Basic Criteria:
- Be 18-80 years of age
- Qualified participants must have a BMI of between 30-42 (Click the link to calculate)
- Have a history of at least one unsuccessful dietary effort to lose body weight.
- Hypertension or hyperlipidemia, must be controlled with stable dose/therapy on study and for the 3 months prior to Day 1.
Answers Must Be No
- Is your obesity related to endocrinological disorders?
- Have any prior diagnosis of diabetes Type 1 or Type 2 or a rare form of diabetes?
- Are you currently or have you participated in an organized weight reduction program in the last 3 months?
- Do you have a history of significant major depressive disorders or other psychiatric disorders that also include suicidal behaviors? (Schizophrenia, bipolar disorder, major mood or anxieties)
- FEMALES- Are you currently pregnant or breastfeeding?
- FEMALES- Are you of childbearing potential? If so, are you using the following highly effective birth control methods:
- Intrauterine devices (IUD)
- Intrauterine hormone-releasing system (IUS)
- Bilateral tubal occlusion or ligation
- Azoospermia (zero sperm count) partner either vasectomized or is unable to produce sperm due to medical condition.
- Combined (estrogen and progestogen) hormonal contraception including oral pills, intravaginal rings, transdermal patch, and injectable forms.
Exceptions are mild depression, and mild anxiety must be stable for 3 months prior to day 1.
- Have a history of clinically significant gastric emptying abnormality? (the time it takes for food to empty stomach)
- Are you taking drugs that affect GI motility? (the normal movement of food through the digestive tract)
- Have you had surgical treatment for obesity including gastric bypass, restrictive bariatric surgery, endoscopic or device-based therapy within the year or plans to undergo surgical treatment for obesity including endoscopic or device-based therapy?
Exceptions:
Liposuction or tummy tuck >1 year prior is eligible
Endoscopic procedure or removal of device-based therapy (e.g. Lap-band, Duodenal-jejunal bypass sleeve) >1 year prior is eligible.
- Have you had a heart attack, chest pain (angina) or stroke within the last 6 months?
- Are you currently in heart Failure class five? (Symptoms of heart failure at rest. Any physical activity causes further discomfort)
- Do you have uncontrolled high blood pressure, high cholesterol, low blood pressure, arrythmias, or abnormal ECGs even with stable doses of medication?
Exceptions:
High blood pressure must be controlled with a mean seated blood pressure of 140/90 and high cholesterol with stable medication for 3 months prior to day 1.
- Do you have a history of cancer within the last 5 years?
Exceptions:
Fully excised nonmelanoma skin cancers or nonmetastatic prostate cancer must have been stable equal or greater than 6 months.
- Do you currently have an active infectious disease, or have you been hospitalized for a serious infection in the last three months?
- Do you currently abuse drugs or alcohol?
- Do you have any history of immunodeficiencies or autoimmune diseases?
- Do you have chronic liver disease stage 3 or 4, acute kidney injury, or presence of gallbladder disease?
- Do you have chronic pancreatitis or a presence of pancreatitis in the last 180 days?
- Do you currently have gastric ulcers or a recent history within the last 3 months?
- Do you have a personal or familial history of medullary thyroid carcinoma (cancer that forms inside your thyroid gland) or multiple endocrine neoplasia type 2 (causes tumors in the thyroid and parathyroid glands, adrenal glands, lips, mouth, eyes and digestive tract)?
- Do you currently use any medications, nutritional supplements or over the counter weight loss products for weight loss within the last 6 months?
- Do you have any current or history of medication that caused significant weight gain within the last 3 months?
Exceptions:
Corticosteroids must be stable for at least 3 months.
- Have you participated in any other investigation therapy or device within 90 days?
- Have you received any live vaccinations within the last 28 days or plans to receive one?
Exceptions:
Non live vaccines ex Covid vaccine
- Are you currently taking of the following:
- Immunosuppressive biologic or targeted therapy within 90 days?
- Use of anti-inflammatories medication of no more than 800 MG/day within 30 days? (ibuprofen)
- Use of Colchicine within 30 days?
- Glucose -lowering agents for conditions other than diabetes in 90 days?
- Unable or unwilling to stop anticoagulants medications during a certain part of the study?
- Are you anticipating changing (start, stop, or change in dose) to any concomitant therapies?
- Plans to start, stop or change thyroid treatment within 2 months?
- Plans to start stop or change ADHD treatment within 3 months?
Answers Must Be Yes
- Have you had a history of at least 1 unsuccessful dietary effort to lose body weight?
- Has your body weight been stable for at least 3 months?
- MALES- Are you willing to refrain from donating sperm during the study and 90 days after last dose?
- MALES- Are you willing to use condoms?
- Are you willing to comply with study requirements and restrictions?
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
Schedule Appointment