Subcutaneously Administered MD-18 for the Treatment of Obesity and Diabetes

Exclusion Criteria22

• 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. Note: use of Cannabinoids for medical purposes is allowed.
• Pregnant or breastfeeding within six months of screening assessment.
• Substantial changes in eating habits or exercise routine within the preceding three months.
• Evidence of eating disorders.
• >5% weight change in the past three months.
• Bariatric surgery within the past five years.
• Moderate renal impairment ( Glomerular filtration rate<60 mg/mL/1.73m2)
• Liver function tests greater than twice the upper limit of normal upon repeated measurements.
• Diseases interfering with metabolism and or ingestive behavior (e.g., myxedema, Cushing's disease, schizophrenia, major psychoses, unmanaged depression).
• Use of medications affecting body weight within the past three months, unless on a stable dose, with weight stability in the preceding three months. These medications include:
• Drugs approved for the treatment of obesity
• Cyproheptadine or medroxyprogesterone
• Atypical anti-psychotic drugs
• Tricyclic antidepressants
• Lithium, MAO's, glucocorticoids
• SSRIs or SNRIs
• Anti-epileptic drugs
• Any clinically significant abnormality following the Investigator's review of the physical examination and clinical laboratory tests.
• A baseline (screening echocardiogram result) prolongation of ventricular activation and recovery interval after repeated measurements of >450 milliseconds; 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.
• Use drugs of abuse within the preceding three months.
• The last dose of an investigational drug in other clinical trial was within the month prior to dosing in the present study. Note: Volunteers from the previous Phase 1a trial (MD-18-01) may be recruited for the current study, provided that at least 12 weeks have passed since their last dose of the investigational product.
• A positive result for any of the following tests: hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency viruses (HIV) and Treponema pallidum.