Pulmonary HypertensionPhase 2NCT06616974
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)
A Phase 2 study testing TX000045- Dose A and TX000045- Dose B in people with Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction, run by Tectonic Therapeutic at 72 sites in 17 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 83 years
- Conditions the study is for
- Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
- What is being tested?
- TX000045- Dose A and TX000045- Dose B
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 191 participants
- Where
- 72 sitesin 17 countries
- Study dates
- 4 Sep 2024to 5 Jan 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 83 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
72 sites in 17 countries.
72 sites in 17 countries
United States25 sites
Augusta
Augusta, Georgia, 30912
Aurora
Aurora, Colorado, 80045
Baltimore
Baltimore, Maryland, 21201
Boise
Boise, Idaho, 83706
Boston
Boston, Massachusetts, 02180
Durham
Durham, North Carolina, 27710
Jacksonville
Jacksonville, Florida, 32216
USA
Louisville, Kentucky, 40202
McDonough
McDonough, Georgia, 30253
Minneapolis
Minneapolis, Minnesota, 55414
New York
New York, New York, 10029
New York
New York, New York, 10075
United States
Norfolk, Virginia, 23507
Omaha
Omaha, Nebraska, 68198
Philadelphia
Philadelphia, Pennsylvania, 19107
Phoenix
Phoenix, Arizona, 85283
Pittsburgh
Pittsburgh, Pennsylvania, 15213
Port Arthur
Port Arthur, Texas, 77642
Salt Lake City
Salt Lake City, Utah, 84112
San Francisco
San Francisco, California, 94143
Santa Rosa
Santa Rosa, California, 95405
Scottsdale
Scottsdale, Arizona, 85258
St Louis
St Louis, Missouri, 63110
Waco
Waco, Texas, 76712
York
York, Pennsylvania, 17403
Australia10 sites
Camperdown
Camperdown, New South Wales, 2050
Camperdown
Camperdown, 2050
Chermside
Chermside, Queensland, 4032
Hobart
Hobart, Tasmania, 7000
Macquarie
Macquarie, New South Wales, 2109
Malvern
Malvern, Victoria, 3145
New Lambton
New Lambton, New South Wales, 2305
New Lambton
New Lambton, 2305
Sydney
Sydney, New South Wales, 2010
Wollongong
Wollongong, New South Wales, 2500
Poland6 sites
Białystok
Bialystok, 15-276
Krakow
Krakow, 31-202
Łodź
Lodz, 91-347
Lublin
Lublin, 20-090
Warsaw
Warsaw, 04-628
Wrocław
Wroclaw, 50-556
Spain5 sites
Barcelona
Barcelona, 08035
Madrid
Madrid, 28034
Madrid
Madrid, 28041
Santiago de Compostela ( Coruña )
Santiago de Compostela, 15706
Valencia
Valencia, 46010
Georgia4 sites
Tbilisi
Tbilisi, Tb, 0186
Tbilisi
Tbilisi, 0159
Tbilisi
Tbilisi, 0167
Tbilisi
Tbilisi, 0191
Serbia4 sites
Nis, Belgrade
Belgrade, Nis, 18108
Serbia
Belgrade, 11040
Sremska Kamenica
Kamenitz, 21204
Kragujevac
Kragujevac, 34000
Armenia3 sites
Yerevan
Yerevan, 0006
Yerevan
Yerevan, 0025
Yerevan
Yerevan, 0087
Portugal3 sites
Almada
Almada, 2805-267
Lisboa
Lisbon, 1649-028
Porto
Porto, 4099-001
Romania3 sites
Bucuresti
Bucharest, 022328
Craiova
Craiova, 200642
Targu Mures
Târgu Mureş, 540136
About this study
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)
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).
Read the detailed description
This study will enroll approximately 191 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
- Being tested
- TX000045- Dose A, TX000045- Dose B, Placebo
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TX000045- Dose ADrug
The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.
TX000045- Dose BDrug
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.
PlaceboDrug
The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| TX000045 Dose A | Experimental | Participants will receive a single dose of TX000045 Dose A subcutaneously every 2 weeks for 24 weeks from Day 1 to Day 155. Receives: Drug: TX000045- Dose A |
| TX000045 Dose B | Experimental | 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. Receives: Drug: TX000045- Dose B |
| Placebo | Placebo comparator | Participants will receive a single placebo dose SC for 24 weeks from Day 1 to Day 155 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline up to Week 30 post first dose
Number of participants with abnormal laboratory values and/or adverse events that are related to treatment.
Measured: Baseline up to Week 30 post first dose
Number of participants with treatment-related adverse events.
Measured: Baseline up to Week 30 post first dose
Number of participants with changes in the physical examination findings.
Measured: Baseline to Week 30 post first dose
Secondary outcomes (10)
Mean change from baseline in pulmonary capillary wedge pressure (PCWP).
Measured by RHC between those who received TX000045 and those with placebo.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Day 1, Week 2, Week 4, Week 8, Week 16, Week 24 and Week 30 post first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2024
- Study start4 Sep 2024
- Primary completion24 Nov 2026 (estimated)
- Study completion5 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 191 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tectonic Therapeutic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Rogers, MD, Study director, Tectonic Therapeutic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06616974
- Sponsor's protocol ID
- TX000045-003
- Status last verified
- Mar 2026
- First submitted
- 19 Sep 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No