A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
- Registration Number
- NCT05971940
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 559
- 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 naïve 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.
- 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 pancreatitis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Orforglipron Dose 3 Orforglipron Participants will receive orforglipron orally. Placebo Placebo Participants will receive placebo orally. Orforglipron Dose 1 Orforglipron Participants will receive orforglipron orally. Orforglipron Dose 2 Orforglipron Participants will receive orforglipron orally.
- Primary Outcome Measures
Name Time Method Change from Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 40
- Secondary Outcome Measures
Name Time Method Percentage of Participants with an HbA1c target value of <7.0% (53 mmol/mol) Week 40 Percentage of Participants with an HbA1c target value of ≤6.5% (48 mmol/mol) Week 40 Change from Baseline in Fasting Serum Glucose Baseline, Week 40 Percentage Change from Baseline in Body Weight Baseline, Week 40 Change from Baseline in Body Weight Baseline, Week 40 Change from Baseline in Daily Average 7-point Self-Monitored Blood Glucose (SMBG) Baseline, Week 40 Change from Baseline in Systolic Blood Pressure (SBP) Baseline, Week 40 Change from Baseline in Non-HDL Cholesterol Baseline, Week 40 Percentage Change from Baseline in Triglycerides Baseline, Week 40 Percentage of Participants Who Achieved Weight Loss of ≥5% Week 40 Change from Baseline in Short Form 36 Version 2 (SF-36v2) Acute Form Domain Scores Baseline, Week 40
Trial Locations
- Locations (88)
Syed Research Consultants Llc
🇺🇸Sheffield, Alabama, United States
Epic Medical Research - Surprise
🇺🇸Surprise, Arizona, United States
Quality of Life Medical & Research Center
🇺🇸Tucson, Arizona, United States
Neighborhood Healthcare Institute of Health
🇺🇸Escondido, California, United States
Velocity Clinical Research, Huntington Park
🇺🇸Huntington Park, California, United States
Ark Clinical Research
🇺🇸Long Beach, California, United States
Velocity Clinical Research, Westlake
🇺🇸Los Angeles, California, United States
Infinity Clinical Research - Norco
🇺🇸Norco, California, United States
Norcal Endocrinology & Internal Medicine
🇺🇸San Ramon, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Scroll for more (78 remaining)Syed Research Consultants Llc🇺🇸Sheffield, Alabama, United States