A Phase 2A, Randomized, Double-Blind, Placebo-Controlled, Clinical Study to Assess Efficacy, Safety and Tolerability of Orally Administered ERX1000 in Subjects With Obesity
ERX Pharmaceuticals
Summary
The primary objective is to assess the safety and tolerability of oral dose ERX1000 in obese subjects.
Eligibility
- Age range
- 18–60 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Able to comprehend and willing to sign an ICF and to abide by the study requirements. 2. Male and female subjects ages 18-60 years, inclusive. 3. BMI \>30 to \<50 kg/m2 4. Stable body weight for 3 months (self-reported loss/gain \<5%). 5. Stable diet and/or nutritional lifestyle for 3 months prior to randomization. 6. If a subject has current diagnosis of prediabetes, the following criteria must be met: 1. Hemoglobin A1c (HbA1c) ≤6.4% 2. Fasting glucose ≤125 mg/dL (≤6.94 mmol/L) 3. No history of ketoacidosis or hyperosmolar coma 7. Female subjects must not be…
Interventions
- DrugERX1000
2mg tablet administered orally twice weekly.
- OtherPlacebo
2mg Placebo tablet identical in appearance to 2mg ERX1000 tablet
Locations (3)
- Monroe Biomedical ResearchLouisville, Kentucky
- Monroe Biomedical ResearchMonroe, North Carolina
- Monroe Biomedical ResearchNorth Charleston, South Carolina