Diabetes Mellitus, Type 2
Conditions
Brief summary
The main purpose of this study is to learn more about the safety of LY3502970 and any side effects that might be associated with it. Blood tests will be done to measure how much LY3502970 is in the bloodstream, how long it takes the body to eliminate it, and how it affects blood sugar. Participation could last up to 18 weeks and may include up to 14 visits (including three overnight stays) in the study center.
Interventions
DRUGLY3502970
Administered orally.
DRUGPlacebo
Administered orally.
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Have type 2 diabetes mellitus (T2DM) for at least 6 months * Have a glycated hemoglobin (HbA1c) value at screening of greater than or equal to (≥)7.0 percent (%) and less than or equal to (≤)10.5% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening * Have a body weight of ≥45 kilograms (kg) and have a body mass index of 18.5 to 45 kilograms per square meter (kg/m²), inclusive * Have had a stable body weight for the 3 months prior to screening (less than \[\<\]5% body weight change) * Males and females (not considered woman of childbearing potential)
Exclusion criteria
* Have type 1 diabetes mellitus, latent autoimmune diabetes in adults or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening * Have had any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure * Show evidence of hepatitis B, and/or positive hepatitis B surface antigen * Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies * Any glucose-lowering medications other than metformin within 3 months prior to screening
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug | Baseline through Follow-up (up to Day 105) | An SAE is defined as any untoward medical occurrence that, at any dose: Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect and other situations based on medical judgement. A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 | Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24, 48, 96 Hours Postdose | Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970 |
| PK: Area Under the Concentration Versus Time Curve From Time 0 to 24 Hours [AUC(0-24)] of LY3502970 | Day 84: Predose 0.5, 1, 2, 4, 6, 8,12, 24 Hours Postdose | PK: area under the concentration versus time curve from time 0 to 24 hours \[AUC(0-24)\] of LY3502970 |
| Pharmacodynamics (PD): Change From Baseline to Week 12 in Fasting Plasma Glucose (FPG) | Baseline, Week 12 | Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG). |
| PD: Change From Baseline to Week 12 in Fasting Insulin | Baseline, Week 12 | PD: Change From Baseline to Week 12 in Fasting Insulin. |
Countries
Germany, United States
Contacts
STUDY_DIRECTORCall 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)
Eli Lilly and Company
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 55.3 years STANDARD_DEVIATION 8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 30 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 58 Participants |
| Region of Enrollment Germany | 7 Participants |
| Region of Enrollment United States | 40 Participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 14 | 0 / 9 | 0 / 10 | 0 / 9 | 0 / 9 |
| other Total, other adverse events | 7 / 17 | 10 / 14 | 8 / 9 | 9 / 10 | 8 / 9 | 9 / 9 |
| serious Total, serious adverse events | 1 / 17 | 0 / 14 | 0 / 9 | 0 / 10 | 0 / 9 | 0 / 9 |
Outcome results
None listed