NCT06616974Active, not recruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 7 Jul 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 191 (estimated)
- First submitted
- 19 Sept 2024
- Start date
- 4 Sept 2024
- Primary completion date
- 24 Nov 2026
- Lead sponsor
- Tectonic Therapeutic
- NCT number
- NCT06616974
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 191
- From 4 Sept 2024 to the primary completion date, 24 Nov 2026
- 63 sites in 17 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current or recent hospitalization prior to screening.
- Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist.
- Was previously administered TX000045, relaxin, or a relaxin fusion protein.
Other illness
- Historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy.
- History of hypersensitivity or reactions to drugs with a similar chemical structure or class to TX000045.
- Has a history of cancer within 5 years of screening other than basal cell carcinoma, cervical carcinoma, or squamous cell carcinomas of the skin.
- Has a history of drug or alcohol abuse.
Lab values
- Has any of the following clinical laboratory values during screening:
- Serum alanine aminotransferase or aspartate aminotransferase levels \> 3 x the upper limit of normal (ULN) or total bilirubin \> 3 x ULN;
- eGFR \<30 mL/min/1.73 m2;
- HbA1c (glycosylated hemoglobin) \>9%;
- Platelet count \<50,000/millimeter cube;
- Hemoglobin \<10.0g/dL;
Other
- Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
- Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study.
- Has a body mass index \<18 kg/meter square or \>45 kg/ meter square.
- Is pregnant or breastfeeding.
- Was recently dosed in any clinical research study.
Who the study is looking for
- 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.
- Chronic medication for heart failure or cardiovascular disease is at a stable dose prior to screening.
- Is able to understand and provide documented consent for participation.
Age in the registry: 18 years to 83 years · Sex: All · Does not accept healthy volunteers
Sites (63)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.