AEs
2.0%
Results posted
May 2021
Primary outcome: Primary: 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 — 0; 0; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LY3202328 (Drug); Placebo (Drug); Atorvastatin (Drug); Simvastatin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Feb 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Pharmacokinetics (PK): Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part A After a Single Dose |
48.258; 105.023; 340.829; 581.782; 1600.953; 1632.595 | — |
| SECONDARY PK: Steady State Maximum Plasma Concentration (Cmax) of LY3202328 (LY) in Part B |
445.858; 882.125; 3687.167; 3209.396 | — |
| SECONDARY PK: Area Under the Serum Concentration Time Curve From Zero to Infinity (AUC[0-∞]) of LY3202328 (LY) in Part A After a Single Dose |
NA; NA; 7726.17; 17018.43; 55406.24; 66185.70 | — |
| SECONDARY PK: Steady State Area Under the Serum Concentration-Time Curve During the Dosing Interval (AUCτ) of LY3202328 (LY) in Part B |
7587.24; 13362.44; 67499.80; 50774.85 | — |
| SECONDARY PK: Time to Maximum Concentration (Tmax) of LY3202328 (LY) in Part A |
2.02; 3.52; 4.0; 4.00; 6.00; 4.02 | — |
| SECONDARY PK: Steady State Tmax of LY3202328 (LY) in Part B |
2.00; 4.20; 3.00; 3.04 | — |
| SECONDARY Pharmacodynamics (PD): Change From Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A |
-0.003; -0.030; -0.043; -0.047; -0.026; 0.052 | — |
| SECONDARY PD: Change From Baseline to Last Day of Dosing in Fasting HDL-c in Part B |
0.008; -0.010; -0.101; -0.107; -0.101 | — |
| SECONDARY PD: Change From Baseline in Fasting Total Triglycerides Part A |
-0.276; -0.397; -0.190; -0.386; -0.311; -0.523 | — |
| SECONDARY PD: Change From Baseline to Last Day of Dosing in Fasting Total Triglycerides in Part B |
0.205; -0.131; -0.231; 0.020; -0.480 | — |
| SECONDARY PD: Change From Baseline to in Fasting Total Cholesterol in Part A |
0.085; -0.186; -0.013; -0.203; 0.073; 0.285 | — |
| SECONDARY PD: Change From Baseline to Last Day of Dosing in Fasting Total Cholesterol in Part B |
0.206; 0.118; 0.183; 0.174; -0.190 | — |
| SECONDARY PD: Change From Baseline in Fasting Low-Density Lipoprotein Cholesterol (LDL-c) in Part A |
0.231; 0.025; 0.117; 0.020; 0.241; 0.471 | — |
| SECONDARY PD: Change From Baseline to Last Day of Dosing in Fasting LDL-c in Part B |
0.103; 0.184; 0.388; 0.227; 0.131 | — |
| SECONDARY PK: Cmax of Simvastatin With/Without LY3202328 (LY) in Part B |
2.906; 2.061; 2.388; 3.374; 3.576; 3.274 | — |
| SECONDARY PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin With/Without LY3202328 (LY) in Part B |
9.648; 6.250; 6.668; 9.287; 9.697; 7.960 | — |
| SECONDARY PK: Cmax of Atorvastatin With/Without LY3202328 (LY) in Part B |
3.479; 3.575; 2.840; 3.621; 1.238; 1.286 | — |
| SECONDARY PK: AUC (0-t) of Atorvastatin With/Without LY3202328 (LY) in Part B |
15.874; 16.518; 17.311; 14.913; 7.921; 7.952 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02714569). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.