Trials / Recruiting
RecruitingNCT06616974
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
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)
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 180 (estimated)
- Sponsor
- Tectonic Therapeutic · Industry
- Sex
- All
- Age
- 18 Years – 83 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
This study will enroll approximately 180 participants and eligible patients will be randomized to one of 3 treatment arms: * Arm 1: Treatment Group 1: Placebo delivered subcutaneously (SC) every 2 weeks (Q2W) for 24 weeks * Arm 2: Treatment Group 2: TX000045 SC at Dose A Q2W for 24 weeks * Arm 3: Treatment Group 3: TX000045 SC at Dose B Q2W alternating with Placebo Q2W for 24 weeks
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-09-04
- Primary completion
- 2026-10-09
- Completion
- 2026-11-20
- First posted
- 2024-09-27
- Last updated
- 2026-03-27
Locations
86 sites across 17 countries: United States, Armenia, Australia, Austria, Belgium, Bulgaria, Georgia, Germany, Latvia, Moldova, New Zealand, Poland, Portugal, Romania, Serbia, Spain, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06616974. Inclusion in this directory is not an endorsement.