Purpose of this Study
People in this study will take part for about one year. At the beginning, they will be placed into one of three groups by chance, like flipping a coin. One group will take two study medicines together. Another group will take one study medicine by itself. The third group will take a placebo, which looks like medicine but has no active drug. For the first twelve weeks, neither the participants nor the study team will know which pills are taken. During this time, people will take pills once a day, come to study visits, and have blood tests and health checks. After the first twelve weeks, everyone will take the two study medicines together for nine more months, with regular clinic visits and tests to check cholesterol levels and safety.
Who Can Participate?
Eligibility
Adults who are 18 years old or older may be able to join this study if they have type 2 diabetes, metabolic syndrome, or both. They must have high levels of bad cholesterol, called LDL cholesterol, shown by a blood test. They should already be taking cholesterol lowering medicine or be unable to take it because of side effects. People cannot join if they have serious health problems, such as very high blood pressure that is not controlled, severe heart failure, or active liver disease.
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
This study is being done to see how well new study medicines can lower bad cholesterol, also called LDL cholesterol, in people who have type 2 diabetes, metabolic syndrome, or both. These people already take cholesterol medicines, but their cholesterol is still too high. The study also checks if the medicines are safe when taken for a long time. The goal is to find better ways to lower cholesterol and help reduce the chance of future heart problems.
Locations
Duke University Hospital
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
A Placebo-Controlled, Double-Blind, Randomized, Phase 3 Study to Evaluate the Effect of Obicetrapib 10 mg and Ezetimibe 10 mg Fixed-Dose Combination or Obicetrapib 10 mg Daily on Top of Guideline-Recommended Lipid-Lowering Therapy in Participants With Type 2 Diabetes and/or Metabolic Syndrome (RUBENS trial)
Principal Investigator
Nishant
Shah
Protocol Number
PRO00119511
NCT ID
NCT07219602
Phase
III
Enrollment Status
Pending Open to Enrollment