Study of Subcutaneously Administered ENT-03 for the Treatment of Obesity and Diabetes

Exclusion Criteria

• •1. History of excessive alcohol use (defined as \>21 drinks per week for males and \>14 drinks per week for females), recreational drug use within the past three months, or failure on urinary drug screen.
• •2. Pregnant or breastfeeding within six months of screening assessment.
• •3. Substantial changes in eating habits or exercise routine within the preceding three months.
• •4. Evidence of eating disorders.
• •5. \>5% weight change in the past three months.
• •6. Bariatric surgery within the past five years.
• •7. Significant renal impairment (eGFR \<60 mg/mL/1.73m2).
• •8. Patients on anti-diabetic medications other than metformin.
• •9. Patients with gastroparesis.
• •10. Liver function tests (i.e., ALT, AST, alkaline phosphatase) greater than twice the upper limit of normal upon repeated measurements.
• •11. Diseases interfering with metabolism and/or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses).
• •12. History of major depressive disorder within the previous two years, a lifetime history of suicide attempt, suicidal behavior within the previous month, or history of other severe psychiatric disorders.
• •13. Score of \>15 on the Columbia Suicide Severity Rating Scale (C-SSRS).
• •14. Use of medications affecting body weight within the past three months:
• •* Drugs approved for the treatment of obesity
• •* Cyproheptadine or medroxyprogesterone
• •* Atypical anti-psychotic drugs
• •* Tricyclic antidepressants
• •* Lithium, MAO's, glucocorticoids
• •* SSRI's or SNRI's
• •* Antiepileptic drugs
• •15. Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests.
• •16. A baseline prolongation of QT/QTc interval after repeated measurements of \>450 ms; a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmias or torsades de pointes, structural heart disease, or a family history of Long QT Syndrome (LQTS).
• •17. Participation in an investigational drug trial within the month prior to dosing in the present study.