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Clinical Trials in the USA / NCT06616974
Active, not recruiting Phase 2

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

NCT06616974 · tracked via the Priya Life Science USA tracker
Sponsor
Tectonic Therapeutic
Phase
Phase 2
Started
2024-09-04
Last updated
2026-07-07

Condition(s) studied

Pulmonary HypertensionHeart Failure With Preserved Ejection Fraction

Investigational drug(s) / intervention(s)

TX000045- Dose ATX000045- Dose BPlacebo

TX000045- Dose A: The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.

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.

Placebo: The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
83 Years
Healthy volunteers
No
Inclusion Criteria: 1. Is a male or female of non-childbearing potential between the ages of 18 and 83 years. 2. Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (RHC). 3. Has NYHA functional class II- III heart failure. 4. Has 6MWT distance from 100 to 450m. 5. Chronic medication for heart failure or cardiovascular disease is at a stable dose prior to screening. 6. Is able to understand and provide documented consent for participation. Exclusion Criteria: 1. Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5. 2. Current or recent hospitalization prior to screening. 3. Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist. 4. Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study. 5. Has a body mass index \<18 kg/meter square or \>45 kg/ meter square. 6. Was previously administered TX000045, relaxin, or a relaxin fusion protein. 7. Historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy. 8. Has any of the following clinical laboratory values during screening: 1. Serum alanine aminotransferase or aspartate aminotransferase levels \> 3 x the upper limit of normal (ULN) or total bilirubin \> 3 x ULN; 2. eGFR \<30 mL/min/1.73 m2; 3. HbA1c (glycosylated hemoglobin) \>9%; 4. Platelet count \<50,000/millimeter cube; 5. Hemoglobin \<10.0g/dL; 9. History of hypersensitivity or reactions to drugs with a similar chemical structure or class to TX000045. 10. Is pregnant or breastfeeding. 11. Has a history of cancer within 5 years of screening other than basal cell carcinoma, cervical carcinoma, or squamous cell carcinomas of the skin. 12. Has a history of drug or alcohol abuse. 13. Was recently dosed in any clinical research study.

Primary outcome measure(s)

Trial sites (72)

FacilityCityRegionStatus
Phoenix Phoenix Arizona
Scottsdale Scottsdale Arizona
San Francisco San Francisco California
Santa Rosa Santa Rosa California
Aurora Aurora Colorado
Jacksonville Jacksonville Florida
Augusta Augusta Georgia
McDonough McDonough Georgia
Boise Boise Idaho
USA Louisville Kentucky
Baltimore Baltimore Maryland
Boston Boston Massachusetts
Minneapolis Minneapolis Minnesota
St Louis St Louis Missouri
Omaha Omaha Nebraska
New York New York New York
New York New York New York
Durham Durham North Carolina
Philadelphia Philadelphia Pennsylvania
Pittsburgh Pittsburgh Pennsylvania
York York Pennsylvania
Port Arthur Port Arthur Texas
Waco Waco Texas
Salt Lake City Salt Lake City Utah
United States Norfolk Virginia
Yerevan Yerevan Armenia
Yerevan Yerevan Armenia
Yerevan Yerevan Armenia
Camperdown Camperdown New South Wales
Macquarie Macquarie New South Wales
New Lambton New Lambton New South Wales
Sydney Sydney New South Wales
Wollongong Wollongong New South Wales
Chermside Chermside Queensland
Hobart Hobart Tasmania
Malvern Malvern Victoria
Camperdown Camperdown Australia
New Lambton New Lambton Australia
Austria Vienna Austria
Brussel Brussels Belgium

+ 32 more sites — see the full list on the official registry below.

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06616974 on ClinicalTrials.gov ↗ ← All trials in the USA