A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes (J2A-JE-GZPE)
- Conditions
- Type 2 Diabetes
- Registration Number
- jRCT2031230337
- Lead Sponsor
- Eli Lilly Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 399
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- parallel assignment
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method