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

NCT ID: NCT04823208

Last Updated: 2022-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-24
• Study Completion Date: 2022-06-23

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY3437943

LY3437943 administered subcutaneously (SC)

Group Type: EXPERIMENTAL

LY3437943

Intervention Type: DRUG

Administered SC

Placebo

Placebo administered SC

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC

Interventions

LY3437943

Administered SC

Intervention Type: DRUG

Placebo

Administered SC

Intervention Type: DRUG

Eligibility 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 3× upper limit of normal (ULN).

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, Japan

P-one clinic

Hachiōji, Tokyo, Japan

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, Japan

Yokohama Minoru Clinic

Yokohama, , Japan

Countries

Japan

Related Links

https://trials.lilly.com/en-US/trial/283676

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

Other Identifiers

J1I-JE-GZBC

Identifier Type: OTHER

Identifier Source: secondary_id

17609

Identifier Type: -

Identifier Source: org_study_id