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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: LY3502970

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Phase 1

Contacts and Locations

Study Locations

• Japan
  • Yokohama, Japan, 232-0064
    • Yokohama Minoru Clinic
  • Osaka
    • Osaka-shi, Osaka, Japan, 532-0003
      • Medical Corporation Heishinkai OPHAC Hospital
  • Tokyo
    • Hachioji, Tokyo, Japan, 192-0071
      • P-One Clinic
    • Shinjuku-ku, Tokyo, Japan, 162-0053
      • Clinical Research Hospital Tokyo
    • Toshima, Tokyo, Japan, 171-0014
      • Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo (Part A); Placebo administered orally.	Drug: Placebo; Administered orally
EXPERIMENTAL: LY3502970 (Part A); Single doses of LY3502970 administered orally.	Drug: LY3502970; Administered orally
EXPERIMENTAL: LY3502970 (Part B); Multiple doses of LY3502970 administered orally.	Drug: LY3502970; Administered orally
PLACEBO_COMPARATOR: Placebo (Part B); Placebo administered orally.	Drug: Placebo; Administered orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3502970	PK: Cmax of LY3502970	Predose on Day 1 through up to Day 88
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970	PK: AUC of LY3502970	Predose on Day 1 through up to Day 88
Change from Baseline in Fasting Glucose	Change from Baseline in Fasting Glucose	Baseline through Day 85
Change from Baseline in Glycated Hemoglobin (HbA1c)	Change from Baseline in HbA1c	Baseline through Day 85
Change from Baseline in Body Weight	Change from Baseline in Body Weight	Baseline through Day 88

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 12, 2021
• Primary Completion (ACTUAL): September 5, 2022
• Study Completion (ACTUAL): September 5, 2022

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (ACTUAL): October 21, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 17610; J2A-JE-GZGB (OTHER: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No