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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

LY3437943

Placebo

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Medical Corporation Heishinkai OCROM Clinic
P-one clinic
Clinical Research Hospital Tokyo
Yokohama Minoru Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3437943

Placebo

Arm Description

LY3437943 administered subcutaneously (SC)

Placebo administered SC

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943

PK: Cmax of LY3437943

PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943

PK: AUC of LY3437943

Change from Baseline in Mean Daily Plasma Glucose (PG)

Change from baseline in mean daily PG from 6-point PG profile

Change from Baseline in Glycated Hemoglobin (HbA1c)

Change from Baseline in HbA1c

Change from Baseline in Fasting Glucose

Change from Baseline in Body Weight

Full Information

NCT ID

NCT04823208

First Posted

March 29, 2021

Last Updated

August 19, 2022

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT04823208

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

May 24, 2021 (Actual)

Primary Completion Date

June 23, 2022 (Actual)

Study Completion Date

June 23, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY3437943

Arm Type

Experimental

Arm Description

LY3437943 administered subcutaneously (SC)

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC

Intervention Type

Drug

Intervention Name(s)

LY3437943

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Description

A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Time Frame

Baseline through Day 106

Secondary Outcome Measure Information:

Title

Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943

Description

PK: Cmax of LY3437943

Time Frame

Predose on Day 1 through Day 81

Title

PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943

Description

PK: AUC of LY3437943

Time Frame

Predose on Day 1 through Day 81

Title

Change from Baseline in Mean Daily Plasma Glucose (PG)

Description

Change from baseline in mean daily PG from 6-point PG profile

Time Frame

Baseline through Day 80

Title

Change from Baseline in Glycated Hemoglobin (HbA1c)

Description

Change from Baseline in HbA1c

Time Frame

Baseline through Day 78

Title

Change from Baseline in Fasting Glucose

Description

Change from Baseline in Fasting Glucose

Time Frame

Baseline through Day 78

Title

Change from Baseline in Body Weight

Description

Change from Baseline in Body Weight

Time Frame

Baseline through Day 78

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Medical Corporation Heishinkai OCROM Clinic

City

Suita-shi

State/Province

Osaka

ZIP/Postal Code

565-0853

Country

Japan

Facility Name

P-one clinic

City

Hachioji

State/Province

Tokyo

ZIP/Postal Code

192-0071

Country

Japan

Facility Name

Clinical Research Hospital Tokyo

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

162-0053

Country

Japan

Facility Name

Yokohama Minoru Clinic

City

Yokohama

ZIP/Postal Code

232-0064

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

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

Description

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

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

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