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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04823208
• Collaborator: (none)
• Enrollment: 64
• Locations: 4
• Arms: 2
• Actual Duration (Months): 13
• Patients Per Site: 16
• Patients Per Site Per Month: 1.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: LY3437943; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 64 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: May 24, 2021
• Actual Primary Completion Date: Jun 23, 2022
• Actual Study Completion Date: Jun 23, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3437943 LY3437943 administered subcutaneously (SC)	Drug: LY3437943; Administered SC
Placebo Comparator: Placebo Placebo administered SC	Drug: Placebo; Administered SC

Outcome Measures

Primary Outcome Measures

1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline through Day 106]

   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

1. Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3437943 [Predose on Day 1 through Day 81]

   PK: Cmax of LY3437943

2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3437943 [Predose on Day 1 through Day 81]

   PK: AUC of LY3437943

3. Change from Baseline in Mean Daily Plasma Glucose (PG) [Baseline through Day 80]

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

4. Change from Baseline in Glycated Hemoglobin (HbA1c) [Baseline through Day 78]

   Change from Baseline in HbA1c

5. Change from Baseline in Fasting Glucose [Baseline through Day 78]

   Change from Baseline in Fasting Glucose

6. Change from Baseline in Body Weight [Baseline through Day 78]

   Change from Baseline in Body Weight

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Corporation Heishinkai OCROM Clinic	Suita-shi	Osaka	Japan	565-0853
2	P-one clinic	Hachioji	Tokyo	Japan	192-0071
3	Clinical Research Hospital Tokyo	Shinjuku-ku	Tokyo	Japan	162-0053
4	Yokohama Minoru Clinic	Yokohama		Japan	232-0064

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: 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), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT04823208
• Other Study ID Numbers: 17609; J1I-JE-GZBC
• First Posted: Mar 30, 2021
• Last Update Posted: Aug 22, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Aug 22, 2022