Status:
COMPLETED
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
Lead Sponsor:
Eli Lilly and Company
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication. This study includes 3 ...
Eligibility Criteria
Inclusion
- Have Type 2 Diabetes (T2D)
- Have HbA1c ≥7.0% (≥53 mmol/mol) to ≤10.5% (≤91 mmol/mol) as determined by the central laboratory at screening.
- 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 BMI ≥23.0 kilogram/square meter (kg/m²) at screening.
Exclusion
- Have Type 1 Diabetes (T1D).
- Have a history of severe hypoglycemia or hypoglycemia unawareness within the last 6 months prior to screening, or between screening and randomization.
- Have New York Heart Association functional classification IV congestive heart failure.
- Have had any of the following cardiovascular (CV) conditions within 60 days prior to screening, or between screening and randomization.
- acute myocardial infarction
- cerebrovascular accident (stroke), or
- hospitalization for congestive heart failure
- Have acute or chronic hepatitis and pancreatitis
Key Trial Info
Start Date :
September 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 5 2025
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT06010004
Start Date
September 28 2023
End Date
June 5 2025
Last Update
July 14 2025
Active Locations (40)
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1
Nakayama Clinic
Nagoya, Aichi-ken, Japan, 456-0058
2
Shinkashiwa Clinic
Kashiwa, Chiba, Japan, 277-0084
3
Kashiwa City Hospital
Kashiwa, Chiba, Japan, 277-0825
4
Tokuyama Clinic
Mihama-ku,Chiba City, Chiba, Japan, 261-0004