A Study of LY3549492 in Chinese Participants With Type 2 Diabetes Mellitus
A Phase 1, Participant- and Investigator-Blind, Placebo-Controlled, Multiple-Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Oral Daily Doses of LY3549492 in Chinese Participants With Type 2 Diabetes Mellitus
2 other identifiers
interventional
36
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 type-2-diabetes
Started Jul 2025
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 10, 2025
CompletedFirst Posted
Study publicly available on registry
July 18, 2025
CompletedStudy Start
First participant enrolled
July 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 27, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 27, 2026
CompletedMarch 3, 2026
March 1, 2026
6 months
July 10, 2025
March 2, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with One or More Serious Adverse Events (SAE) Considered by the Investigator to be Related to Study Drug Administration
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.
Baseline through Week 14
Secondary Outcomes (2)
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
Study Arms (4)
LY3549492 Dose 1
EXPERIMENTALParticipants will receive LY3549492 orally
LY3549492 Dose 2
EXPERIMENTALParticipants will receive LY3549492 orally
LY3549492 Dose 3
EXPERIMENTALParticipants will receive LY3549492 orally
Placebo
PLACEBO COMPARATORParticipants will receive Placebo orally
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Peking University People's Hospital
Beijing, 100033, China
West China Hospital of Sichuan University
Chengdu, 610041, China
Peking University First Hospital
Dongcheng District, 100009, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
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
July 10, 2025
First Posted
July 18, 2025
Study Start
July 25, 2025
Primary Completion
January 27, 2026
Study Completion
January 27, 2026
Last Updated
March 3, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share