Fatty Liver Self-Scheduler

BASIC CRITERIA 

1. Are you at least 18 years old? 

2. Have you been diagnosed with fatty liver disease? (This may have been called MASLD, MASH, NAFLD, or NASH by your doctor) 

3. Do you weigh enough that your BMI is 25 or higher? (We can calculate this together if you know your height and weight) 

4. Are you able and willing to: 

• Give yourself a once-weekly injection under your skin, OR have someone who can help you with injections? 

• Come to study visits regularly for up to 3.5 years? 

• Fast (no food or drink except water) for 8 hours before some visits? 

EXCLUSION CRITERIA 

To qualify for this study, you must answer NO to these questions: 

1. Have you ever been told by a doctor that you have cirrhosis (severe scarring of the liver)? 

2. Have you ever had a liver biopsy that showed you have cirrhosis? 

3. Have you ever had any of these serious liver complications: 

• Varices (swollen blood vessels in your esophagus or stomach) 

• Ascites (fluid buildup in your belly) 

• Hepatic encephalopathy (confusion or changes in thinking caused by liver problems) 

• Bleeding from your esophagus or stomach related to liver disease 

• Vomiting blood 

4. Have you had a liver transplant, or are you on a waiting list for one? 

5. Have you been diagnosed with liver cancer in the past 5 years? 

6. Do you have any other type of liver disease besides fatty liver disease, such as: 

• Hepatitis B that is currently active? 

• Hepatitis C that hasn’t been cured, or was cured less than 2 years ago? 

• Autoimmune liver disease? 

• Alcoholic liver disease? 

• Any inherited liver diseases (like hemochromatosis or Wilson’s disease)? 

7. Do you drink alcohol regularly? 

• For men: More than 3 drinks per day or 21 drinks per week 

• For women: More than 2 drinks per day or 14 drinks per week 

• (One drink = one beer, one glass of wine, or one shot of liquor) 

8. Have you lost more than 11 pounds in the past 3 months without trying? 

9. Have you ever had weight loss surgery, such as: 

• Gastric bypass, Gastric sleeve, Lap band or any other bariatric surgery 

10. Have you ever had a procedure where something was placed in your stomach to help with weight loss, such as: 

• Gastric balloon, Endoscopic sleeve procedure or any stomach device for weight loss 

11. Do you have plans to have weight loss surgery during the study? 

12. Are you currently taking, or have you taken in the past 6 months, any of these diabetes or weight loss medications: 

• Ozempic, Wegovy, Mounjaro, Zepbound, Trulicity, Victoza, Saxenda, Bydureon 

• Rybelsus, Symlin (pramlintide), any GLP-1 medication or any “incretin” medication 

13. Are you currently taking fast-acting insulin with meals? 

(Long-acting insulin once or twice daily is okay) 

14. If you have diabetes: Has your most recent A1c been > 10%? 

15. Have you taken any prescription weight loss medications in the past 3 months, such as: 

• Xenical or Alli (orlistat), Phentermine, Qsymia, Contrave or any other prescription diet pills 

16. Have you taken any medications specifically prescribed for your fatty liver disease in the past 6 months? 

Exception: If you have been taking vitamin E, Actos (pioglitazone), or Rezdiffra (resmetirom) for at least 6 months on the same dose, you may still qualify 

17. Have you taken steroid pills or steroid injections for more than 2 weeks in the past 3 months? 

(Inhalers, nasal sprays, eye drops, and skin creams are okay) 

18. If you have diabetes: In the past 3 months, have you had: 

• Diabetic ketoacidosis (very high blood sugar with ketones) 

• A diabetic coma 

• Severe low blood sugar where you needed someone else to help you 

• Frequent low blood sugars where you can’t tell when your sugar is low 

19. If you have diabetes: Are you currently getting treatment for diabetic eye problems, such as: 

• Eye injections, Laser treatment on your eyes, Eye surgery for diabetes complications 

20. Do you have Type 1 diabetes? 

21. In the past 3 months, have you had: 

• A heart attack, A stroke, Heart surgery (bypass surgery or stent placement) 

• Been hospitalized for heart failure 

22. Do you have severe heart failure where you have symptoms even when resting? 

23. Do you have severe kidney disease? (Your doctor may have told you that you have stage 4 or 5 kidney disease, or your kidney function is very low) 

24. Have any of your close family members (parent, brother, sister, or child) had Medullary thyroid cancer or MEN-2 syndrome? 

25. Have you ever had medullary thyroid cancer yourself? 

26. Do you have severe gastroparesis (very slow stomach emptying)? 

27. Have you ever had pancreatitis (inflamed pancreas)? 

Exception: If you had pancreatitis from gallstones AND you had your gallbladder removed, you may still qualify 

28. Do you currently have gallbladder problems with symptoms? 

29. Have you had any type of cancer in the past 5 years? 

Exceptions that are okay: Skin cancer (basal cell or squamous cell), very early cervical cancer, or very early prostate cancer 

30. In the past 2 years, have you been hospitalized or diagnosed with severe depression, Bipolar disorder, Schizophrenia or other serious mental health conditions? 

31. In  the past month, have you thought about hurting yourself or suicide or Tried to hurt yourself 

32. Do you have HIV? 

33. Have you had an organ transplant?(Cornea/eye transplant is okay) 

34. Are you currently in another research study testing an investigational drug? 

35. Are you currently pregnant, breastfeeding or planning to become pregnant during the study period (up to 3.5 years)? 

INCLUSION CRITERIA 

To qualify for this study, you must answer YES to these questions: 

1. Are you willing and able to use birth control during the study if needed? 

• If you could become pregnant: You must use effective birth control throughout the study and for 5 weeks after your last dose 

• If you could get someone pregnant: You must use condoms during the study and for 5 weeks after your last dose 

2. Are you willing to follow all study requirements, including: 

• Taking a once-weekly injection at home 

• Coming to all scheduled visits (every 4 weeks for the first 6 months, then every 12 weeks) 

• Having blood tests at regular visits 

• Having imaging tests like MRI and ultrasound 

• Possibly having additional tests if your doctor thinks they’re needed (like endoscopy to look at your esophagus and stomach, or a liver biopsy) 

• Following a healthy lifestyle program (diet and exercise guidance) 

3. Are you willing to NOT drink alcohol during the study, or keep it to: 

• For men: No more than 21 drinks per week 

• For women: No more than 14 drinks per week 

4. If you take medications for your liver, diabetes, or weight, are you willing to keep taking them as directed and tell the study doctor about any changes?