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

NCT04823208 | Completed Phase 1 FDA Drug

• 2 other identifiers: 17609J1I-JE-GZBC
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  Predose on Day 1 through Day 81

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

  Predose on Day 1 through Day 81

• Change from Baseline in Mean Daily Plasma Glucose (PG)

  Baseline through Day 80

• Change from Baseline in Glycated Hemoglobin (HbA1c)

  Baseline through Day 78

• Change from Baseline in Fasting Glucose

  Baseline through Day 78

Study Arms (2)

LY3437943

EXPERIMENTAL

LY3437943 administered subcutaneously (SC)

Drug: LY3437943

Placebo

PLACEBO COMPARATOR

Placebo administered SC

Drug: Placebo

Interventions

LY3437943 DRUG

Administered SC

LY3437943

Placebo DRUG

Administered SC

Placebo

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (4)

Medical Corporation Heishinkai OCROM Clinic

Suita-shi, Osaka, 565-0853, Japan

Location

P-one clinic

Hachiōji, Tokyo, 192-0071, Japan

Location

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, 162-0053, Japan

Location

Yokohama Minoru Clinic

Yokohama, 232-0064, Japan

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

retatrutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• 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 DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2021
• First Posted: March 30, 2021
• Study Start: May 24, 2021
• Primary Completion: June 23, 2022
• Study Completion: June 23, 2022
• Last Updated: August 22, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

JP (4)