Type 2 Diabetes
Conditions
Interventions
Drug: Orforglipron
Administered orally.
Other Name: LY3502970
Drug: Placebo
Administered orally.
Study Arms
Experimental: Orforglipron Dose 1
Participants will receive orforglipron orally.
Interventi
Sponsors
Masaki Takeshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Have Type 2 Diabetes (T2D) Have HbA1c>=7.0% [53 mmol/mol] to =90 days prior to screening visit 1 and have maintained the same doses through randomization: insulin glargine U-100 (100 U/mL) >=0.20 U/kg/QD (units per kilogram per day) or >=15 U/QD alone, or insulin glargine U-100 (100 U/mL)>=0.20 U/kg/QD or >=15 U/QD in combination with metformin, or SGLT-2 inhibitor. Are of stable body weight (+-5%) for at least 90 days prior to screening visit 1 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 kg/m^2 at baseline.
Exclusion criteria
Exclusion criteria: Have New York Heart Association functional classification III-IV congestive heart failure. Have had any of the following cardiovascular conditions within 60 days prior to baseline. acute myocardial infarction cerebrovascular accident (stroke), or hospitalization for congestive heart failure. Have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease Have had chronic or acute pancreatitis any time.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Orforglipron Dose 1, 2: Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 40 ] | — |
Countries
Brazil, China, Japan, Puerto Rico, Romania, United States
Contacts
Public ContactTrial Guide Call Center
Eli Lilly Japan K.K.
Outcome results
None listed