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A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)

NCT06616974 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2026-03-27

No results posted yet for this 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).

Conditions

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.

Sponsors & Collaborators

  • Tectonic Therapeutic

    lead INDUSTRY

Principal Investigators

  • Robert Rogers, MD · Tectonic Therapeutic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
83 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-04
Primary Completion
2026-10-09
Completion
2026-11-20
FDA Drug
Yes

Countries

  • United States
  • Armenia
  • Australia
  • Austria
  • Belgium
  • Bulgaria
  • Georgia
  • Germany
  • Latvia
  • Moldova
  • New Zealand
  • Poland
  • Portugal
  • Romania
  • Serbia
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06616974 on ClinicalTrials.gov