A Study of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus
Study Details
Study Description
Brief Summary
The main purpose of this study is to learn about the side effects of LY3502970 when given to Japanese participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last up to 24 weeks, inclusive of screening and will include 10 visits to the study center.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: LY3502970 (Part A) Single doses of LY3502970 administered orally. |
Drug: LY3502970
Administered orally
|
| Experimental: LY3502970 (Part B) Multiple doses of LY3502970 administered orally. |
Drug: LY3502970
Administered orally
|
| Placebo Comparator: Placebo (Part A) Placebo administered orally. |
Drug: Placebo
Administered orally
|
| Placebo Comparator: Placebo (Part B) Placebo administered orally. |
Drug: Placebo
Administered orally
|
Outcome Measures
Primary Outcome Measures
- Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline through Week 15]
A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
Secondary Outcome Measures
- Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3502970 [Predose on Day 1 through up to Day 88]
PK: Cmax of LY3502970
- PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970 [Predose on Day 1 through up to Day 88]
PK: AUC of LY3502970
- Change from Baseline in Fasting Glucose [Baseline through Day 85]
Change from Baseline in Fasting Glucose
- Change from Baseline in Glycated Hemoglobin (HbA1c) [Baseline through Day 85]
Change from Baseline in HbA1c
- Change from Baseline in Body Weight [Baseline through Day 88]
Change from Baseline in Body Weight
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Males and females not of childbearing potential
-
Have type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year
-
Have glycated hemoglobin (HbA1c) value ≥ 7.0% and ≤ 10.0% for participants treated with diet and exercise or HbA1c ≥ 6.5% and ≤ 9.0% for participants who have washed out antidiabetic medications at screening
-
Have type 2 diabetes controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (OAM); either metformin, DPP-4 (dipeptidyl peptidase-4) inhibitor, or SGLT2 (sodium-glucose co-transporter-2) inhibitor within 3 months prior to screening. Participants must withdraw from their OAM treatment for at least 28 days prior to dosing.
Exclusion Criteria:
-
Have type 1 diabetes mellitus or latent autoimmune diabetes in adults.
-
Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization
-
Have had an episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
-
Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of
500 milligram per deciliter (mg/dL).
- Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 3× upper limit of normal (ULN).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Medical Corporation Heishinkai OPHAC Hospital | Osaka-shi | Osaka | Japan | 532-0003 |
| 2 | P-One Clinic | Hachioji | Tokyo | Japan | 192-0071 |
| 3 | Clinical Research Hospital Tokyo | Shinjuku-ku | Tokyo | Japan | 162-0053 |
| 4 | Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic | Toshima | Tokyo | Japan | 171-0014 |
| 5 | Yokohama Minoru Clinic | Yokohama | Japan | 232-0064 |
Sponsors and Collaborators
- Eli Lilly and Company
Investigators
- Study Director: Call 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 17610
- J2A-JE-GZGB