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New drug aims to ease lung pressure in heart failure patients

NCT ID NCT06616974

Disease control Sponsor: Tectonic Therapeutic Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This study tests an experimental drug called TX000045 in 180 adults with pulmonary hypertension (high blood pressure in the lungs) caused by a type of heart failure where the heart pumps normally but doesn't relax properly. Participants will receive either the drug or a placebo for 24 weeks. The main goal is to see if the drug lowers lung blood vessel resistance and is safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 191 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 83 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diastolic heart failure pulmonary hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure with preserved ejection fraction Pulmonary hypertension

Contacts and locations

Locations

  • Almada

    Almada, 2805-267, Portugal

  • Augusta

    Augusta, Georgia, 30912, United States

  • Aurora

    Aurora, Colorado, 80045, United States

  • Austria

    Vienna, 1100, Austria

  • Baltimore

    Baltimore, Maryland, 21201, United States

  • Barcelona

    Barcelona, 08035, Spain

  • Białystok

    Bialystok, 15-276, Poland

  • Boise

    Boise, Idaho, 83706, United States

  • Boston

    Boston, Massachusetts, 02180, United States

  • Brussel

    Brussels, 1070, Belgium

  • Bucuresti

    Bucharest, 022328, Romania

  • Camperdown

    Camperdown, New South Wales, 2050, Australia

  • Camperdown

    Camperdown, 2050, Australia

  • Chermside

    Chermside, Queensland, 4032, Australia

  • Chisinau

    Chisinau, Moldova

  • Christchurch

    Christchurch, 8011, New Zealand

  • Craiova

    Craiova, 200642, Romania

  • Durham

    Durham, North Carolina, 27710, United States

  • Hobart

    Hobart, Tasmania, 7000, Australia

  • Jacksonville

    Jacksonville, Florida, 32216, United States

  • Kragujevac

    Kragujevac, 34000, Serbia

  • Krakow

    Krakow, 31-202, Poland

  • Lisboa

    Lisbon, 1649-028, Portugal

  • Lublin

    Lublin, 20-090, Poland

  • Macquarie

    Macquarie, New South Wales, 2109, Australia

  • Madrid

    Madrid, 28034, Spain

  • Madrid

    Madrid, 28041, Spain

  • Mainz

    Mainz, 55131, Germany

  • Malvern

    Malvern, Victoria, 3145, Australia

  • McDonough

    McDonough, Georgia, 30253, United States

  • Minneapolis

    Minneapolis, Minnesota, 55414, United States

  • New Lambton

    New Lambton, New South Wales, 2305, Australia

  • New Lambton

    New Lambton, 2305, Australia

  • New York

    New York, New York, 10029, United States

  • New York

    New York, New York, 10075, United States

  • Nis, Belgrade

    Belgrade, Nis, 18108, Serbia

  • Omaha

    Omaha, Nebraska, 68198, United States

  • Philadelphia

    Philadelphia, Pennsylvania, 19107, United States

  • Phoenix

    Phoenix, Arizona, 85283, United States

  • Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • Pleven

    Pleven, 5800, Bulgaria

  • Plovdiv

    Plovdiv, 4001, Bulgaria

  • Port Arthur

    Port Arthur, Texas, 77642, United States

  • Porto

    Porto, 4099-001, Portugal

  • Riga

    Riga, LV10002, Latvia

  • Salt Lake City

    Salt Lake City, Utah, 84112, United States

  • San Francisco

    San Francisco, California, 94143, United States

  • Santa Rosa

    Santa Rosa, California, 95405, United States

  • Santiago de Compostela ( Coruña )

    Santiago de Compostela, 15706, Spain

  • Scottsdale

    Scottsdale, Arizona, 85258, United States

  • Serbia

    Belgrade, 11040, Serbia

  • Sremska Kamenica

    Kamenitz, 21204, Serbia

  • St Louis

    St Louis, Missouri, 63110, United States

  • Sydney

    Sydney, New South Wales, 2010, Australia

  • Targu Mures

    Târgu Mureş, 540136, Romania

  • Tbilisi

    Tbilisi, Tb, 0186, Georgia

  • Tbilisi

    Tbilisi, 0159, Georgia

  • Tbilisi

    Tbilisi, 0167, Georgia

  • Tbilisi

    Tbilisi, 0191, Georgia

  • USA

    Louisville, Kentucky, 40202, United States

  • Ukraine

    Kyiv, 01135, Ukraine

  • United States

    Norfolk, Virginia, 23507, United States

  • Valencia

    Valencia, 46010, Spain

  • Waco

    Waco, Texas, 76712, United States

  • Warsaw

    Warsaw, 04-628, Poland

  • Wollongong

    Wollongong, New South Wales, 2500, Australia

  • Wrocław

    Wroclaw, 50-556, Poland

  • Yerevan

    Yerevan, 0006, Armenia

  • Yerevan

    Yerevan, 0025, Armenia

  • Yerevan

    Yerevan, 0087, Armenia

  • York

    York, Pennsylvania, 17403, United States

  • Łodź

    Lodz, 91-347, Poland

More trials for these conditions

Other studies related to the condition(s) this trial covers.