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

NCT05086445 | Completed Phase 1

• 2 other identifiers: 17610J2A-JE-GZGB
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 5

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Pharmacokinetics (PK): Maximum Concentration (Cmax) of LY3502970

  Predose on Day 1 through up to Day 88

• PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970

  Predose on Day 1 through up to Day 88

• Change from Baseline in Fasting Glucose

  Baseline through Day 85

• Change from Baseline in Glycated Hemoglobin (HbA1c)

  Baseline through Day 85

• Change from Baseline in Body Weight

  Baseline through Day 88

Study Arms (4)

LY3502970 (Part A)

EXPERIMENTAL

Single doses of LY3502970 administered orally.

Drug: LY3502970

LY3502970 (Part B)

EXPERIMENTAL

Multiple doses of LY3502970 administered orally.

Drug: LY3502970

Placebo (Part A)

PLACEBO COMPARATOR

Placebo administered orally.

Drug: Placebo

Placebo (Part B)

PLACEBO COMPARATOR

Placebo administered orally.

Drug: Placebo

Interventions

LY3502970 DRUG

Administered orally

LY3502970 (Part A); LY3502970 (Part B)

Placebo DRUG

Administered orally

Placebo (Part A); Placebo (Part B)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (5)

Medical Corporation Heishinkai OPHAC Hospital

Osaka, Osaka, 532-0003, Japan

Location

P-One Clinic

Hachiōji, Tokyo, 192-0071, Japan

Location

Clinical Research Hospital Tokyo

Shinjuku-ku, Tokyo, 162-0053, Japan

Location

Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic

Toshima City, Tokyo, 171-0014, Japan

Location

Yokohama Minoru Clinic

Yokohama, 232-0064, Japan

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

orforglipron

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: October 20, 2021
• First Posted: October 21, 2021
• Study Start: November 12, 2021
• Primary Completion: September 5, 2022
• Study Completion: September 5, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11-01

Data Sharing

• IPD Sharing: Will not share

Locations

JP (5)