Clinical trial NCT04644809: A Study of LY3561774 in Participants With Dyslipidemia
Official title: A Single-Ascending and Repeat-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3561774
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemias
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2020-11-25
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
timeFrame: Baseline up to Week 53
Secondary outcomes:
measure: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to the Last Measurable Concentration (AUC[0-tlast]) of LY3561774
timeFrame: Predose through Day 8
measure: PK: Maximum Observed Drug Concentration (Cmax) of LY3561774
timeFrame: Predose through Day 8
measure: PK: Time of Maximum Observed Concentration (Tmax) of LY3561774
timeFrame: Predose through Day 8
measure: PD: Change From Baseline in Fasting Triglyceride (TG) and low-density lipoprotein cholesterol (LDL-C)
timeFrame: Predose through Week 53
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Altasciences Clinical Los Angeles, Inc
state: California
city: Long Beach
country: United States
facility: Collaborative Neuroscience Research, LLC
state: California
city: South Miami
country: United States
facility: Qps-Mra, Llc
state: Florida
city: Marlton
country: United States
facility: Hassman Research Institute
state: New Jersey
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research, LLC
state: Tennessee
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: