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

Recruiting
10 - 17 years of age
Both
Phase 1

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Overview

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.

Eligibility

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 of approximately 6% or more within 3 months prior to screening.
  • 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

Study details

Type 2 Diabetes Mellitus

NCT06362265

Eli Lilly and Company

30 March 2025

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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