SanRo Clinical Research Group | Bryant, AR
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About
The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.
Enrollment
Sex
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Inclusion criteria
Have Type 2 Diabetes (T2D)
Have HbA1c ≥7.0% [53 mmol/mol] to ≤10.5% [91 mmol/mol]
Have been treated with stable doses of the same formulation of the following for ≥90 days prior to screening visit 1 and have maintained the same doses through randomization:
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
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.
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.
Primary purpose
Allocation
Interventional model
Masking
520 participants in 4 patient groups, including a placebo group
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Central trial contact
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
Data sourced from clinicaltrials.gov
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