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A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Japanese Participants with Type 2 Diabetes Mellitus (J2A-JE-GZGB)

A Study of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus (J2A-JE-GZGB)

Wakayama Naohiko

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Complete

Nov. 12, 2021

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

-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.

-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 3x upper limit of normal (ULN).

Both

Type 2 Diabetes Mellitus

Part A
Single doses of LY3502970 administered orally.
Single doses of Placebo administered orally.
Part B
Multiple doses of LY3502970 administered orally.
Multiple doses of Placebo administered orally.

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

+81-42-625-5216

Sept. 27, 2021

No

none