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Clinical Trial NCT06616974 for Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study) Phase 2 180 Randomized Double-Blind Placebo-Controlled
Clinical Trial NCT06616974 is designed to study Treatment for Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction. It is a Phase 2 interventional study that is recruiting, having started on September 4, 2024, with plans to enroll 180 participants. Led by Tectonic Therapeutic, it is expected to complete by November 20, 2026. The latest data from ClinicalTrials.gov was last updated on March 27, 2026.
Brief 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).
Detailed Description
This study will enroll approximately 180 participants and eligible patients will be randomized to one of 3 treatment arms:
- Arm 1: Treatment Group 1: Placebo delivered subcutaneously (SC) every 2 weeks (Q2W) for 24 weeks
- Arm 2: Treatment Group 2: TX000045 SC at Dose A Q2W for 24 weeks
- Arm 3: Treatment Group 3: TX000045 SC at Dose B Q2W alternating with Placebo Q2W for 24 weeks
Official Title
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)
Conditions
Pulmonary HypertensionHeart Failure With Preserved Ejection FractionOther Study IDs
- TX000045-003
NCT ID Number
Start Date (Actual)
2024-09-04
Last Update Posted
2026-03-27
Completion Date (Estimated)
2026-11-20
Enrollment (Estimated)
180
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalTX000045 Dose A Participants will receive a single dose of TX000045 Dose A subcutaneously every 2 weeks for 24 weeks from Day 1 to Day 155. | TX000045- Dose A The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks. |
ExperimentalTX000045 Dose B Participants will receive alternating single doses of TX000045 Dose B and placebo subcutaneously every 2 weeks for 24 weeks from Day 1 to Day 155. | 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 ComparatorPlacebo Participants will receive a single placebo dose SC for 24 weeks from Day 1 to Day 155 | Placebo The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH). | Measured by right heart catheterization (RHC) between those who received TX000045 and those with placebo. | Baseline up to Week 24 post first dose |
Assess safety of TX000045 by the incidence of adverse events, adverse events of special interest and SAEs. | Baseline up to Week 30 post first dose | |
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment. | Baseline up to Week 30 post first dose | |
Number of participants with treatment-related adverse events. | Baseline up to Week 30 post first dose | |
Number of participants with changes in the physical examination findings. | Baseline to Week 30 post first dose |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Mean change from baseline in pulmonary capillary wedge pressure (PCWP). | Measured by RHC between those who received TX000045 and those with placebo. | Baseline to Week 24 post first dose |
Mean change from baseline in PVR for all participants. | Measured by RHC between those who received TX000045 and those with placebo. | Baseline to Week 24 post first dose |
Mean change from baseline in cardiac output (CO) for all participants and in participants with CpcPH. | This is measured by RHC between those who received TX000045 and those with placebo. | Baseline to Week 24 post first dose |
Mean change from baseline in exercise capacity in all participants and in participants with CpcPH. | This is measured by mean change from baseline in 6-minute walk test (6MWT) distance between those who received TX000045 and those with placebo. | Baseline to Week 30 post first dose |
Mean change from baseline in total pulmonary resistance (TPR) for all participants and in participants with CpcPH. | This is measured by RHC between those who received TX000045 and those with placebo. | Baseline to Week 24 post first dose |
Mean change from baseline in mean pulmonary arterial pressure (mPAP) for all participants and in participants with CpcPH. | This is measured by RHC between those who received TX000045 and those with placebo. | Baseline to Week 24 post first dose |
Mean change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP) for all participants and in participants with CpcPH between those who received TX000045 and those with placebo. | Baseline to Week 30 post first dose | |
Mean change from baseline responses on the Kansas City Cardiomyopathy Questionnaire (KCCQ) for all participants and in participants with CpcPH. | To evaluate the effect of TX000045 vs. Placebo on Kansas City Cardiomyopathy Questionnaire (KCCQ) scores. Kansas City Cardiomyopathy Questionnaire (KCCQ-12) is a validated tool to assess quality of life in patients with heart failure. It contains 4 subdomains: physical limitation, symptom frequency, QOL, and social limitations. Each subdomain provides an individual score from 0 to 100, with 0 denoting the worst and 100 the best possible health status. | Baseline to Week 24 post first dose |
Evaluate the incidence of immunogenicity of TX000045 by the number of participants with detectable anti-drug antibody titers. | Day 1, Week 2, Week 4, Week 8, Week 16, Week 24 and Week 30 post first dose | |
Number of participants with change in antibody titers following treatment with TX000045 (Immunogenicity). | Day 1, Week 2, Week 4, Week 8, Week 16, Week 24 and Week 30 post first dose |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
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.
Tectonic TherapeuticStudy Central Contact
Contact: Clinical Trials, +1 339 337 4053, [email protected]
86 Study Locations in 17 Countries
Arizona
Phoenix, Phoenix, Arizona, 85283, United States
Recruiting
Scottsdale, Scottsdale, Arizona, 85258, United States
Recruiting
California
San Francisco, San Francisco, California, 94143, United States
Recruiting
Santa Rosa, Santa Rosa, California, 95405, United States
Recruiting
Colorado
Aurora, Aurora, Colorado, 80045, United States
Recruiting
Florida
Jacksonville, Jacksonville, Florida, 32216, United States
Recruiting
Tampa, Tampa, Florida, 33613, United States
Recruiting
Georgia
Augusta, Augusta, Georgia, 30912, United States
Recruiting
McDonough, McDonough, Georgia, 30253, United States
Recruiting
Idaho
Boise, Boise, Idaho, 83706, United States
Recruiting
Illinois
Chicago, Chicago, Illinois, 60453, United States
Recruiting
Indiana
Indianapolis, Indianapolis, Indiana, 46219, United States
Recruiting
Kentucky
USA, Louisville, Kentucky, 40202, United States
Recruiting
Maryland
Baltimore, Baltimore, Maryland, 21201, United States
Recruiting
Massachusetts
Boston, Boston, Massachusetts, 02180, United States
Recruiting
Minnesota
Minneapolis, Minneapolis, Minnesota, 55414, United States
Recruiting
Missouri
St Louis, St Louis, Missouri, 63110, United States
Recruiting
Nebraska
Omaha, Omaha, Nebraska, 68198, United States
Recruiting
New York
New York, New York, New York, 10029, United States
Recruiting
New York, New York, New York, 10075, United States
Recruiting
North Carolina
Durham, Durham, North Carolina, 27710, United States
Recruiting
Ohio
Toledo, Toledo, Ohio, 43606, United States
Recruiting
Pennsylvania
Philadelphia, Philadelphia, Pennsylvania, 19107, United States
Recruiting
Pittsburgh, Pittsburgh, Pennsylvania, 15213, United States
Recruiting
York, York, Pennsylvania, 17403, United States
Recruiting
South Carolina
Rock Hill, Rock Hill, South Carolina, 29732, United States
Recruiting
Texas
Port Arthur, Port Arthur, Texas, 77642, United States
Recruiting
Waco, Waco, Texas, 76712, United States
Recruiting
Utah
Salt Lake City, Salt Lake City, Utah, 84112, United States
Recruiting
Virginia
United States, Norfolk, Virginia, 23507, United States
Recruiting
Richmond, Richmond, Virginia, 23230, United States
Recruiting
Christchurch, Christchurch, 8011, New Zealand
Recruiting
Dunedin, Dunedin, 9016, New Zealand
Recruiting
Yerevan, Yerevan, 0006, Armenia
Recruiting
Yerevan, Yerevan, 0025, Armenia
Recruiting
Yerevan, Yerevan, 0087, Armenia
Recruiting
New South Wales
Camperdown, Camperdown, New South Wales, 2050, Australia
Recruiting
Macquarie, Macquarie, New South Wales, 2109, Australia
Recruiting
New Lambton, New Lambton, New South Wales, 2305, Australia
Recruiting
Sydney, Sydney, New South Wales, 2010, Australia
Recruiting
Wollongong, Wollongong, New South Wales, 2500, Australia
Recruiting
Queensland
Auchenflower, Auchenflower, Queensland, 4066, Australia
Recruiting
Chermside, Chermside, Queensland, 4032, Australia
Recruiting
Tasmania
Hobart, Hobart, Tasmania, 7000, Australia
Recruiting
Victoria
Malvern, Malvern, Victoria, 3145, Australia
Recruiting
Camperdown, Camperdown, 2050, Australia
Recruiting
New Lambton, New Lambton, 2305, Australia
Recruiting
Austria, Vienna, 1100, Austria
Recruiting
Brussel, Brussels, 1070, Belgium
Recruiting
Genk, Genk, 3600, Belgium
Completed
Pleven, Pleven, 5800, Bulgaria
Recruiting
Plovdiv, Plovdiv, 4001, Bulgaria
Recruiting
Sofia, Sofia, 1700, Bulgaria
Recruiting
Sofia, Sofia, 1750, Bulgaria
Recruiting
Tb
Tbilisi, Tbilisi, Tb, 0186, Georgia
Recruiting
Tbilisi, Tbilisi, 0159, Georgia
Recruiting
Tbilisi, Tbilisi, 0167, Georgia
Recruiting
Tbilisi, Tbilisi, 0191, Georgia
Recruiting
Mainz, Mainz, 55131, Germany
Recruiting
Riga, Riga, LV10002, Latvia
Recruiting
Chisinau, Chisinau, Moldova
Recruiting
Białystok, Bialystok, 15-276, Poland
Recruiting
Krakow, Krakow, 31-202, Poland
Recruiting
Łodź, Lodz, 91-347, Poland
Recruiting
Lublin, Lublin, 20-090, Poland
Recruiting
Warsaw, Warsaw, 04-628, Poland
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Wrocław, Wroclaw, 50-556, Poland
Recruiting
Almada, Almada, 2805-267, Portugal
Recruiting
Lisboa, Lisbon, 1649-028, Portugal
Recruiting
Porto, Porto, 4099-001, Portugal
Recruiting
Bucuresti, Bucharest, 022328, Romania
Recruiting
Craiova, Craiova, 200642, Romania
Recruiting
Targu Mures, Târgu Mureş, 540136, Romania
Recruiting
Nis
Nis, Belgrade, Belgrade, Nis, 18108, Serbia
Recruiting
Belgrade, Belgrade, 11000, Serbia
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Serbia, Belgrade, 11040, Serbia
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Sremska Kamenica, Kamenitz, 21204, Serbia
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Kragujevac, Kragujevac, 34000, Serbia
Recruiting
Barcelona, Barcelona, 08035, Spain
Recruiting
Madrid, Madrid, 28034, Spain
Recruiting
Madrid, Madrid, 28041, Spain
Recruiting
Santiago de Compostela ( Coruña ), Santiago de Compostela, 15706, Spain
Recruiting
Toledo, Toledo, 45007, Spain
Recruiting
Valencia, Valencia, 46010, Spain
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Valencia, Valencia, 46015, Spain
Recruiting
Ukraine, Kyiv, 01135, Ukraine
Recruiting