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NCT06616974 · ClinicalTrials.gov registry record · Phase 2
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
A Phase 2 study of Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction, sponsored by Tectonic Therapeutic.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 180
- Enrollment target
- 20
- Study locations
NCT06616974: Recruiting Phase 2 study of Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction, sponsored by Tectonic Therapeutic.
NCT06616974 is a Phase 2 study of Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction that is actively recruiting participants, run by Tectonic Therapeutic. The registered enrollment target is 180 participants, below the 611-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06616974, a Phase 2 study of Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction, is actively recruiting participants, sponsored by Tectonic Therapeutic.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 180 participants
- Enrollment target
- 20
- Study locations
Study 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).
Primary Outcome
Measured by right heart catheterization (RHC) between those who received TX000045 and those with placebo.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG TX000045- Dose A
- DRUG TX000045- Dose B
Study Locations (20)
Arizona
- Phoenix - Phoenix
- Scottsdale - Scottsdale
California
- San Francisco - San Francisco
- Santa Rosa - Santa Rosa
Florida
- Jacksonville - Jacksonville
- Tampa - Tampa
Georgia
- Augusta - Augusta
- McDonough - McDonough
New York
- New York - New York
- New York - New York
Colorado
- Aurora - Aurora
Idaho
- Boise - Boise
Illinois
- Chicago - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2024-09-04 |
| Est. Completion | 2026-11-20 |
| Phase | Phase 2 |
What NCT06616974 shows while recruiting
NCT06616974 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 611-participant average among 72 other Pulmonary Hypertension trials with a reported enrollment target (71% lower).
The record links to 2 conditions, with Pulmonary Hypertension appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06616974 names 20 study sites across 15 states, led by Arizona, California, Florida.
Frequently Asked Questions
What is clinical trial NCT06616974 about?
NCT06616974 is a clinical study titled "A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)". 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).
What is the current status of trial NCT06616974?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2024-09-04. Estimated completion is 2026-11-20.
What conditions does trial NCT06616974 study?
This clinical trial studies the following conditions: Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction.
What interventions are being tested in trial NCT06616974?
The interventions under investigation include: Placebo (DRUG), TX000045- Dose A (DRUG), TX000045- Dose B (DRUG).
Who is sponsoring clinical trial NCT06616974?
This trial is sponsored by Tectonic Therapeutic, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06616974 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pulmonary Hypertension
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06616974's enrollment target sits among peer trials
180 25th of 72 higher than 48 of 72 other Pulmonary Hypertension trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pulmonary Hypertension trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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