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JAPANESE
国立保健医療科学院
JRCT ID: jRCT2031210420

Registered date:11/11/2021

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

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedType 2 Diabetes Mellitus
Date of first enrollment12/11/2021
Target sample size65
Countries of recruitmentJapan
Study typeInterventional
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 OutcomeNumber 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
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum<= 70age old
GenderBoth
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

Contact

Public contact
Name Trial Guide Call Center
Address 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086
Telephone +81-120-023-812
E-mail LTG_CallCenter@lists.lilly.com
Affiliation Eli Lilly Japan K.K.
Scientific contact
Name Naohiko Wakayama
Address 5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo Hyogo Japan 651-0086
Telephone +81-120-023-812
E-mail LTG_CallCenter@lists.lilly.com
Affiliation Eli Lilly Japan K.K.