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Evaluating TX000045 for Pulmonary Hypertension Related to Heart Failure

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)

Phase 2 Interventional Tectonic Therapeutic · NCT06616974

This study is testing if a new drug called TX000045 can help people with pulmonary hypertension caused by heart failure feel better and improve their ability to exercise.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years to 83 Years
SexAll
SponsorTectonic Therapeutic Industry-sponsored
Locations86 sites (Phoenix, Arizona and 85 other locations)
Trial IDNCT06616974 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy of TX000045 in patients suffering from pulmonary hypertension secondary to heart failure with preserved ejection fraction. It is a double-blind, randomized, placebo-controlled trial involving approximately 180 participants who will be assigned to one of three treatment arms over a 24-week period. Participants will receive either a placebo or one of two doses of TX000045 administered subcutaneously every two weeks. The study aims to assess the drug's potential benefits in improving heart function and exercise capacity.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 83 with a diagnosis of pulmonary hypertension secondary to heart failure and specific functional limitations.

Not a fit: Patients with other forms of pulmonary hypertension or those recently hospitalized may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the quality of life and exercise capacity for patients with pulmonary hypertension related to heart failure.

How similar studies have performed: Previous studies have shown promise in treating pulmonary hypertension with similar approaches, but this specific treatment is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Is a male or female of non-childbearing potential between the ages of 18 and 83 years.
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:

1. Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
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.

Where this trial is running

Phoenix, Arizona and 85 other locations

+36 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Pulmonary HypertensionHeart Failure With Preserved Ejection Fraction
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.