Type 2 Diabetes MellitusPhase 1NCT06362265
A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus
A Phase 1 study testing LY3209590 in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- LY3209590
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 10 sitesUnited States
- Study dates
- 10 Oct 2024to 2 Jan 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
Atlanta, Georgia, 30329
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Joslin Diabetes Center
Boston, Massachusetts, 02215
UBMD Pediatrics
Buffalo, New York, 14203
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Centricity Research Columbus Endocrinology
Columbus, Georgia, 31904
Children's Hospital Los Angeles
Los Angeles, California, 90027
Lifedoc Research - Lenox Park Drive
Memphis, Tennessee, 38115
NYU Langone
New York, New York, 10016
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Single Dose Study to Evaluate the Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus
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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- LY3209590
- Keywords
- Insulin
- Medical subject headings
- Diabetes Mellitus, Type 2, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3209590Drug
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| LY3209590 | Experimental | LY3209590 administered subcutaneously (SC). Receives: Drug: LY3209590 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590
Measured: Predose up to 65 days post dose
PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590
Measured: Predose up to 65 days post dose
Secondary outcomes (1)
Change from Baseline in Fasting Glucose
Measured: Baseline, 65 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start10 Oct 2024
- Primary completion2 Jan 2026
- Study completion2 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06362265
- Sponsor's protocol ID
- 18437
- Other IDs
- I8H-MC-BDDB
- Status last verified
- Mar 2026
- First submitted
- 9 Apr 2024
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Study to Evaluate the Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06362265
- Acronym / sponsor ID
- 18437
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Insulin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 10 Oct 2024 (actual)
- Primary completion
- 2 Jan 2026 (actual)
- Study completion
- 2 Jan 2026 (actual)
- First posted
- 12 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LY3209590 | Experimental | Drug: LY3209590LY3209590 administered subcutaneously (SC). |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LY3209590Administered SC. | Drug | LY3209590 |
Primary outcome
Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590
Time frame: Predose up to 65 days post dose
PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590
Time frame: Predose up to 65 days post dose
1 secondary outcome
Change from Baseline in Fasting Glucose
Time frame: Baseline, 65 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LY3209590 in people with Type 2 Diabetes Mellitus, run by Eli Lilly and Company at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590 (time frame: Predose up to 65 days post dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026; AzTrials last refreshed its copy on 8 Nov 2026.