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

NCT ID: NCT06362265

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-10

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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LY3209590

LY3209590 administered subcutaneously (SC).

Group Type EXPERIMENTAL

LY3209590

Intervention Type DRUG

Administered SC.

Interventions

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LY3209590

Administered SC.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status RECRUITING

Children's Healthcare of Atlanta - Center for Advanced Pediatrics

Atlanta, Georgia, United States

Site Status RECRUITING

Centricity Research Columbus Endocrinology

Columbus, Georgia, United States

Site Status RECRUITING

Johns Hopkins Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

Joslin Diabetes Center

Boston, Massachusetts, United States

Site Status RECRUITING

UBMD Pediatrics

Buffalo, New York, United States

Site Status NOT_YET_RECRUITING

NYU Langone

New York, New York, United States

Site Status NOT_YET_RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Site Status RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status NOT_YET_RECRUITING

Lifedoc Research - Lenox Park Drive

Memphis, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

1-317-615-4559

Physicians interested in becoming principal investigators please contact

Role: CONTACT

Facility Contacts

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Role: primary

323-361-7116

Role: primary

404-785-5437

Role: primary

706-996-2921

Role: primary

410-955-6463

Role: primary

617-732-2603

Role: primary

716-323-0160

Role: primary

212-263-9910

Role: primary

513-636-4744

Role: primary

215-590-3174

Role: primary

901-683-0024

Related Links

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Other Identifiers

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I8H-MC-BDDB

Identifier Type: OTHER

Identifier Source: secondary_id

18437

Identifier Type: -

Identifier Source: org_study_id

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