LY3202328
DrugAdministered orally
NCT Number: NCT02714569
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.
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Phase 1
Clinical Pharmacology of Miami, Inc., Miami, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Administered orally
Administered orally
Administered orally
Administered orally
Time frame: Baseline, Up to 42 Days
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.
Time frame: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose
Pharmacokinetics (PK) is the maximum plasma concentration (Cmax) of LY3202328 Part A after a single dose.
Time frame: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK is the maximum plasma concentration of LY3202328 (Cmax) at steady state in Part B.
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose
PK is the area under the serum concentration time curve from zero to Infinity (AUC[0-∞]) of LY3202328 in Part A after a single dose.
Time frame: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK is the area under the serum concentration-time curve (AUCτ) of LY3202328 at steady state during the dosing interval in Part B.
Time frame: Day 1: Predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 96 hours Postdose
PK is the time to maximum concentration (Tmax) of LY3202328 in Part A
Time frame: Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK is the Tmax of LY3202328 at steady state in Part B.
Time frame: Predose, 24, 48, 96 Hours Postdose
Pharmacodynamics (PD) is the change from Baseline in Fasting High-Density Lipoprotein Cholesterol (HDL-c) in Part A.
Time frame: Predose, Days 7, 14, 21, and 28 Postdose
PD is the change from baseline to last day of dosing in fasting HDL-c in Part B.
Time frame: Predose, 24, 48, 96 Hours Postdose
PD is the change from baseline in fasting total triglycerides in Part A.
Time frame: Predose, Days 7, 14, 21, and 28 Postdose
PD is the change from baseline to last day of dosing in fasting total triglycerides in Part B.
Time frame: Predose, 24, 28, 96 Hours Postdose
PD is the change from baseline in fasting total cholesterol in Part A.
Time frame: Predose, Days 7, 14, 21, and 28 Postdose
PD is the change from baseline to last day of dosing in fasting total cholesterol in Part B.
Time frame: Predose, 24, 48, 96 Hours Postdose
PD is the change from baseline in fasting low-density lipoprotein cholesterol (LDL-c) Part A.
Time frame: Predose, Days 7, 14, 21, and 28 Postdose
PD is the change from baseline to last day of dosing in fasting LDL-c in Part B.
Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK: Cmax of Simvastatin with/without LY3202328 (LY) Co-administration in Part B.
Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK: Area Under Concentration Curve From Zero to Time (AUC [0-t]) of Simvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration.
Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK: Cmax of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B.
Time frame: Day -7 and Day 28: Predose, 0.5, 1, 2, 4, 4.5, 5, 6, 8, 12, 24 hours Postdose
PK: AUC (0-t) of Atorvastatin with/without LY3202328 (LY) Co-administration in Part B. AUC from time 0 to time t, where t is the time of last quantifiable plasma concentration.
Eli Lilly and Company
Industry
A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Oral Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of LY3202328
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06380322
Cardiovascular Diseases, Diabetes Mellitus
Fort Carson, Colorado, United States
View Trial DetailsNCT05988866
Dyslipidemias, Hypercholesterolemia
Hamburg, Germany
View Trial DetailsNCT05075902
Cardiovascular Diseases, Chronic Disease
Uberlândia, Minas Gerais, Brazil
View Trial DetailsNCT07682285
Cancer-related Fatigue, Carcinoma
Taipei, Taiwan
View Trial Details