A Phase 2, Double-blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of TX000045 After 24 Weeks of Treatment in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (PH-HFpEF)

Summary

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).

Description

Eligibility

Age range

18–83 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  TX000045- Dose A

  The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.

• Drug
  TX000045- Dose B

  The 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.

• Drug
  Placebo

  The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.

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