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)
Study tests new drug TX000045 for a specific type of heart and lung condition.
Plain English Summary
A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study) is a Phase 2 clinical trial sponsored by Tectonic Therapeutic studying Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction. This study is testing if a new drug called TX000045 is safe and effective for people with pulmonary hypertension related to heart failure with preserved ejection fraction. It is for adults aged 18-83 who have been diagnosed with this specific condition and have certain limitations in their daily activities. Participants will receive either TX000045 or a placebo (a dummy treatment) through injections for 24 weeks, with regular check-ups. Alternative treatments may include medications to manage heart failure symptoms, diuretics to reduce fluid buildup, and lifestyle changes. The trial aims to enroll 180 participants.
Official 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).
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 83 years old and have been diagnosed with pulmonary hypertension secondary to heart failure with preserved ejection fraction. You must have a certain level of heart failure (NYHA class II-III) and a walking distance between 100 and 450 meters. You cannot join if you have other specific types of pulmonary hypertension, have recently been hospitalized, or have certain other medical conditions or lab values. Women who can become pregnant and men who are not of non-childbearing potential cannot participate, and you must not be pregnant or breastfeeding. This trial is studying Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures will show if TX000045 can reduce pressure in the blood vessels of the lungs, which is a key problem in this condition, and assess its overall safety. The specific primary outcome measures are: Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH). (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). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.
Why This Trial Matters
This trial addresses a significant unmet need for treatments that can improve the quality of life for patients suffering from pulmonary hypertension linked to heart failure with preserved ejection fra Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction, where improved treatment options are needed.
Investor Insight
This trial represents an early-stage investment in a potentially novel therapy for a large patient population with limited treatment options, suggesting a significant market opportunity if successful. Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor about the potential benefits and risks of joining this study, and what the treatment involves. Participation will require regular visits for injections and medical assessments over a 24-week period. Be prepared to discuss your current medications and any other health conditions you may have. This trial is currently recruiting participants. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: DOUBLE
- Enrollment: 180 participants
Interventions
- DRUG: TX000045- Dose A — The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.
- DRUG: 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.
- DRUG: Placebo — The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.
Primary Outcomes
- Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH). (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)
Secondary Outcomes
- Mean change from baseline in pulmonary capillary wedge pressure (PCWP). (Baseline to Week 24 post first dose)
- Mean change from baseline in PVR for all participants. (Baseline to Week 24 post first dose)
- Mean change from baseline in cardiac output (CO) for all participants and in participants with CpcPH. (Baseline to Week 24 post first dose)
- Mean change from baseline in exercise capacity in all participants and in participants with CpcPH. (Baseline to Week 30 post first dose)
- Mean change from baseline in total pulmonary resistance (TPR) for all participants and in participants with CpcPH. (Baseline to Week 24 post first dose)
Trial Locations
- 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
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT06616974?
NCT06616974 is a Phase 2 INTERVENTIONAL study titled "A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)." It is currently recruiting and is sponsored by Tectonic Therapeutic. The trial targets enrollment of 180 participants.
What conditions does NCT06616974 study?
This trial investigates treatments for Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction. The primary condition under study is Pulmonary Hypertension.
What treatments are being tested in NCT06616974?
The interventions being studied include: TX000045- Dose A (DRUG), TX000045- Dose B (DRUG), Placebo (DRUG). The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.
What does Phase 2 mean for NCT06616974?
Phase 2 trials test whether the treatment works for the intended condition. They involve 100-300 patients and continue to evaluate safety while measuring effectiveness.
What is the current status of NCT06616974?
This trial is currently "Recruiting." It started on 2024-09-04. The estimated completion date is 2026-11-20.
Who is sponsoring NCT06616974?
NCT06616974 is sponsored by Tectonic Therapeutic. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT06616974?
The trial aims to enroll 180 participants. The trial is currently recruiting and accepting new participants.
How is NCT06616974 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs double masking. Masking means some participants and/or investigators do not know which treatment group a participant is in, which helps reduce bias.
What are the primary outcomes being measured in NCT06616974?
The primary outcome measures are: Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH). (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). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT06616974 being conducted?
This trial is being conducted at 20 sites, including Phoenix, Arizona; Scottsdale, Arizona; San Francisco, California; Santa Rosa, California and 16 more sites (United States).
Where can I find official information about NCT06616974?
The official record for NCT06616974 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT06616974. This government database provides the most up-to-date and detailed information about the trial.
What is NCT06616974 testing in simple terms?
This study is testing if a new drug called TX000045 is safe and effective for people with pulmonary hypertension related to heart failure with preserved ejection fraction. It is for adults aged 18-83 who have been diagnosed with this specific condition and have certain limitations in their daily activities.
Why is this trial significant?
This trial addresses a significant unmet need for treatments that can improve the quality of life for patients suffering from pulmonary hypertension linked to heart failure with preserved ejection fra
What are the potential risks of participating in NCT06616974?
Common side effects may include injection site reactions, headache, or dizziness. More serious risks, though less common, could involve changes in blood pressure or heart rhythm, or allergic reactions. The study will closely monitor for any adverse events to ensure patient safety. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT06616974?
Ask your doctor about the potential benefits and risks of joining this study, and what the treatment involves. Participation will require regular visits for injections and medical assessments over a 24-week period. Be prepared to discuss your current medications and any other health conditions you may have. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT06616974 signal from an investment perspective?
This trial represents an early-stage investment in a potentially novel therapy for a large patient population with limited treatment options, suggesting a significant market opportunity if successful. This is a Phase 2 trial, which is focused on confirming efficacy before larger pivotal studies.
What happens if the treatment in this trial doesn't work?
Participants will receive either TX000045 or a placebo (a dummy treatment) through injections for 24 weeks, with regular check-ups. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Pulmonary Hypertension Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.