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LY3050258

Phase 1

Undisclosed | Small molecule | Other |Eli Lilly and Company|Trials Updated: Aug 27, 2018

LY3050258 development status

Highest phase Phase 1
Registered trials 2 across 1 sponsor since Aug 2013

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials2
Total Enrollment101

FDA Designations

No designations recorded

LY3050258 clinical trials

LY3050258 · 2 trials · 2 indications

Phase 1 2
NCT02121834A Study of LY3050258 in Healthy ParticipantsHealthy Volunteers
COMPLETED63 Analytics
NCT01929707A Study of LY3050258 in Healthy ParticipantsHealthy Participants
COMPLETED38 Analytics
PHASE1COMPLETED
A Study of LY3050258 in Healthy Participants
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
A Study of LY3050258 in Healthy Participants
Healthy ParticipantsUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Baseline to Study Completion (Up to 14 Weeks)

Clinically significant events were defined as serious and other nonserious adverse events (AE) related to study drug. A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Secondary Endpoints

Pharmacokinetics (PK): Area Under the Concentration Curve During One Dosing Interval at Steady State (AUC τ,ss) of Multiple Doses of LY3050258
Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Multiple Doses of LY3050258
Baseline through 4 weeks: Day 1 at 4,8,12, 18, and 24 hours (hrs); Day 7 at Pre-dose, 4,8,and 12 hrs; Day 14 at Pre-dose; Days 26 and 27 at Pre-dose; Day 28 at Pre-dose, 4, 8,12,18, and 24 hrs
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3050258
Period 1: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 hours (h) postdose and Day 7 postdose; Period 2: Predose, 2, 4, 6, 8, 10, 12, 18, 24, 36 and 48 h postdose and Days 7, 14, and 21 postdose.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
LY3050258EXPERIMENTALDaily dose of LY3050258 for 28 days: Cohort A 10 mg, Cohort B 30 mg, Cohort C 90 mg, Cohort D 180 mg and Cohort E 360 mg.
PlaceboPLACEBO_COMPARATORDaily dose of placebo matching LY3050258 for 28 days.

Interventions

NameTypeDescription
LY3050258DRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range30 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy males or healthy postmenopausal females, including Japanese participants * Body mass index (BMI) of 18 and 35 kilograms per square meter (kg/m\^2), inclusive Exclusion Criteria: * Abnormal siting blood pressure as determined by the investigator * Abnormality in the 1...

Countries:United States
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Frequently asked questions about LY3050258

What is LY3050258?

LY3050258 is an investigational small molecule being developed by Eli Lilly and Company. It has been studied in Phase 1 clinical trials in healthy participants. The specific disease or condition it is intended to treat has not been publicly disclosed.

Who makes LY3050258?

LY3050258 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker symbol LLY. Lilly is the sponsor of the clinical trials conducted for this compound.

What phase is LY3050258 in?

LY3050258 is in Phase 1 clinical development. Two Phase 1 trials have been completed, and no active trials are currently listed. The program remains investigational and has not been approved by the FDA.

What clinical trials is LY3050258 in?

LY3050258 has been evaluated in two completed Phase 1 trials: NCT02121834, which enrolled 63 healthy participants, and NCT01929707, which enrolled 38 healthy participants. Both were conducted in the United States and together enrolled 101 participants.

What were the designs of the LY3050258 trials?

Both Phase 1 trials of LY3050258 were randomized, double-blind, and placebo-controlled studies in healthy participants aged 30 years and older. NCT02121834 enrolled 63 participants and NCT01929707 enrolled 38, for a combined total of 101.