Clinical trial NCT06362265: A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus
Official title: A Single Dose Study to Evaluate the Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: Insulin
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 22
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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 criteria: 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

Primary outcomes:
measure: Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590
timeFrame: Predose up to 65 days post dose
measure: PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590
timeFrame: Predose up to 65 days post dose
Secondary outcomes:
measure: Change from Baseline in Fasting Glucose
timeFrame: Baseline, 65 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Honor Health Research Institute
state: Arizona
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta - Center for Advanced Pediatrics
state: Georgia
city: Columbus
country: United States
facility: Centricity Research Columbus Endocrinology
state: Georgia
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Boston
country: United States
facility: Joslin Diabetes Center
state: Massachusetts
city: Buffalo
country: United States
facility: UBMD Pediatrics
state: New York
city: New York
country: United States
facility: NYU Langone
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Memphis
country: United States
facility: Lifedoc Research - Lenox Park Drive
state: Tennessee
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References: