TX000045-003 is a double-blind, randomized, parallel group, placebo-controlled, proof- of-concept (POC) study, evaluating 2 dose regimens of TX000045 over the course of a 24-week treatment period (the APEX study).
Is a male or female of non-childbearing potential between the ages of 18 and 83 years.
Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (RHC).
Has NYHA functional class II- III heart failure.
Has 6MWT distance from 100 to 450m.
Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
Current or recent hospitalization prior to screening.
Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist.
Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study.
Parallel
TX000045- Dose A
DrugThe participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.
TX000045- Dose B
DrugThe participants will receive subcutaneous injection of Dose B of TX000045 every 4 weeks for 24 weeks where they will alternate between TX000045 and placebo every 2 weeks.
Placebo
DrugThe participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.
Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH).
Measured by right heart catheterization (RHC) between those who received TX000045 and those with placebo.
Assess safety of TX000045 by the incidence of adverse events, adverse events of special interest and SAEs.
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
Number of participants with treatment-related adverse events.
Mean change from baseline in pulmonary capillary wedge pressure (PCWP).
Measured by RHC between those who received TX000045 and those with placebo.
Mean change from baseline in PVR for all participants.
Measured by RHC between those who received TX000045 and those with placebo.
Mean change from baseline in cardiac output (CO) for all participants and in participants with CpcPH.
This is measured by RHC between those who received TX000045 and those with placebo.
Mean change from baseline in exercise capacity in all participants and in participants with CpcPH.
This is measured by mean change from baseline in 6-minute walk test (6MWT) distance between those who received TX000045 and those with placebo.
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