Basic Criteria
- Do you have three or more of the following conditions:
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- Type 2 diabetes with A1C ≤10% (cannot be T1DM)
Answers Must Be No
- Have you had a body weight change of more than 11 lbs. in the past 3 months?
- Do you have uncontrolled high blood pressure (≥160/100) or uncontrolled thyroid disease?
- Do you consume more than 10 drinks/week (female) or 15drinks/week(male)?
- If female, are you currently pregnant or using oral contraceptives and not willing to switch to non-oral contraceptives?
- Do you have a history of type-1 diabetes, uncontrolled type 2-diabetes or unstable diabetic retinopathy/maculopathy?
- Have you been on any weight loss medications in the past 3 months?
- Have you had any previous or planned weight loss or GI surgery that could interfere with body weight? The following are allowed if done more than 1 year ago:
- Liposuction, abdominoplasty, lap banding removed, intragastric ballon removed, duodenal-jejunal bypass sleeve removed.
- In the past 3 years, have you been diagnosed or treated for Hepatitis B or C?
- Do you have a history of portal hypertension or presence of decompensated liver disease (including hepatic encephalopathy, variceal bleeding, ascites, and spontaneous bacterial peritonitis).
- Do you have a history of any other liver disease such as drug or alcohol-induced, autoimmune hepatitis, cirrhosis?
- Is your obesity caused by other disorders like Cushing or Prader Willi syndrome?
- Do you have any current diagnosis or history of; HIV, pancreatitis, stage 4 or 5 CKD, personal or family history of medullary thyroid carcinoma?
- Do you have any history of or current cancer of any organ (except treated basal- or squamous-cell carcinoma) in the past 5 years?
- Do you have any history of or current cancer of the liver?
- Any familial history of thyroid cancer?
- Have you had any significant cardiovascular events and/or been hospitalized in the past 6 months for heart failure, stroke, TIA, acute coronary syndrome or peripheral vascular event?
- Do you have a history of autoimmune disease that has required treatment in the last 3 months including lupus, rheumatoid arthritis, inflammatory bowel disease? Exceptions are participants with vitiligo or asthma treatment.
- Have you had any suicidal thoughts within the past 3 months and/or attempted suicide within the past 2 years?
- Have you been hospitalized for active or unstable depression, schizophrenia, bipolar, mood or anxiety disorder within the past year?
- Have you had any major surgeries in the past 3 months?
- Do you have any history of or planned liver or any organ transplants?
- Have you participated in any clinical trials involving treatment for MASH, Type 2 diabetes or weight loss in the past 6 months?
- Have you participated in any other clinical trials with investigational drug or device in the past 2 months?
Answers Must Be Yes
- If female and not permanently sterile or post menopause, are you willing to use a highly effective, non-oral method of birth control? Acceptable contraceptives are:
- Intravaginal, injectable, implantable, IUD, IUS, transdermal, bilateral tubal occlusion, vasectomized partner, True abstinence
- If you are taking any psychiatric medications, have you been on a stable dose for at least 8 weeks?
- Are you willing to undergo a liver biopsy procedure during the trial?
- Are you willing to maintain a stable diet and exercise regimen throughout the trial?
- Are you willing to learn how to self-inject the medication as directed?
Compensation may be available for time and travel
Insurance is not required
PLEASE NOTE: Please confirm your eligibility before your appointment by calling : 210.714.0067
If you do not see an available appointment, please call: 210.714.0067 for availability
Transportation may be available. Call : 210.714.0067
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