A Study of LY3549492 in Chinese Participants With Type 2 Diabetes Mellitus

Not Applicable

Not yet recruiting

• Conditions: Type 2 Diabetes
• Interventions: Drug: LY3549492; Drug: Placebo

• Registration Number: NCT07073170
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to investigate LY3549492 in Chinese participants with type 2 diabetes. Participation in the study will last about 18 weeks.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-07-10
• Study First Submitted QC: 2025-07-10
• Study First Posted: 2025-07-18
• Status Verified: 2025-08
• Study Start: 2025-08-01
• Last Update Submitted: 2025-08-25
• Last Update Posted: 2025-08-26
• Primary Completion: 2026-06
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Are native Chinese
• Have type 2 diabetes for at least 6 months
• Have been treated with diet and exercise, with or without a stable dose of metformin for at least 3 months
• Have hemoglobin A1c (HbA1c) of at least 7% and no greater than 10%
• Have a body mass index (BMI) of at least 20 milligrams per square meter (kg/m2) and no greater than 40 kg/m2
• Have had a stable body weight for the 3 months prior to screening
• Women must not be of childbearing potential

Exclusion Criteria

• Have type 1 diabetes or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization
• Have had an episode of severe hypoglycemia within 6 months or have a history of hypoglycemia unawareness
• Have a clinically significant gastric emptying abnormality
• Have or have a history of pancreatitis
• Have signs and symptoms of liver disease, with the exception of non-alcoholic fatty liver disease
• Have a personal or family history of multiple endocrine neoplasia syndrome type 2 or medullary thyroid carcinoma
• Have an uncontrolled endocrine abnormality
• Have an abnormal blood pressure or pulse rate
• Have a 12-lead electrocardiogram (ECG) abnormality
• Have a significant history within the past 6 months or current evidence of comorbidities capable of altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study intervention, or of interfering with the interpretation of data

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LY3549492 Dose 1	LY3549492	Participants will receive LY3549492 orally
LY3549492 Dose 2	LY3549492	Participants will receive LY3549492 orally
LY3549492 Dose 3	LY3549492	Participants will receive LY3549492 orally
Placebo	Placebo	Participants will receive Placebo orally

Primary Outcome Measures

Name	Time	Method
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration	Baseline through Week 14	A summary of treatment emergent adverse events (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
Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3549492	Predose through Week 13
PK: Area Under the Concentration Versus Time Curve (AUC) of LY3549492	Predose through Week 13

Trial Locations

Locations (3)

Peking University People's Hospital; 🇨🇳 Beijing, China

West China Hospital of Sichuan University; 🇨🇳 Chengdu, China

Peking University First Hospital; 🇨🇳 Dongcheng District, China