A Study of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus
- Registration Number
- NCT05086445
- Lead Sponsor
- Eli Lilly and Company
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo (Part B) Placebo Placebo administered orally. LY3502970 (Part B) LY3502970 Multiple doses of LY3502970 administered orally. Placebo (Part A) Placebo Placebo administered orally. LY3502970 (Part A) LY3502970 Single doses of LY3502970 administered orally.
- Primary Outcome Measures
Name Time Method 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 Baseline through Week 15 A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module
- Secondary Outcome Measures
Name Time Method Change from Baseline in Glycated Hemoglobin (HbA1c) Baseline through Day 85 Change from Baseline in HbA1c
Change from Baseline in Body Weight Baseline through Day 88 Change from Baseline in Body Weight
Change from Baseline in Fasting Glucose Baseline through Day 85 Change from Baseline in Fasting Glucose
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970 Predose on Day 1 through up to Day 88 PK: AUC of LY3502970
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3502970 Predose on Day 1 through up to Day 88 PK: Cmax of LY3502970
Trial Locations
- Locations (5)
Medical Corporation Heishinkai OPHAC Hospital
🇯🇵Osaka-shi, Osaka, Japan
Clinical Research Hospital Tokyo
🇯🇵Shinjuku-ku, Tokyo, Japan
P-One Clinic
🇯🇵Hachioji, Tokyo, Japan
Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic
🇯🇵Toshima, Tokyo, Japan
Yokohama Minoru Clinic
🇯🇵Yokohama, Japan