The main purpose of this study is to assess the safety and tolerability of LY3025876 given alone (Part A) and in combination with liraglutide (Part B) in participants with type 2 diabetes mellitus (T2DM).
This study will also evaluate how much of the study drug enters the blood stream and how long it takes for the body to remove the study drug. Information about any side effects that may occur will also be collected. Participants will continue their usual diet and exercise program and may remain on their physician-prescribed dose of metformin. Each part of the study is expected to last 10 to 12 weeks on average, not including screening. Participants may only enroll in one part.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
72
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.
Chula Vista, California, United States
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.
Orange, California, United States
Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
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 on Day 1 up to Day 56 in each Part
Pharmacokinetics (PK): Area Under the Concentration Time Curve From Time 0 to 24 Hours (AUC[0-24]) of LY3025876
AUC(0-24) of individual participants was calculated by equation Area Under Concentration (AUC)=Dose/CL, where the clearance (CL) was estimated using a population PK model.
Time frame: Predose and 0.5 hour(hr), 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose
PK: Maximum Concentration (Cmax) of LY3025876
Time frame: Days 1 and 28: Predose and 0.5 hr, 1 hr, 2 hr, 3 hr, 4 hr, 6 hr, 8 hr, 10 hr, 12 hr, and 24 hr Postdose
Part A and Part B: Immunogenicity: The Number of Participants With Anti-LY3025876 Antibodies
Time frame: Predose on Day 7, 14, 28, 56, and 180
Pharmacodynamics (PD): Change From Baseline to Day 28 in Fasting Glucose
Least Squares Mean (LS) Mean change from baseline in fasting glucose was modeled using Mixed Effect Model Repeat Measurement (MMRM) analysis with fixed effects of baseline, treatment, day, treatment\*day interaction, and participant as a random effect.
Time frame: Baseline, Day 28
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Miami, Florida, United States
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.
Cincinnati, Ohio, United States