Status:
COMPLETED
A Study of LY3457263 Alone and in Combination With Dulaglutide (LY2189265) in Participants With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
Brief Summary
The main purpose of this study is to investigate the safety and tolerability of the study drug LY3457263 when administered alone or in combination with glucagon-like peptide 1 (GLP-1) receptor agonist...
Eligibility Criteria
Inclusion
- Participants with type 2 diabetes (T2D) at least 6 months before screening
- Participants treated for T2D with diet and exercise, with or without metformin
- Have a glycated hemoglobin A1c (HbA1c) value of ≥ 7.5% and ≤10.5%
- Have had a stable body weight for 3 months and body mass index (BMI) of 27.0 to 45.0 kilograms per meter squared (kg/m²)
- Male participants who agree to use effective methods of contraception and female participants not of childbearing potential
Exclusion
- Have a history of or current cardiovascular, respiratory, hepatic, renal, GI, endocrine (apart from T2D), hematological, or neurological disorders capable of altering the absorption, metabolism, or elimination of drugs
- Have type 1 diabetes mellitus or latent autoimmune diabetes in adults or maturity-onset diabetes of the young
- Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy
- Have known allergies to GLP-1 receptor agonists
Key Trial Info
Start Date :
June 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 22 2023
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT05377333
Start Date
June 2 2022
End Date
November 22 2023
Last Update
January 11 2024
Active Locations (5)
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1
Pinnacle Research Group, LLC
Anniston, Alabama, United States, 36207
2
CenExel ACT
Anaheim, California, United States, 92801
3
Qps-Mra, Llc
South Miami, Florida, United States, 33143
4
Atlanta Center of Medical Research
Atlanta, Georgia, United States, 30331 2012