臨床研究等提出・公開システム

Date of registration	May. 25, 2021
Last modified on	Feb. 01, 2023
Trial ID	jRCT2051210029

Scientific Title	A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943 in Japanese Participants with Type 2 Diabetes Mellitus (J1I-JE-GZBC)
Public Title	A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM) (J1I-JE-GZBC)

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

Recruitment status	Complete

Anticipated date of first enrollment		May. 24, 2021
Actual date of first enrollment		June. 25, 2021
Target sample size		66
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	double blind
	control	placebo control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	-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 lead-in and screening -Have a body mass index (BMI) within the range 23 to 35 kilograms per square meter (kg/m2), inclusive, and a body weight of at least 54 kilograms (Kg). -Males and females not of childbearing potential
	Exclusion Criteria	-Have type 1 diabetes mellitus (T1DM) -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).
	Age Minimum	20age old over
	Age Maximum	70age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Type 2 Diabetes Mellitus
Intervention(s)		LY3437943 administered subcutaneously (SC) Placebo administered SC
Primary Outcome(s)		Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Primary Sponsor	Eli Lilly Japan K.K.

Name of Certified Review Board	Medical Corporation Heishinkai OPHAC Hospital IRB
Address	4-1-29, Miyahara, Yodogawa-ku, Osaka-shi, Osaka
Telephone	+81-6-6395-9000
E-Mail	kiyoshi.yabunaka@heishinkai.com
Approval Status	Approval
Date of approval	May. 06, 2021

Plan to share IPD	No

Secondary ID(s)	NCT04823208
Issuing Authority	ClinicalTrial.gov

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Feb. 01, 2023	(this page)	Changes
2	Dec. 26, 2021	Detail	Changes
1	May. 25, 2021	Detail

List of change history