GLP-1 Self-Scheduler

Basic Criteria 

• Ages 18-79 

• Currently taking semaglutide (Wegovy) injections (1.7 mg or 2.4 mg weekly) for weight loss and have been on a stable dose for at least 3 months. 

• Has responded to treatment and had approximately >8% weight loss while on semaglutide (Wegovy) treatment 

Answers Must Be NO 

• If female, are you pregnant, breastfeeding, or planning to become pregnant during the study? 

•  Are you taking Tirzepatide, Zepbound, Mounjaro, Ozempic, or any compounded versions of GLP-1 medications (from a compounding pharmacy rather than brand-name Wegovy)? 

• Have you had moderate to severe nausea and vomiting in the past 3 months (requiring medical intervention or hospitalization) 

• Have you lost or gained more than 3% of your body weight in the past 4 weeks? (will need to calculate weight gain/loss) 

• Is your blood pressure reading > 160/100 mmHg? 

• Have you ever been diagnosed with diabetes? (Exception: Gestational diabetes is okay if HbA1c is now below 6.5%) 

• Are you currently taking metformin for any reason? 

• Have you had or do you plan to have any weight loss surgery (such as gastric bypass, lap band, or gastric sleeve)? (Liposuction or tummy tuck more than 1 year ago is okay) 

•  Have you had or do you plan to have any endoscopic procedures or devices for weight loss in the past 6 months or future (such as gastric balloon, endoscopic sleeve, mucosal ablation or similar procedures)? 

• Do you have obesity caused by a hormone disorder (such as Cushing’s syndrome, Prader-Willi syndrome, or melanocortin 4 receptor deficiency)? 

• Have you used any weight loss medications in the past 6 months, such as 

• • Saxenda (liraglutide 3.0 mg), Xenical or Alli (orlistat), Meridia (sibutramine) 

• • Adipex or Lomaira (phentermine), Belviq (lorcaserin),  

• • Qsymia (phentermine/topiramate), Contrave (naltrexone/bupropion) 

• • Or any other prescription or over-the-counter weight loss products? 

• Are you taking daily stimulant medications for ADHD such as Adderall, Ritalin, or Vyvanse? (Strattera is allowed) 

• Do you have a history of long QT syndrome, or has anyone in your immediate family (parents, siblings, or children) had long QT syndrome or died suddenly before age 40? 

• Have you had unexplained fainting spells in the past year? 

• Do you have heart failure that causes shortness of breath with minimal activity or at rest (New York Heart Association Class III or IV)? 

• In the past year, have you had any of the following: 

• • Heart attack, Mini-stroke (TIA), Stroke (CVA) 

• • Procedures to restore blood flow to your legs due to blocked arteries 

• • Other major heart-related events? 

• Do you have frequent irregular heartbeats or heart rhythm problems (such as atrial fibrillation or POTS)? (Occasional extra heartbeats are okay) 

• Do you have chronic pancreatitis, or have you had more than one episode of acute pancreatitis for unknown reasons? 

• Have you ever had gallstones or bile duct stones? (If you’ve had your gallbladder removed to treat gallstones, you may be eligible) 

• Do you have chronic malabsorption problems (trouble absorbing nutrients from food)? 

• Do you have Crohn’s disease, ulcerative colitis, or other inflammatory bowel diseases? 

• Have you ever had ileus (a blockage in your intestines)? 

• Do you or anyone in your family have medullary thyroid cancer or multiple endocrine neoplasia syndrome type 2? 

• Do you have severe kidney disease stage 4 or 5? 

• Do you have cirrhosis (scarring of the liver)? 

• Do you have any condition that affects how your body absorbs, distributes, or processes medications? 

• Have you been treated for cancer in the last 5 years? (Exceptions: Skin cancer that was removed, cervical cancer in situ, or prostate cancer in situ are okay) 

• Have you had major depression or other serious mental health conditions (such as schizophrenia, bipolar disorder, or severe anxiety) in the past 2 years? 

• Do you have any of the following active infections: 

• • HIV, Hepatitis B (current infection), COVID-19? 

• • Hepatitis C (current infection with detectable virus) 

• Are you currently taking methadone, Suboxone, or Talwin for opiate addiction recovery?(Prescribed opiates for pain management are allowed) 

• Are you currently taking lovastatin (Mevacor) or simvastatin (Zocor)?(These specific statins need to be switched; other statins are okay) 

• Are you currently taking any of these medications that could interact with the study drug:
  • P-gp sensitive substrates: Dabigatran (Pradaxa), Digoxin, Everolimus, Fexofenadine (Allegra), Sirolimus, Venetoclax
  • BCRP sensitive substrates: Ozanimod, Sulfasalazine
  • P-gp inhibitors (major ones include): 
    • Amiodarone 
    • Antibiotics: Azithromycin, clarithromycin, erythromycin 
    • Antifungals: Itraconazole, ketoconazole 
    • HIV medications: Ritonavir, lopinavir, indinavir, saquinavir 
    • Heart medications: Carvedilol, dronedarone, quinidine, ranolazine, verapamil 
    • Cancer drugs: Lapatinib, osimertinib
    • COVID medications: Nirmatrelvir
  •  Strong or moderate CYP3A4 inhibitors (major ones include): 
    • Antifungals: Ketoconazole, itraconazole, posaconazole, voriconazole
    • Antibiotics: Clarithromycin, telithromycin, erythromycin 
    • HIV medications: Ritonavir, indinavir, nelfinavir, cobicistat 
    • Other: Grapefruit juice, diltiazem, verapamil, fluconazole
  •  Strong CYP3A4 inducers: Carbamazepine, Phenytoin, Rifampin, St. John’s wort, Enzalutamide 

• Are you currently in another clinical trial, or have you been in one within the past 60 days? 

• If you’ve been in a previous study, did it involve GLP-1 medications or related drugs within the past 6 months? 

• Do you have any significant ongoing medical conditions or were you hospitalized or had major surgery in the past 3 months? 

Answers Must be YES 

• Are you tolerating your semaglutide (Wegovy) treatment well? (Meaning that you have not had severe reactions, have not had to titrate down for tolerability, etc.) 
• If female of childbearing potential and sexually active, are you willing to use two form’s of birth control during the study?
• For men: Would you be willing to use birth control if you have a partner who could become pregnant, from now until 90 days after the last study dose?
• Are you willing and able to sign consent, and comply with all study requirements?
• Do you agree to not donate egg or sperm throughout the study and until 30 days after last study dose?