A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
NCT ID: NCT06616974
Last Updated: 2026-01-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
180 participants
INTERVENTIONAL
2024-09-04
2026-11-20
Brief Summary
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Detailed Description
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* 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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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TX000045 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
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.
TX000045 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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
83 Years
ALL
No
Sponsors
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Tectonic Therapeutic
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Rogers, MD
Role: STUDY_DIRECTOR
Tectonic Therapeutic
Locations
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Phoenix
Phoenix, Arizona, United States
Scottsdale
Scottsdale, Arizona, United States
San Francisco
San Francisco, California, United States
Santa Rosa
Santa Rosa, California, United States
Aurora
Aurora, Colorado, United States
Jacksonville
Jacksonville, Florida, United States
Tampa
Tampa, Florida, United States
Augusta
Augusta, Georgia, United States
McDonough
McDonough, Georgia, United States
Boise
Boise, Idaho, United States
Chicago
Chicago, Illinois, United States
Indianapolis
Indianapolis, Indiana, United States
USA
Louisville, Kentucky, United States
Baltimore
Baltimore, Maryland, United States
Boston
Boston, Massachusetts, United States
Minneapolis
Minneapolis, Minnesota, United States
St Louis
St Louis, Missouri, United States
Omaha
Omaha, Nebraska, United States
New York
New York, New York, United States
New York
New York, New York, United States
Durham
Durham, North Carolina, United States
Toledo
Toledo, Ohio, United States
Philadelphia
Philadelphia, Pennsylvania, United States
Pittsburgh
Pittsburgh, Pennsylvania, United States
York
York, Pennsylvania, United States
Rock Hill
Rock Hill, South Carolina, United States
Port Arthur
Port Arthur, Texas, United States
Waco
Waco, Texas, United States
Salt Lake City
Salt Lake City, Utah, United States
United States
Norfolk, Virginia, United States
Richmond
Richmond, Virginia, United States
Yerevan
Yerevan, , Armenia
Yerevan
Yerevan, , Armenia
Yerevan
Yerevan, , Armenia
Camperdown
Camperdown, New South Wales, Australia
Macquarie
Macquarie, New South Wales, Australia
New Lambton
New Lambton, New South Wales, Australia
Sydney
Sydney, New South Wales, Australia
Wollongong
Wollongong, New South Wales, Australia
Auchenflower
Auchenflower, Queensland, Australia
Chermside
Chermside, Queensland, Australia
Hobart
Hobart, Tasmania, Australia
Malvern
Malvern, Victoria, Australia
Camperdown
Camperdown, , Australia
New Lambton
New Lambton, , Australia
Austria
Vienna, , Austria
Brussel
Brussels, , Belgium
Genk
Genk, , Belgium
Pleven
Pleven, , Bulgaria
Plovdiv
Plovdiv, , Bulgaria
Sofia
Sofia, , Bulgaria
Sofia
Sofia, , Bulgaria
Tbilisi
Tbilisi, Tb, Georgia
Tbilisi
Tbilisi, , Georgia
Tbilisi
Tbilisi, , Georgia
Tbilisi
Tbilisi, , Georgia
Mainz
Mainz, , Germany
Riga
Riga, , Latvia
Chisinau
Chisinau, , Moldova
Christchurch
Christchurch, , New Zealand
Dunedin
Dunedin, , New Zealand
Białystok
Bialystok, , Poland
Krakow
Krakow, , Poland
Łodź
Lodz, , Poland
Lublin
Lublin, , Poland
Warsaw
Warsaw, , Poland
Wrocław
Wroclaw, , Poland
Almada
Almada, , Portugal
Lisboa
Lisbon, , Portugal
Porto
Porto, , Portugal
Bucuresti
Bucharest, , Romania
Craiova
Craiova, , Romania
Targu Mures
Târgu Mureş, , Romania
Nis, Belgrade
Belgrade, Nis, Serbia
Belgrade
Belgrade, , Serbia
Serbia
Belgrade, , Serbia
Sremska Kamenica
Kamenitz, , Serbia
Kragujevac
Kragujevac, , Serbia
Barcelona
Barcelona, , Spain
Madrid
Madrid, , Spain
Madrid
Madrid, , Spain
Santiago de Compostela ( Coruña )
Santiago de Compostela, , Spain
Toledo
Toledo, , Spain
Valencia
Valencia, , Spain
Valencia
Valencia, , Spain
Ukraine
Kyiv, , Ukraine
Countries
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Central Contacts
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Other Identifiers
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TX000045-003
Identifier Type: -
Identifier Source: org_study_id
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