Status:
COMPLETED
A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exerci...
Eligibility Criteria
Inclusion
- Have Type 2 Diabetes
- Have HbA1c ≥7.0% (53 mmol/mol) to ≤9.5% (80 mmol/mol) despite diet and exercise treatment, as determined by the central laboratory at screening.
- Are naïve to insulin therapy except for gestational diabetes or ≤14 days use for acute treatment and have not used any oral or injectable antihyperglycemic medications during the 90 days preceding screening or between screening and randomization.
- Are of stable weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight other than the lifestyle and/or dietary measures for diabetes treatment.
- Have a body mass index (BMI) ≥23.0 kilogram/square meter (kg/m²) at screening.
Exclusion
- Have Type 1 Diabetes
- Have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization.
- Currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
- Have New York Heart Association functional classification IV congestive heart failure.
- Have acute or chronic pancreatitis
Key Trial Info
Start Date :
August 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 3 2025
Estimated Enrollment :
559 Patients enrolled
Trial Details
Trial ID
NCT05971940
Start Date
August 9 2023
End Date
April 3 2025
Last Update
April 23 2025
Active Locations (89)
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1
Syed Research Consultants Llc
Sheffield, Alabama, United States, 35660
2
Epic Medical Research - Surprise
Surprise, Arizona, United States, 85378
3
Quality of Life Medical & Research Center
Tucson, Arizona, United States, 85712
4
Neighborhood Healthcare Institute of Health
Escondido, California, United States, 92025