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

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: LY3549492

Study type: Interventional

Funder types: Industry

Identifiers

NCT07073170

J3H-GH-GZNH (Other Identifier)

27335

Details and patient eligibility

About

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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 4 patient groups, including a placebo group

LY3549492 Dose 1

Experimental group

Description:

Participants will receive LY3549492 orally

Treatment:

Drug: LY3549492

LY3549492 Dose 2

Experimental group

Description:

Participants will receive LY3549492 orally

Treatment:

Drug: LY3549492

LY3549492 Dose 3

Experimental group

Description:

Participants will receive LY3549492 orally

Treatment:

Drug: LY3549492

Placebo

Placebo Comparator group

Description:

Participants will receive Placebo orally

Treatment:

Drug: Placebo