Status:
TERMINATED
A Study of LY2944876 in Healthy Japanese and Non-Japanese Participants
Lead Sponsor:
OPKO Health, Inc.
Conditions:
Healthy Volunteers
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
LY2944876 is an investigative drug for the treatment of Type 2 Diabetes Mellitus. Part A of the study will assess the safety and tolerability of single doses of LY2944876 in Japanese participants. Par...
Eligibility Criteria
Inclusion
- Healthy males or female participants
- Are first generation Japanese participants (Part A) or non-Japanese participants (Part B)
- Have a body mass index (BMI) of 18.5 to 30 kilogram per meter square (kg/m\^2), inclusive, for Part A and a BMI of 25 to 40 kg/m\^2, inclusive, for Part B at screening
- Have normal blood pressure and heart rate (after approximately 5 minutes supine and approximately 2 minutes standing) as determined by the investigator at screening
Exclusion
- Have known allergies to LY2944876, related compounds or any components of the formulation, or history of significant atopy
- Have an abnormality in the 12-lead electrocardiogram (ECG) at screening and/or baseline that, in the opinion of the investigator, increases the risks associated with participating in the study
- Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- Have a history of acute or chronic pancreatitis or elevation in serum lipase and/or amylase greater than 2 times the upper limit of normal (ULN) at screening and/or baseline
- Have known or ongoing psychiatric disorders considered clinically significant in the opinion of the investigator
- Have undergone any form of bariatric surgery
- Have fasting blood glucose levels greater than or equal to (≥) 7 millimoles per liter (mmol/L) \[≥126 milligrams per deciliter (mg/dL)\] at screening
- Have fasting triglycerides levels ≥300 mg/dL (3.4 mmol/L) at screening
- Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or an alanine transaminase (ALT) or aspartate aminotransferase (AST) levels greater than (\>) 2.5 times the ULN at screening and/or baseline
- Have used or intend to use medications that promote weight loss, within 3 months prior to screening, for the duration of the study
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT02188303
Start Date
July 1 2014
End Date
December 1 2014
Last Update
May 27 2021
Active Locations (1)
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1
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Leeds, West Yorkshire, United Kingdom