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Completed

NCT Number: NCT07073170

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University People's Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3549492

Drug

Administered orally

Placebo

Drug

Administered orally

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

    Time frame: 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 outcomes

  1. Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3549492

    Time frame: Predose through Week 13

  2. PK: Area Under the Concentration Versus Time Curve (AUC) of LY3549492

    Time frame: Predose through Week 13

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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