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A Randomized, Investigator- and Participant-blinded, Multiple-ascending Dose, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3549492 in Japanese Participants with Type 2 Diabetes Mellitus and Healthy Japanese Participants (J3H-JE-GZNG )

A Study of LY3549492 in Japanese Participants with Type 2 Diabetes Mellitus (T2D) and Healthy Japanese Participants
(J3H-JE-GZNG )

Wakayama Naohiko

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

LTG_CallCenter@lists.lilly.com

Trial Guide Call Center

Eli Lilly Japan K.K.

5-1-28, Isogamidori, Chuo-ku, Kobe, Hyogo

+81-120-023-812

LTG_CallCenter@lists.lilly.com

Recruiting

May. 09, 2025

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

basic science

Part A:
- Participants with T2DM for at least 6 months
- With an HbA1c value:
* equal to or greater than 7.0% and equal to or less than 10.0% at screening for participants treated with diet and exercise alone, OR
* equal to or greater than 6.5% and equal to or less than 9.0% for participants prior to washout of antidiabetic medications
- Have had a stable weight for the 3 months prior to screening. Stable weight is defined as less than 5% body weight change
Part B:
- Have safety laboratory test results within normal reference range for the population or investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Laboratory tests may be repeated if there is a documented technical error, or once at the discretion of the investigator for any out-of-range results

- Have a known clinically significant gastric emptying abnormality
- Have a 12-lead electrocardiogram (ECG) abnormality
- Have an abnormal blood pressure or pulse rate
- Have a significant history within the past 6 months or current evidence of comorbidities capable of altering the absorption, metabolism, or elimination of drug. Or constituting a risk when taking the study drug
- Have a history of chronic medical conditions involving the heart, liver, or kidneys

Both

Healthy
Type 2 Diabetes Mellitus (T2D)

DRUG: LY3549492
Administered orally
DRUG: Placebo
Administered orally

(Study Arms)
Experimental: LY3549492 Part A
LY3549492 administered orally
Interventions:
Drug: LY3549492
Experimental: LY3549492 Part B
LY3549492 administered orally
Interventions:
Drug: LY3549492
Placebo Comparator: Placebo Part A
Placebo administered orally
Interventions:
Drug: Placebo
Placebo Comparator: Placebo Part B
Placebo administered orally
Interventions:
Drug: Placebo

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 [ Time Frame: Day 1 Through Day 127
A summary of TEAEs and SAEs regardless of causality, will be reported in the Reported Adverse Events module

+81-92-283-7701

Feb. 27, 2025

No

none