Study Summary: This study tests a drug combination called Contrave®/Mysimba® (naltrexone hydrochloride ER and bupropion hydrochloride ER) to see if it increases the risk of major heart-related problems, called MACE (Major Adverse Cardiovascular Events). MACE can include heart attacks or strokes. The study is set up as a randomized, double-blinded, placebo-controlled trial, which means that some participants will receive the drug while others will receive a placebo (a harmless pill). Neither the participants nor the researchers will know who gets the drug or the placebo, to ensure fairness.
Key Points:
- The study requires patients to follow a reduced-calorie diet and increase physical activity.
- Participants must be 18 or older, with certain health conditions like obesity or type 2 diabetes.
- Exclusion includes recent heart attack, uncontrolled high blood pressure, or certain medication use.
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