Study of Ralinepag on Exercise Capacity by Cardiopulmonary Exercise Testing (CPET) in WHO Group 1 PH Subjects

Study ROR-PH-302, ADVANCE CAPACITY, was designed to evaluate the effects of ralinepag therapy on exercise capacity as assessed by change in peak oxygen consumption (VO2) derived from cardiopulmonary exercise testing (CPET) after 28 weeks of treatment.

Inclusion Criteria: 1. Signed informed consent form. 2. At least 18 years of age. 3. Primary diagnosis of PAH. 4. Has had a diagnostic RHC performed at or within 3 years before Screening (or at Screening if one is not available) that is consistent with the diagnosis of PAH. 5. Has World Health Organization (WHO)/New York Heart Association (NYHA) Functional Class (FC) II to III symptoms 6. Must be on a stable dose of PAH-specific oral therapy, defined as no change in dose or regimen for at least 90 days prior to randomization. Allowable PAH-specific therapy is an endothelin receptor antagonist and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a soluble guanylate cyclase (sGC) stimulator. Subjects may be on a stable dose of either a PDE5-I or a sGC stimulator, not both. 7. Has a 6-minute walk distance (6MWD) of ≥150 meters at Screening. 8. Has a peak VO2 of ≥9 to \110 msec, will be excluded if QTcF is \>500 msec for both males and females. 12. Severe chronic liver disease (ie, Child-Pugh Class C), portal hypertension, cirrhosis, or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage, encephalopathy). 13. Confirmed active infection with hepatitis B virus or hepatitis C virus. 14. Subjects with alanine aminotransferase or aspartate aminotransferase ≥3 times the upper limit of normal or total bilirubin ≥2 times the upper limit of normal at Screening. 15. Chronic renal insufficiency as defined by an estimated glomerular filtration rate using the Modification of Diet in Renal Disease Study equation of \