Phase 1b/2a Study to Evaluate Safety and Efficacy of Setmelanotide in Obese Patients

Exclusion Criteria

• •Fasting blood glucose \> than 140 mg/dL.
• •TSH level outside the normal range.
• •Creatinine \> 1.5 times the upper limit of normal.
• •Liver function tests \> 2 times the upper limit of normal.
• •Active or history of any significant medical condition including renal, hepatic, pulmonary, gastrointestinal, cardiovascular, genitourinary, endocrine, immunologic, metabolic, neurologic or hematological disease.
• •Patients with a history of the following:
• •1. Uncontrolled hypertension;
• •2. Diabetes requiring medical treatment;
• •3. Major depressive disorder within the last 2 years;
• •4. Any lifetime history of a suicide attempt;
• •5. Any suicidal ideation/behavior in the last month;
• •6. Other severe psychiatric disorders (e.g. schizophrenia, bipolar disorder, severe eating disorders including bulimia).
• •A PHQ-9 score of ≥15.
• •Any suicidal ideation of type 4 or 5 on the C-SSRS.
• •Prior bariatric surgery.
• •History or close family history (parents or siblings) of melanoma.
• •Significant dermatologic findings as part of the Screening comprehensive skin evaluation performed by the dermatologist.
• •Currently treated with anorectic agents or drugs in last 2 months from screening with anorexia as a frequent side event.
• •Taking more than 2 anti-hypertensive medications.
• •Acute illness or history of illness, which in the opinion of the Investigator, could pose a threat or harm to the patient or obscure interpretation of laboratory test results or interpretation of study data.
• •History of any malignancy, past or present, including skin cancer, multiple severely dysplastic nevi, or nevoid basal cell carcinoma.
• •History of HIV infection or Hepatitis B or C.
• •History of significant drug hypersensitivity or anaphylaxis.
• •History of hypersensitivity to proteins (e.g., allergy shots).
• •Any clinically significant abnormalities on screening laboratories as determined by the Investigator.
• •Abnormal 12-lead electrocardiogram (ECG) at screening, except minor deviations deemed to be of no clinical significance by the Investigator. QTcF must be \< 450 ms.
• •Received any experimental drugs or devices or have participated in a clinical study within 30 days prior to dosing.
• •Blood donation greater than 500 mL within 60 days prior to screening or intent to donate up to 30 days after Final Study Visit.
• •Hospitalization for surgery within the 3 months prior to screening except for minor outpatient procedures, or any planned hospitalizations during the study period.
• •Poor venous access or inability to tolerate venipuncture.
• •Inability to attend all study visits or comply with protocol requirements including fasting and restrictions on concomitant medication intake.
• •Participation in weight loss programs during the study period, including nutritional supplements/ replacements other than as recommended by nutritional counseling provided at study start.
• •Use of prescription medications on a regular basis with the following exceptions:
• •1. Contraceptives (must be on for ≥3 months);
• •2. Hormone replacement therapy (must be on stable dose for ≥3 months);
• •3. Antihypertensives (\<2 medications on a stable dose for ≥ 30 days);
• •4. Statins (dose must be ≤ half the maximum dose; must be on a stable dose ≥3 months);
• •5. Thyroxin (stable dose for ≥ 30 days);
• •6. The last use of any other prescription medication must have been greater than 5 half-lives for the specific medication or at least 14 days prior to randomization, whichever is longer.
• •Women who are pregnant or are breast feeding.
• •Previously randomized and dosed in this study or previously exposed to setmelanotide.
• •History of alcohol or drug abuse within 5 years of Screening Visit.
• •Any other reason, which in the opinion of the Investigator, would confound proper evaluation of the study.