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Completed

NCT Number: NCT04823208

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Medical Corporation Heishinkai OCROM Clinic, Suita-shi, Osaka, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

LY3437943

Drug

Administered SC

Placebo

Drug

Administered SC

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

    Time frame: 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 outcomes

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

    Time frame: Predose on Day 1 through Day 81

    PK: Cmax of LY3437943

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

    Time frame: Predose on Day 1 through Day 81

    PK: AUC of LY3437943

  3. Change from Baseline in Mean Daily Plasma Glucose (PG)

    Time frame: Baseline through Day 80

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

  4. Change from Baseline in Glycated Hemoglobin (HbA1c)

    Time frame: Baseline through Day 78

    Change from Baseline in HbA1c

  5. Change from Baseline in Fasting Glucose

    Time frame: Baseline through Day 78

    Change from Baseline in Fasting Glucose

  6. Change from Baseline in Body Weight

    Time frame: Baseline through Day 78

    Change from Baseline in Body Weight

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 30, 2021
Registry last updated
Aug 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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