A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM)

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04823208
• Other study ID #: 17609
• Secondary ID: J1I-JE-GZBC
• Status: Completed
• Phase: Phase 1
• Start date: May 24, 2021
• Est. completion date: June 23, 2022

Study information

• Verified date: August 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to learn about the side effects of LY3437943 when given to Japanese participants with type 2 diabetes mellitus. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943 or placebo given just under the skin. For each participant, the study will last up to 5 months, inclusive of screening and will include 16 visits to the study center.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 23, 2022
• Est. primary completion date: June 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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 3× upper limit of normal (ULN).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• LY3437943
Administered SC
• Placebo
Administered SC

Locations

Country	Name	City	State
Japan	P-one clinic	Hachioji	Tokyo
Japan	Clinical Research Hospital Tokyo	Shinjuku-ku	Tokyo
Japan	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka
Japan	Yokohama Minoru Clinic	Yokohama

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Day 106
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943	PK: Cmax of LY3437943	Predose on Day 1 through Day 81
Secondary	PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943	PK: AUC of LY3437943	Predose on Day 1 through Day 81
Secondary	Change from Baseline in Mean Daily Plasma Glucose (PG)	Change from baseline in mean daily PG from 6-point PG profile	Baseline through Day 80
Secondary	Change from Baseline in Glycated Hemoglobin (HbA1c)	Change from Baseline in HbA1c	Baseline through Day 78
Secondary	Change from Baseline in Fasting Glucose	Change from Baseline in Fasting Glucose	Baseline through Day 78
Secondary	Change from Baseline in Body Weight	Change from Baseline in Body Weight	Baseline through Day 78

External Links

•   A Study of LY3437943 in Japanese Participants With Type 2 Diabetes Mellitus (T2DM)