Research Center: Valley Institute of Research
Location: 1217 Grand Avenue, Fort Worth, TX 76164, United States
Lead Researcher: Dr. Alex Guevara
IRB: This study has been reviewed and approved by the Advarra – Central Institutional Review Board
About the Study
Are you struggling with type 2 diabetes and weight management? Valley Institute of Research is conducting an important study that might interest you. This study focuses on Orforglipron, a promising new oral Research medication designed to improve glycemic control and aid in weight loss.
The research drug is a small molecule GLP-1 receptor agonist taken orally, making it a convenient option. This study compares Orforglipron with insulin glargine, examining its effects on heart health, blood sugar levels, and weight. By joining, you’ll contribute to groundbreaking research that could significantly improve health outcomes for many.
Interested? Take our online questionnaire and see if you qualify.
Why Participate?
- Participants may receive a new potential treatment for type 2 diabetes at no cost. They will be randomly assigned to receive either Orforglipron or insulin glargine.
- Participants will be compensated up to $84 – $300 per visit. Compensation will only be provided to eligible participants who complete the study.
- Participants may experience improvements in their heart health, blood sugar levels, and weight.
- Participants will be contributing valuable information that may benefit those with type 2 diabetes and weight struggles in the future.
- Participants will be helping to advance medical research.
Your Rights
- If you decide to participate in the study and later feel that you no longer wish to be part of it, you can withdraw at any time.
- Any information that you provide will be kept strictly confidential, except as required by law.
- Qualified health professionals will monitor your health as it relates to the study.
Who Can Participate?
- Men and women aged 18 and above who are diagnosed with type 2 diabetes and have a higher weight (a BMI of >25 kg/m²)
- Must be taking stable doses of glucose-lowering medications for at least 3 months
- Must be of stable weight for at least 90 days before the first study visit
- Must not have a history of insulin therapy or received treatment with any glucose-lowering agent(s) in the last 90 days
- Must not have taken any weight loss drugs or alternative remedies, including herbal or nutritional supplements in the last 3 months
- Must not be currently pregnant or breastfeeding
- Must not have had any episodes of diabetic ketoacidosis, and must not have been in a hyperosmolar state, or coma in the last 6 months
- Must not have had any episodes of severe hypoglycemia or hypoglycemia unawareness in the last 6 months
- Must not be currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema
- Must not have a family (first-degree relative) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type
- Must not have had chronic or acute pancreatitis
- Must not have undergone an organ transplant or are you currently awaiting an organ transplant
- Must not be currently participating or have participated in another research study in the past 30 days where you used a study medication
- Must be able to attend 25 study visits at the research site over approximately 104 weeks
More Study Details
The study team will explain the research in its entirety but some details are:
- Participants will be asked to sign a consent form and provide their health history, including information about any over-the-counter or prescription drugs, vitamins, or herbs they are taking.
- Participants will be asked to undergo evaluations and tests to determine their eligibility for the study, which includes a four-week evaluation period and potential initial exams even if they do not join the study.
- Participants will be asked to use a tablet or smartphone device to provide self-reported data during office visits or at home, with training on device usage and instructions for automatic data transfer to a secure system.
About the Research Center
Valley Institute of Research
Valley Institute of Research is committed to the success of its 3 stakeholders: its patients, the physicians within its community, and the CROs and Pharmaceutical Sponsors overseeing the clinical trials. Valley Institute of Research’s mission is to conduct research to improve minority health and eliminate health disparities.