A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone (J2A-MC-GZGT)

Active, not recruiting

• Conditions: Type 2 Diabetes

• Registration Number: jRCT2031230325
• Lead Sponsor: Eli Lilly Japan K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-05
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

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 naive 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 Criteria

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 hepatitis

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
-		Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Week 40 ]