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Monoclonal Antibodies

LY3209590 for Type 2 Diabetes

Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 65 days
Awards & highlights

Study Summary

This trial aims to see how a drug called LY3209590 is absorbed and removed from the body in children with Type 2 Diabetes. The study will take around 100 days to complete.

Who is the study for?
This clinical trial is for children and teenagers who have Type 2 Diabetes Mellitus. Participants will be involved in the study for about 100 days to see how their bodies handle a single dose of a new diabetes medication, LY3209590.Check my eligibility
What is being tested?
The trial is testing LY3209590, which is being studied to understand how much enters the bloodstream and how quickly it's eliminated from the body after one dose in young patients with Type 2 Diabetes.See study design
What are the potential side effects?
Potential side effects are not detailed here, but may include reactions typical of diabetes medications such as low blood sugar levels, nausea, or allergic reactions. Specific side effects will depend on individual patient responses.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 65 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 65 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK: Maximum Observed Plasma Concentration (Cmax) of LY3209590
Pharmacokinetics (PK): Area Under the Plasma Concentration Versus Time Curve (AUC) of LY3209590
Secondary outcome measures
Change from Baseline in Fasting Glucose

Side effects data

From 2021 Phase 2 trial • 266 Patients • NCT04450407
4%
Headache
2%
Covid-19
2%
Hypertension
1%
Patella fracture
1%
Hypoglycaemia
1%
Intervertebral disc protrusion
1%
Acute myocardial infarction
1%
Coronary artery stenosis
1%
Nasopharyngitis
1%
Sinusitis
1%
Hepatic enzyme increased
100%
80%
60%
40%
20%
0%
Study treatment Arm
Insulin Degludec
LY3209590 Algorithm 1 (Paper)
LY3209590 Algorithm 2 (Digital)

Trial Design

1Treatment groups
Experimental Treatment
Group I: LY3209590Experimental Treatment1 Intervention
LY3209590 administered subcutaneously (SC).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LY3209590
2018
Completed Phase 2
~1290

Find a Location

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,621 Previous Clinical Trials
3,216,600 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,348 Previous Clinical Trials
415,723 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there several medical facilities in North America where this clinical trial is being conducted?

"This research endeavor is being conducted at Cincinnati Children's Hospital Medical Center in Ohio, Johns Hopkins University School of Medicine in Baltimore, Maryland, and Honor Health Research Institute in Scottsdale, Arizona alongside six additional sites."

Answered by AI

What is the level of risk associated with LY3209590 for individuals?

"Given that this is a Phase 1 trial with scarce safety and efficacy data available, LY3209590 was rated as having a safety score of 1 by our team at Power."

Answered by AI

What are the eligibility criteria for individuals interested in participating in this research project?

"To qualify for this research study, individuals must have a diagnosis of type 2 diabetes and be aged between 10 and 17 years. The trial aims to recruit a total of 22 participants."

Answered by AI

Are individuals who are older than 65 years eligible to participate in this study?

"This investigation is open to individuals aged 11 to 16 years."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus
2024. "A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06362265.
~15 spots leftby Nov 2026
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