Nonalcoholic Fatty Liver Disease (NAFLD) Self Scheduler

You may be eligible to participate in a clinical research study evaluating an investigational medication for adults with MASH — a condition involving fat buildup and inflammation in the liver — who do not have advanced liver scarring (cirrhosis).

Qualified Participants Must:

• Male or female, age 18 to 75
• BMI of 25 or higher
• Weight has been stable over the last 3 months, and not currently on a structured weight-loss program (i.e., weight watchers)
• Diagnosed w/ type 2 diabetes, or have at least 2 of the following:
  • High triglycerides
  • Low HDL cholesterol
  • High blood pressure
  • Prediabetes

Answers Must be NO

1. Are you currently taking, or started in the last 3–6 months, any of the following:
   • Insulin
   • Resmetirom or saroglitazar
   • Semaglutide above 1 mg/week (injectable) or 14 mg/day (oral)
   • Tirzepatide above 5 mg
   • High-dose vitamin E (if taking less than 800 IU’s AND on a stable dose for 3+ months, then okay)
   • Weight-loss medications such as orlistat, phentermine, topiramate, or bupropion/naltrexone (unless stable for another medical reason for 3+ months)
   • Long-term steroids, methotrexate, amiodarone, valproate, or tamoxifen
2. Are you currently pregnant, breastfeeding, or planning to become pregnant during the study?
3. Have you had weight-loss (bariatric) surgery within the past 2 years, or one planned during the study?
4. Do you consume heavy alcohol (roughly more than 21 drinks/week for men or 14/week for women) or have you used any recreational drugs in the past year
5. Do you have uncontrolled digestive issues such as severe acid reflux, gastroparesis, chronic diarrhea, or constipation?
6. Have you been told by a doctor that you have cirrhosis (advanced liver scarring), or complications like fluid buildup in the belly, bleeding from swollen veins in the esophagus, or confusion caused by liver disease?
7. Have you been diagnosed with a liver disease other than fatty liver disease/MASH (for example, a genetic liver condition)?
8. Do you have active hepatitis B or hepatitis C?
9. Do you have HIV that is not well controlled (not on stable treatment for at least 6 months)?
10. Have you been diagnosed with type 1 diabetes, or a rarer form of diabetes such as MODY or LADA (not type 2 diabetes)?
11. Have you been diagnosed with cancer within the past 5 years (other than a treated skin cancer, or a treated mild cervical condition)?
12. Do you have a Personal or family history of medullary thyroid carcinoma (a type of thyroid cancer) or Multiple Endocrine Neoplasia type 2 (MEN2)?
13. Have you had unstable chest pain, heart attack, stroke, or mini-stroke (TIA) within the past 6 months?
14. Have you undergone any heart procedures (stent or bypass surgery) within the past 6 months, or have one planned during the study?
15. Do you have Moderate-to-severe heart failure?
16. Do you have a history of pancreatitis?
17. Do you have uncontrolled blood pressure?
18. Do you have a bleeding disorder such as hemophilia or a clotting factor deficiency?
19. Have you had treatment within the past 3 months for retinopathy?
20. Do you have obesity caused by a genetic condition or a hormone disorder (such as Cushing’s syndrome or untreated low thyroid)?
21. Do you have any severe allergic or anaphylactic reaction to GLP-1 medications (such as semaglutide, liraglutide, dulaglutide) or glucagon-based medications?
22. Are you currently enrolled in another research study, or received an investigational drug within the last 3 months?
23. Have you had signs of an active infection (such as a viral or bacterial illness, or a stomach/intestinal bug) within the past 2–4 weeks?

Answers Must be YES

1. If female and able to become pregnant:
   • Must be willing to use a highly effective form of birth control throughout the study, including oral contraceptives, contraceptive patches, implants, injections, or vaginal rings
   • Intrauterine devices [IUD], from 1 month prior to study drug administration, throughout the study, and for at least 1 month after study completion
2. Female subjects of non-childbearing potential are eligible if they are surgically sterile (bilateral oophorectomy, hysterectomy, or tubal ligation at least 3 months prior to screening), or post-menopausal (defined as > 12 consecutive months without menses).
3. If male with a partner who could become pregnant: willing to use protection and not donate sperm during the study and for 1 month after study is completed.