Patients will be excluded (1) if they have had a heart attack, stroke, hospitalization for congestive heart failure or unstable angina within 90 days before screening, (2) if they have been taking any weight loss drugs, including over-the-counter medications, within 90 days before screening, (3) if they have had a change in body weight greater than 11 pounds within 90 days, (4) if they have or are planning a surgical treatment for excess weight, (5) if they have Type 1 Diabetes Mellitus, (6) if they have a family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2) and (7) if they have had pancreatitis
Critical Research Limitation: Despite extensive preclinical and limited early-phase human studies, the CJC-1295 (NO DAC) + Ipamorelin blend peptide has NO completed, peer-reviewed Phase III clinical trials establishing human safety and efficacy for any medical indication
Nevertheless, ongoing research efforts should be directed toward understanding the mechanism of the unique obesity phenotype of PWS and developing pharmacological therapies
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