A Study of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus

JRCT ID: jRCT2031210420

Registered date:11/11/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Type 2 Diabetes Mellitus
• Date of first enrollment: 12/11/2021
• Target sample size: 65
• Study type: Interventional

Intervention(s)

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.

Outcome(s)

• Primary Outcome: 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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 70age old
• Gender: Both

Include 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.

Exclude 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 3x upper limit of normal (ULN).

Related Information

• Primary Sponsor: Wakayama Naohiko
• Secondary ID(s): NCT05086445