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TX000045 for Pulmonary Hypertension

Phase 2
Recruiting
Research Sponsored by Tectonic Therapeutic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (RHC)
Is a male or female of non-childbearing potential between the ages of 18 and 80 years
Must not have
Current or recent hospitalization prior to screening
Has a body mass index <18 kg/meter square or >45 kg/meter square
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 30 post first dose

Summary

"This trial is testing a new drug, TX000045, to see if it works for a certain condition. It will last for 24 weeks and involve two different doses of the drug."

Who is the study for?
This trial is for adults aged 18-80 with pulmonary hypertension secondary to heart failure who can walk a certain distance and have stable heart medication. They must not be pregnant, planning intense new exercise, or have recent drug abuse history or hospitalization.
What is being tested?
The APEX study tests two doses of TX000045 against a placebo over 24 weeks in patients with specific types of heart failure and high blood pressure. It's designed to see if the drug is effective (proof-of-concept) and participants are randomly assigned to groups.
What are the potential side effects?
While the side effects aren't listed here, similar trials may include risks like liver function changes, kidney issues, blood sugar fluctuations, fatigue, digestive problems or allergic reactions based on exclusion criteria related to health status.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with heart failure with preserved ejection fraction (HFpEF) based on heart tests.
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I am between 18 and 80 years old and cannot have children.
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I can walk between 100 to 450 meters in six minutes.
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I have moderate heart failure.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I was recently hospitalized.
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My BMI is either below 18 or above 45.
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I have previously been treated with TX000045, relaxin, or a relaxin fusion protein.
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I have recently taken medication for high blood pressure in my lungs.
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I have had cancer other than skin or cervical cancer.
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My condition is diagnosed as pulmonary hypertension in one of the specified WHO groups.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 30 post first dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 30 post first dose for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline on mean Pulmonary Vascular Resistance (PVR) in participants with pulmonary hypertension secondary to heart failure with preserved ejection fraction (PH-HFpEF)
Secondary study objectives
Change from baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP) in participants with PH-HFpEF.
Change from baseline in Pulmonary capillary wedge pressure (PCWP) in patients who received TX000045 vs Placebo.
Change from baseline in mean pulmonary arterial pressure (mPAP) in participants who received TX000045 vs Placebo.
+4 more

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: TX000045 Dose BExperimental Treatment1 Intervention
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.
Group II: TX000045 Dose AExperimental Treatment1 Intervention
Participants will receive a single dose of TX000045 Dose A subcutaneously every 2 weeks for 24 weeks from Day 1 to Day 155.
Group III: PlaceboPlacebo Group1 Intervention
Participants will receive a single placebo dose SC for 24 weeks from Day 1 to Day 155

Find a Location

Who is running the clinical trial?

Tectonic TherapeuticLead Sponsor
Marcie Ruddy, MDStudy DirectorTectonic Therapeutic
~120 spots leftby Oct 2026
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