RecruitingPhase 2NCT06616974

A Study of TX000045 in Patients With Pulmonary Hypertension Secondary to Heart Failure With Preserved Ejection Fraction (the APEX Study)

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)


Sponsor

Tectonic Therapeutic

Enrollment

180 participants

Start Date

Sep 4, 2024

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 YearsMax Age: 83 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called TX000045 in patients who have a specific type of high blood pressure in the lungs (pulmonary hypertension) caused by heart failure where the heart's pumping function is relatively preserved. This condition is hard to treat, and the study aims to find out if the drug can improve symptoms and exercise ability. **You may be eligible if...** - You are between 18 and 83 years old - You have been diagnosed with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF), confirmed by heart ultrasound and a right heart catheterization procedure - Your heart failure symptoms are classified as moderate (NYHA Class II or III) - You can walk between 100 and 450 meters in a 6-minute walk test - Your heart medications have been at a stable dose before the study **You may NOT be eligible if...** - Your pulmonary hypertension is caused by something other than heart failure (e.g., autoimmune disease, lung disease, or blood clots) - You were recently hospitalized - You are currently taking certain pulmonary arterial hypertension drugs or relaxin receptor drugs Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTX000045- Dose A

The participants will receive a subcutaneous injection of Dose A of TX000045 every 2 weeks for 24 weeks.

DRUGTX000045- 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.

DRUGPlacebo

The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.


Locations(86)

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

Chicago

Chicago, Illinois, United States

Indianapolis

Indianapolis, Indiana, United States

USA

Louisville, Kentucky, United States

Baltimore

Baltimore, Maryland, United States

Boston

Boston, Massachusetts, United States

Minneapolis

Minneapolis, Minnesota, United States

St Louis

St Louis, Missouri, United States

Omaha

Omaha, Nebraska, United States

New York

New York, New York, United States

New York

New York, New York, United States

Durham

Durham, North Carolina, United States

Toledo

Toledo, Ohio, United States

Philadelphia

Philadelphia, Pennsylvania, United States

Pittsburgh

Pittsburgh, Pennsylvania, United States

York

York, Pennsylvania, United States

Rock Hill

Rock Hill, South Carolina, United States

Port Arthur

Port Arthur, Texas, United States

Waco

Waco, Texas, United States

Salt Lake City

Salt Lake City, Utah, United States

United States

Norfolk, Virginia, United States

Richmond

Richmond, Virginia, United States

Yerevan

Yerevan, Armenia

Yerevan

Yerevan, Armenia

Yerevan

Yerevan, Armenia

Camperdown

Camperdown, New South Wales, Australia

Macquarie

Macquarie, New South Wales, Australia

New Lambton

New Lambton, New South Wales, Australia

Sydney

Sydney, New South Wales, Australia

Wollongong

Wollongong, New South Wales, Australia

Auchenflower

Auchenflower, Queensland, Australia

Chermside

Chermside, Queensland, Australia

Hobart

Hobart, Tasmania, Australia

Malvern

Malvern, Victoria, Australia

Camperdown

Camperdown, Australia

New Lambton

New Lambton, Australia

Austria

Vienna, Austria

Brussel

Brussels, Belgium

Genk

Genk, Belgium

Pleven

Pleven, Bulgaria

Plovdiv

Plovdiv, Bulgaria

Sofia

Sofia, Bulgaria

Sofia

Sofia, Bulgaria

Tbilisi

Tbilisi, Tb, Georgia

Tbilisi

Tbilisi, Georgia

Tbilisi

Tbilisi, Georgia

Tbilisi

Tbilisi, Georgia

Mainz

Mainz, Germany

Riga

Riga, Latvia

Chisinau

Chisinau, Moldova

Christchurch

Christchurch, New Zealand

Dunedin

Dunedin, New Zealand

Białystok

Bialystok, Poland

Krakow

Krakow, Poland

Łodź

Lodz, Poland

Lublin

Lublin, Poland

Warsaw

Warsaw, Poland

Wrocław

Wroclaw, Poland

Almada

Almada, Portugal

Lisboa

Lisbon, Portugal

Porto

Porto, Portugal

Bucuresti

Bucharest, Romania

Craiova

Craiova, Romania

Targu Mures

Târgu Mureş, Romania

Nis, Belgrade

Belgrade, Nis, Serbia

Belgrade

Belgrade, Serbia

Serbia

Belgrade, Serbia

Sremska Kamenica

Kamenitz, Serbia

Kragujevac

Kragujevac, Serbia

Barcelona

Barcelona, Spain

Madrid

Madrid, Spain

Madrid

Madrid, Spain

Santiago de Compostela ( Coruña )

Santiago de Compostela, Spain

Toledo

Toledo, Spain

Valencia

Valencia, Spain

Valencia

Valencia, Spain

Ukraine

Kyiv, Ukraine

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NCT06616974


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