Cholesterol Research Study for Adults With Diabetes or Metabolic Syndrome

Basic Criteria 

• MUST be at least 18 years old 

• Must either have a diagnosis of type 2 diabetes for at least 6 months, OR  

• Must have metabolic syndrome defined as having triglyceride levels ≥150 mg/dL AND at least 2 of the following: 

• • Fasting blood sugar of 100 mg/dL or higher (or A1c over 5.7%, or taking diabetes medication) 

• • HDL cholesterol less than 40 mg/dL for men or less than 50 mg/dL for women 

• • Waist circumference of 40 inches or more for men, or 35 inches or more for women (31.5 inches for Asian men, 31.5 inches for Asian women) 

• • High blood pressure (130/85 or higher, or taking blood pressure medication) 

• • Signs of kidney disease (urine albumin-creatinine ratio of 30 or higher) 

• Must be currently taking cholesterol medication (like a statin, bempedoic acid, or a PCSK9 inhibitor) as listed below: 
  • Statin examples: atorvastatin (Lipitor), Simvastatin (Zocor), Rosuvastatin (Crestor)
  • Bempdoic acid: Nexletol, Nexlizet
  • PCSK9 inhibitor: Alirocumab (praluent), evolocumab (Repatha), inclisiran (Leqvio)
• Must be on a stable dose of cholesterol medication for at least 8 weeks (or at least 4 doses if you’re on an injectable like Repatha or Praluent)  

Answers Must Be NO 

• For women: Are you currently pregnant, breastfeeding, or planning to become pregnant during the study? 
• Have you been diagnosed with homozygous familial hypercholesterolemia (an inherited condition causing extremely high cholesterol)? 
• Do you have an HbA1c ≥10.0%? 
• Do you have uncontrolled severe hypertension, defined as  ≥160/≥100 mmHg? 
• Do you have severe heart failure (New York Heart Association Class III or IV), or has your heart’s pumping function (ejection fraction) been measured at less than 30%? 
• Have you been hospitalized for heart failure in the past 5 years? 
• Do you have active liver disease, including hepatitis or cirrhosis? 
• Have you been diagnosed with cancer in the past 3 years that required surgery (other than minor skin procedures), radiation, or chemotherapy? 
• Have you had weight loss surgery (like gastric sleeve or gastric bypass) in the past 12 months, or are you planning to have weight loss surgery during the study? 
• Are you currently enrolled in, or have you recently participated (within 3 months) in a weight loss program, or are you planning to join one during the study? 
• Has your weight changed by more than 5% in the past 3 months? 
• Are you currently taking or have you taken gemfibrozil (a type of cholesterol medication) in the past 30 days? 
• Are you currently taking or have you taken ezetimibe (Zetia) in the past 14 days? 
• Have you taken any investigational medications or used investigational devices in the past 30 days? 
• Do you have a known history of alcohol or drug abuse within the past 5 years? 
• Are you allergic or have you had a bad reaction to obicetrapib, ezetimibe, or any ingredients in these medications? 
• Do you have any medical or surgical condition which would put you at increased risk from participating in the study? 

Answers Must Be YES 

• For women of childbearing potential: Are you willing to use effective birth control from now until 35 days after your last dose of study medication? 
  • implantable contraceptives, injectable contraceptives, oral contraceptives, transdermal contraceptives, IUD, and barrier methods 
  • a sterile sexual partner for at least 3 months prior 
  • sexual abstinence 
• For women of non-childbearing potential, are you either: 
  • surgically sterilized (hysterectomy, tubal ligation, bilateral salpingectomy, bilateral oophorectomy, or bilateral salpingo-oophorectomy) at a minimum of 90 days prior or 
  • postmenopausal (defined as no menses for ≥12 months without an alternative medical cause) 
• Are you willing and able to sign an informed consent form and follow all study procedures? 
• Can you commit to attending all study visits over the next 13 months? 
• Are you willing to stay on the same dose of your current cholesterol medications throughout the study period? 
• If you take diabetes medications (including GLP-1 medications like Ozempic, Mounjaro, or Wegovy): Have you been on a stable dose for at least 3 months, and are you willing to stay on the same dose during the first 12 weeks of the study?