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

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Lilly

Status and phase

Not yet 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)

22 participants in 1 patient group

LY3209590
Experimental group
Description:
LY3209590 administered subcutaneously (SC).
Treatment:
Drug: LY3209590

Trial contacts and locations

10

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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