Dyslipidemias
Conditions
Brief summary
This is a 3-part study. In Parts A and B, the main purpose is to evaluate the safety and tolerability of the study drug known as LY3561774 in participants with dyslipidemia (high blood fat levels). How the body processes the study drug and the effect of the study drug on blood fat levels will also be investigated. Part C will mainly evaluate the safety and tolerability of LY3561774 as well as how the body processes the study drug in Japanese participants. The study may last up 52, 56 and 28 weeks for each participant in Parts A, B and C, respectively. There are up to 22, 26 and 16 visits in Parts A, B and C, respectively.
Interventions
DRUGLY3561774
Administered SC.
DRUGPlacebo
Administered SC.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* For Parts A and B, have a fasting triglyceride (TG) level greater than or equal to (≥) 150 milligram/deciliter (mg/dL) and less than 500 mg/dL, as well as low density lipoprotein cholesterol (LDL-C) level greater than or equal to (≥) 70 mg/dL * For Part C, participants should be first-generation Japanese origin. * Have a body mass index (BMI) of 18.5 to 40.0 kilograms per square meter (kg/m²) * Male participants must agree to adhere to contraception restrictions and female participants must not be able to get pregnant
Exclusion criteria
* Have taken any prescription medications that are for lowering serum TGs within the past 2 months (use of statins is allowed if the dose has been stable for 8 weeks) * Have Type 1 diabetes * Are currently participating in or completed a clinical trial within the last 30 days * Are heavy alcohol drinkers or heavy cigarette smokers * Have donated blood of more than 500 millilitres (mL) in the last 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | Baseline up to Week 53 | A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PD: Change From Baseline in Fasting Triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C) | Predose through Week 53 | PD: Change From Baseline in Fasting TG and LDL-C |
| Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3561774 | Predose through Day 8 | PK: AUC\[0-tlast\] of LY3561774 |
| PK: Maximum Observed Drug Concentration (Cmax) of LY3561774 | Predose through Day 8 | PK: Cmax of LY3561774 |
| PK: Time of Maximum Observed Concentration (Tmax) of LY3561774 | Predose through Day 8 | PK: Tmax of LY3561774 |
Countries
United States
Outcome results
None listed