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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

LY3502970

Placebo

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Medical Corporation Heishinkai OPHAC Hospital
P-One Clinic
Clinical Research Hospital Tokyo
Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic
Yokohama Minoru Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

LY3502970 (Part A)

LY3502970 (Part B)

Placebo (Part A)

Placebo (Part B)

Arm Description

Single doses of LY3502970 administered orally.

Multiple doses of LY3502970 administered orally.

Placebo administered orally.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

PK: Cmax of LY3502970

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

PK: AUC of LY3502970

Change from Baseline in Fasting Glucose

Change from Baseline in Glycated Hemoglobin (HbA1c)

Change from Baseline in HbA1c

Change from Baseline in Body Weight

Full Information

NCT ID

NCT05086445

First Posted

October 20, 2021

Last Updated

November 25, 2022

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT05086445

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 1, 2022

Overall Recruitment Status

Completed

Study Start Date

November 12, 2021 (Actual)

Primary Completion Date

September 5, 2022 (Actual)

Study Completion Date

September 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY3502970 (Part A)

Arm Type

Experimental

Arm Description

Single doses of LY3502970 administered orally.

Arm Title

LY3502970 (Part B)

Arm Type

Experimental

Arm Description

Multiple doses of LY3502970 administered orally.

Arm Title

Placebo (Part A)

Arm Type

Placebo Comparator

Arm Description

Placebo administered orally.

Arm Title

Placebo (Part B)

Arm Type

Placebo Comparator

Arm Description

Placebo administered orally.

Intervention Type

Drug

Intervention Name(s)

LY3502970

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

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

Description

A summary of TEAEs, SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Time Frame

Baseline through Week 15

Secondary Outcome Measure Information:

Title

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

Description

PK: Cmax of LY3502970

Time Frame

Predose on Day 1 through up to Day 88

Title

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

Description

PK: AUC of LY3502970

Time Frame

Predose on Day 1 through up to Day 88

Title

Change from Baseline in Fasting Glucose

Description

Change from Baseline in Fasting Glucose

Time Frame

Baseline through Day 85

Title

Change from Baseline in Glycated Hemoglobin (HbA1c)

Description

Change from Baseline in HbA1c

Time Frame

Baseline through Day 85

Title

Change from Baseline in Body Weight

Description

Change from Baseline in Body Weight

Time Frame

Baseline through Day 88

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Medical Corporation Heishinkai OPHAC Hospital

City

Osaka-shi

State/Province

Osaka

ZIP/Postal Code

532-0003

Country

Japan

Facility Name

P-One Clinic

City

Hachioji

State/Province

Tokyo

ZIP/Postal Code

192-0071

Country

Japan

Facility Name

Clinical Research Hospital Tokyo

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

162-0053

Country

Japan

Facility Name

Medical Corporation Houeikai Sekino Clinical Pharmacology Clinic

City

Toshima

State/Province

Tokyo

ZIP/Postal Code

171-0014

Country

Japan

Facility Name

Yokohama Minoru Clinic

City

Yokohama

ZIP/Postal Code

232-0064

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://trials.lillytrialguide.com/en-US/trial/19e2wyNokvTUEXgJp8UDry

Description

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

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

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