TRIUMPH-3 Study

STUDY BASICS

Do you have a cardiovascular disease with Type 2 Diabetes? Are you 18 years old or older? You may be able to participate in a research study to see the safety of study drug LY3437943.

STUDY PURPOSE

This study is being done to see how safe an investigational drug (LY3437943) is and how well it will work to help people with obesity and cardiovascular disease. "Investigational" means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the U.S. Food and Drug Administration (FDA). However, the FDA is allowing the use of this study drug for research. 

COULD THIS STUDY BE RIGHT FOR YOU?

Eligible participants:

• Are at least 18 years old 
• Have a body mass index (BMI) greater than or equal to 35 kg 
• Have a cardiovascular disease with Type 2 Diabetes
• Have a history of at least 1 self-reported unsuccessful dietary effort to lose body weight 

WHAT PARTICIPANTS CAN EXPECT

If you are eligible, your once-weekly injections of LY3437943 (9 mg or 12 mg) or placebo will be determined by chance. The study drug is given as an injection under your skin that is called a subcutaneous (SC) injection. 

The study starts with a 5-week screening period. As you start the study treatment phase, there will be a 16-week ramp-up period where the amount of study drug is increased slowly to help your body get used to the study treatment. When you are at a steady dose of either 9 mg or 12 mg  LY3437943 or placebo, the study treatment continues for another approximately 88 weeks, for a total study treatment period of approximately 104 weeks. 

After you stop study treatment, you will have a follow-up visit 4 weeks after receiving the last dose of study treatment. You will be asked to provide self-reported data via a tablet device or a smart phone device (questionnaires, scales, or diaries that are completed at home). You will be trained by study staff on using the devices.