A Study of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05086445
• Other study ID #: 17610
• Secondary ID: J2A-JE-GZGB
• Status: Completed
• Phase: Phase 1
• Start date: November 12, 2021
• Est. completion date: September 5, 2022

Study information

• Verified date: November 1, 2022
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main purpose of this study is to learn about the side effects of LY3502970 when given to Japanese participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. For each participant, the study will last up to 24 weeks, inclusive of screening and will include 10 visits to the study center.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: September 5, 2022
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• Males and females not of childbearing potential
• 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 screening
• Have type 2 diabetes controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (OAM); either metformin, DPP-4 (dipeptidyl peptidase-4) inhibitor, or SGLT2 (sodium-glucose co-transporter-2) inhibitor within 3 months prior to screening. Participants must withdraw from their OAM treatment for at least 28 days prior to dosing.

Exclusion Criteria:

• Have type 1 diabetes mellitus or latent autoimmune diabetes in adults.
• 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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• LY3502970
Administered orally
• Placebo
Administered orally

Locations

Country	Name	City	State
Japan	P-One Clinic	Hachioji	Tokyo
Japan	Medical Corporation Heishinkai OPHAC Hospital	Osaka-shi	Osaka
Japan	Clinical Research Hospital Tokyo	Shinjuku-ku	Tokyo
Japan	Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic	Toshima	Tokyo
Japan	Yokohama Minoru Clinic	Yokohama

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Week 15
Secondary	Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3502970	PK: Cmax of LY3502970	Predose on Day 1 through up to Day 88
Secondary	PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970	PK: AUC of LY3502970	Predose on Day 1 through up to Day 88
Secondary	Change from Baseline in Fasting Glucose	Change from Baseline in Fasting Glucose	Baseline through Day 85
Secondary	Change from Baseline in Glycated Hemoglobin (HbA1c)	Change from Baseline in HbA1c	Baseline through Day 85
Secondary	Change from Baseline in Body Weight	Change from Baseline in Body Weight	Baseline through Day 88

External Links

•   A Study of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus