A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus

Lilly

Status and phase: Enrolling; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: LY3209590

Study type: Interventional

Funder types: Industry

Identifiers

NCT06362265

18437

I8H-MC-BDDB (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to evaluate how much of LY3209590 gets into the blood stream after a single dose and how long it takes the body to remove it in pediatric participants with Type 2 Diabetes Mellitus (T2DM). The study will last for approximately 100 days.

Enrollment: 22 estimated patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with Type 2 Diabetes Mellitus (T2DM) for at least 3 months
• Have Glycated hemoglobin (HbA1c) level of 6.5 percent (%) to 9.5% at screening
• Have a body mass index equal to or less than 45.0 kilograms per square meter (kg/m²)
• Participants are insulin naïve or have been without insulin treatment for at least 3 months prior to screening

Exclusion criteria

• Have had a severe hypoglycemia in the past 6 months
• Have a history of renal impairment
• Have had a blood transfusion or severe blood loss within last 90 days
• Have had a significant weight gain or loss in the last 90 days
• Have a history of an active or untreated malignancy
• Are receiving or received systemic glucocorticoid therapy
• Are currently enrolled in another clinical study trial involving medical research or have participated within the last 30 days in a clinical study involving an investigational product

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

LY3209590

Experimental group

Description:

LY3209590 administered subcutaneously (SC).

Treatment:

Drug: LY3209590