The primary objective is to assess the safety and tolerability of oral dose ERX1000 in obese subjects.
Able to comprehend and willing to sign an ICF and to abide by the study requirements.
Male and female subjects ages 18-60 years, inclusive.
BMI >30 to <50 kg/m2
Stable body weight for 3 months (self-reported loss/gain <5%).
Poorly controlled severe psychiatric disorders (e.g., bipolar disorder, or major depressive disorder), recent (within 6 months) psychotic episodes, history of suicide attempts or suicidal ideation, or any other psychiatric disorders that the Investigator believes will interfere significantly with study compliance.
Lifetime history of DSM-5 diagnosis of schizophrenia or schizoaffective disorder. Diagnosis of bipolar 1 disorder within the previous 2 years.
History of any bleeding disorders, deep vein thrombosis (DVT), or thromboembolic disease.
Significant cardiovascular disease including history of congestive heart failure (CHF), coronary artery disease, myocardial infarction (MI), second degree or greater heart block, prolonged time from electrocardiogram Q wave to the end of the T wave corresponding to electrical systole (QT) syndrome, or clinically significant arrhythmias.
ERX Pharmaceuticals
Lead sponsor