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)
Tectonic Therapeutic
180 participants
Sep 4, 2024
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria18
- Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
- Current or recent hospitalization prior to screening.
- Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist.
- 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.
- Was previously administered TX000045, relaxin, or a relaxin fusion protein.
- Historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy.
- 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;
- History of hypersensitivity or reactions to drugs with a similar chemical structure or class to TX000045.
- Is pregnant or breastfeeding.
- 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.
- Was recently dosed in any clinical research study.
Interventions
The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.
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.
The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.
Locations(86)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06616974