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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
Led by Tectonic Therapeutic · Updated on 2026-03-27
180
Participants Needed
86
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of TX000045 in patients with pulmonary hypertension caused by heart failure with preserved ejection fraction (PH-HFpEF). This is a phase 2, double-blind, randomized, placebo-controlled study designed to compare two different dose regimens of TX000045 over a 24-week treatment period. The study aims to assess changes in pulmonary vascular resistance and safety outcomes among participants. Eligible patients will be randomly assigned to one of three groups: one group will receive a placebo injection every two weeks, the second group will receive TX000045 Dose A by subcutaneous injection every two weeks, and the third group will alternate between TX000045 Dose B and placebo every two weeks. Treatment will continue for 24 weeks from day 1 to day 155. Participants will undergo various assessments including measurements of pulmonary vascular resistance, cardiac output, exercise capacity, and laboratory tests to monitor safety and immune response. Questionnaires about heart failure symptoms will also be completed. Safety will be assessed through monitoring adverse events and physical examinations throughout the study and up to 30 weeks after the first dose. Total participation lasts at least 24 weeks with follow-up visits extending to week 30.
CONDITIONS
Brief Title
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female of non-childbearing potential between 18 and 83 years old
- Diagnosis of pulmonary hypertension secondary to heart failure with preserved ejection fraction based on echocardiogram and right heart catheterization
- New York Heart Association (NYHA) functional class II or III heart failure
- 6-minute walk test distance between 100 and 450 meters
- Stable dose of chronic medication for heart failure or cardiovascular disease prior to screening
- Able to understand and provide written consent for participation
You will not qualify if you...
- Diagnosis of pulmonary hypertension in WHO Groups 1, 3, 4, or 5
- Current or recent hospitalization before screening
- Recent use of vasoactive drugs, pulmonary arterial hypertension therapies, or relaxin receptor agonists
- Starting or planning to start a new exercise program for cardiopulmonary rehabilitation during the study
- Body mass index less than 18 or greater than 45 kg/m²
- Previous treatment with TX000045, relaxin, or relaxin fusion protein
- Significant lung disease, cardiovascular comorbidities, liver disease, infectious disease, or malignancy
- Abnormal lab values during screening including elevated liver enzymes, low kidney function, high HbA1c, low platelet count, or low hemoglobin
- History of allergic reactions to drugs similar to TX000045
- Pregnant or breastfeeding
- History of cancer within 5 years except certain skin or cervical cancers
- History of drug or alcohol abuse
- Recent participation in another clinical research study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants receive subcutaneous injections of TX000045 or placebo every 2 weeks for 24 weeks, according to their assigned treatment group.
Injections every 2 weeks for 24 weeks
Duration - Up to 6 weeks
Participants are monitored for safety and treatment effects after completing the treatment phase.
Visits at Week 24 and Week 30 post first dose
Trial Site Locations
Total: 86 locations
1
Phoenix
Phoenix, Arizona, United States, 85283
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2
Scottsdale
Scottsdale, Arizona, United States, 85258
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3
San Francisco
San Francisco, California, United States, 94143
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4
Santa Rosa
Santa Rosa, California, United States, 95405
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5
Aurora
Aurora, Colorado, United States, 80045
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6
Jacksonville
Jacksonville, Florida, United States, 32216
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7
Tampa
Tampa, Florida, United States, 33613
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8
Augusta
Augusta, Georgia, United States, 30912
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9
McDonough
McDonough, Georgia, United States, 30253
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10
Boise
Boise, Idaho, United States, 83706
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11
Chicago
Chicago, Illinois, United States, 60453
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12
Indianapolis
Indianapolis, Indiana, United States, 46219
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13
USA
Louisville, Kentucky, United States, 40202
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14
Baltimore
Baltimore, Maryland, United States, 21201
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15
Boston
Boston, Massachusetts, United States, 02180
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16
Minneapolis
Minneapolis, Minnesota, United States, 55414
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17
St Louis
St Louis, Missouri, United States, 63110
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18
Omaha
Omaha, Nebraska, United States, 68198
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19
New York
New York, New York, United States, 10029
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20
New York
New York, New York, United States, 10075
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21
Durham
Durham, North Carolina, United States, 27710
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22
Toledo
Toledo, Ohio, United States, 43606
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23
Philadelphia
Philadelphia, Pennsylvania, United States, 19107
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24
Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
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25
York
York, Pennsylvania, United States, 17403
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26
Rock Hill
Rock Hill, South Carolina, United States, 29732
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27
Port Arthur
Port Arthur, Texas, United States, 77642
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28
Waco
Waco, Texas, United States, 76712
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29
Salt Lake City
Salt Lake City, Utah, United States, 84112
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30
United States
Norfolk, Virginia, United States, 23507
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31
Richmond
Richmond, Virginia, United States, 23230
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32
Yerevan
Yerevan, Armenia, 0006
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33
Yerevan
Yerevan, Armenia, 0025
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34
Yerevan
Yerevan, Armenia, 0087
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35
Camperdown
Camperdown, New South Wales, Australia, 2050
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36
Macquarie
Macquarie, New South Wales, Australia, 2109
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37
New Lambton
New Lambton, New South Wales, Australia, 2305
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38
Sydney
Sydney, New South Wales, Australia, 2010
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39
Wollongong
Wollongong, New South Wales, Australia, 2500
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40
Auchenflower
Auchenflower, Queensland, Australia, 4066
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41
Chermside
Chermside, Queensland, Australia, 4032
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42
Hobart
Hobart, Tasmania, Australia, 7000
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43
Malvern
Malvern, Victoria, Australia, 3145
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44
Camperdown
Camperdown, Australia, 2050
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45
New Lambton
New Lambton, Australia, 2305
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46
Austria
Vienna, Austria, 1100
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47
Brussel
Brussels, Belgium, 1070
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48
Genk
Genk, Belgium, 3600
Completed
49
Pleven
Pleven, Bulgaria, 5800
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50
Plovdiv
Plovdiv, Bulgaria, 4001
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51
Sofia
Sofia, Bulgaria, 1700
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52
Sofia
Sofia, Bulgaria, 1750
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53
Tbilisi
Tbilisi, Tb, Georgia, 0186
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54
Tbilisi
Tbilisi, Georgia, 0159
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55
Tbilisi
Tbilisi, Georgia, 0167
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56
Tbilisi
Tbilisi, Georgia, 0191
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57
Mainz
Mainz, Germany, 55131
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58
Riga
Riga, Latvia, LV10002
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59
Chisinau
Chisinau, Moldova
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60
Christchurch
Christchurch, New Zealand, 8011
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61
Dunedin
Dunedin, New Zealand, 9016
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62
Białystok
Bialystok, Poland, 15-276
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63
Krakow
Krakow, Poland, 31-202
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64
Łodź
Lodz, Poland, 91-347
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65
Lublin
Lublin, Poland, 20-090
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66
Warsaw
Warsaw, Poland, 04-628
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67
Wrocław
Wroclaw, Poland, 50-556
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68
Almada
Almada, Portugal, 2805-267
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69
Lisboa
Lisbon, Portugal, 1649-028
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70
Porto
Porto, Portugal, 4099-001
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71
Bucuresti
Bucharest, Romania, 022328
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72
Craiova
Craiova, Romania, 200642
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73
Targu Mures
Târgu Mureş, Romania, 540136
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74
Nis, Belgrade
Belgrade, Nis, Serbia, 18108
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75
Belgrade
Belgrade, Serbia, 11000
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76
Serbia
Belgrade, Serbia, 11040
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77
Sremska Kamenica
Kamenitz, Serbia, 21204
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78
Kragujevac
Kragujevac, Serbia, 34000
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79
Barcelona
Barcelona, Spain, 08035
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80
Madrid
Madrid, Spain, 28034
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81
Madrid
Madrid, Spain, 28041
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82
Santiago de Compostela ( Coruña )
Santiago de Compostela, Spain, 15706
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83
Toledo
Toledo, Spain, 45007
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84
Valencia
Valencia, Spain, 46010
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85
Valencia
Valencia, Spain, 46015
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86
Ukraine
Kyiv, Ukraine, 01135
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Research Team
C
Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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