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

NCT06616974 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: TX000045-003
• Study Type: interventional
• Target: 180
• Locations: 16 countries
• Sites: 75

Brief 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).

Conditions

Pulmonary Hypertension; Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (5)

• Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH).

  Measured by right heart catheterization (RHC) between those who received TX000045 and those with placebo.

  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 (10)

• 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

Study Arms (3)

TX000045 Dose A

EXPERIMENTAL

Participants will receive a single dose of TX000045 Dose A subcutaneously every 2 weeks for 24 weeks from Day 1 to Day 155.

Drug: TX000045- Dose A

TX000045 Dose B

EXPERIMENTAL

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.

Drug: TX000045- Dose B

Placebo

PLACEBO COMPARATOR

Participants will receive a single placebo dose SC for 24 weeks from Day 1 to Day 155

Drug: Placebo

Interventions

TX000045- Dose A DRUG

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

TX000045 Dose A

TX000045- Dose B DRUG

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.

TX000045 Dose B

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 83 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is a male or female of non-childbearing potential between the ages of 18 and 83 years.
• Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heart catheterization (RHC).
• Has NYHA functional class II- III heart failure.
• Has 6MWT distance from 100 to 450m.
• Chronic medication for heart failure or cardiovascular disease is at a stable dose prior to screening.
• Is able to understand and provide documented consent for participation.

You may not qualify if:

• Diagnosis of PH in World Health Organization (WHO) Group 1, WHO Group 3, WHO Group 4, or WHO Group 5.
• Current or recent hospitalization prior to screening.
• Recently received vasoactive drugs, pulmonary arterial hypertension-specific therapies, or a relaxin receptor agonist.
• Initiated a new exercise program for cardiopulmonary rehabilitation or plans to initiate such a program during the study.
• Has a body mass index \<18 kg/meter square or \>45 kg/ meter square.
• Was previously administered TX000045, relaxin, or a relaxin fusion protein.
• Historical or current evidence of a clinically significant disease or disorder such as significant lung disease, cardiovascular comorbitiies, liver disease, infectious disease, or malignancy.
• Has any of the following clinical laboratory values during screening:
• Serum alanine aminotransferase or aspartate aminotransferase levels \> 3 x the upper limit of normal (ULN) or total bilirubin \> 3 x ULN;
• eGFR \<30 mL/min/1.73 m2;
• HbA1c (glycosylated hemoglobin) \>9%;
• Platelet count \<50,000/millimeter cube;
• Hemoglobin \<10.0g/dL;
• History of hypersensitivity or reactions to drugs with a similar chemical structure or class to TX000045.
• Is pregnant or breastfeeding.

Sponsors & Collaborators

• Tectonic Therapeutic: lead

Study Sites (86)

Phoenix

Phoenix, Arizona, 85283, United States

RECRUITING

Scottsdale

Scottsdale, Arizona, 85258, United States

RECRUITING

San Francisco

San Francisco, California, 94143, United States

RECRUITING

Santa Rosa

Santa Rosa, California, 95405, United States

RECRUITING

Aurora

Aurora, Colorado, 80045, United States

RECRUITING

Jacksonville

Jacksonville, Florida, 32216, United States

RECRUITING

Tampa

Tampa, Florida, 33613, United States

RECRUITING

Augusta

Augusta, Georgia, 30912, United States

RECRUITING

McDonough

McDonough, Georgia, 30253, United States

RECRUITING

Boise

Boise, Idaho, 83706, United States

RECRUITING

Chicago

Chicago, Illinois, 60453, United States

RECRUITING

Indianapolis

Indianapolis, Indiana, 46219, United States

RECRUITING

USA

Louisville, Kentucky, 40202, United States

RECRUITING

Baltimore

Baltimore, Maryland, 21201, United States

RECRUITING

Boston

Boston, Massachusetts, 02180, United States

RECRUITING

Minneapolis

Minneapolis, Minnesota, 55414, United States

RECRUITING

St Louis

St Louis, Missouri, 63110, United States

RECRUITING

Omaha

Omaha, Nebraska, 68198, United States

RECRUITING

New York

New York, New York, 10029, United States

RECRUITING

New York

New York, New York, 10075, United States

RECRUITING

Durham

Durham, North Carolina, 27710, United States

RECRUITING

Toledo

Toledo, Ohio, 43606, United States

RECRUITING

Philadelphia

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

York

York, Pennsylvania, 17403, United States

RECRUITING

Rock Hill

Rock Hill, South Carolina, 29732, United States

RECRUITING

Port Arthur

Port Arthur, Texas, 77642, United States

RECRUITING

Waco

Waco, Texas, 76712, United States

RECRUITING

Salt Lake City

Salt Lake City, Utah, 84112, United States

RECRUITING

United States

Norfolk, Virginia, 23507, United States

RECRUITING

Richmond

Richmond, Virginia, 23230, United States

RECRUITING

Yerevan

Yerevan, 0006, Armenia

RECRUITING

Yerevan

Yerevan, 0025, Armenia

RECRUITING

Yerevan

Yerevan, 0087, Armenia

RECRUITING

Camperdown

Camperdown, New South Wales, 2050, Australia

RECRUITING

Macquarie

Macquarie, New South Wales, 2109, Australia

RECRUITING

New Lambton

New Lambton, New South Wales, 2305, Australia

RECRUITING

Sydney

Sydney, New South Wales, 2010, Australia

RECRUITING

Wollongong

Wollongong, New South Wales, 2500, Australia

RECRUITING

Auchenflower

Auchenflower, Queensland, 4066, Australia

RECRUITING

Chermside

Chermside, Queensland, 4032, Australia

RECRUITING

Hobart

Hobart, Tasmania, 7000, Australia

RECRUITING

Malvern

Malvern, Victoria, 3145, Australia

RECRUITING

Camperdown

Camperdown, 2050, Australia

RECRUITING

New Lambton

New Lambton, 2305, Australia

RECRUITING

Austria

Vienna, 1100, Austria

RECRUITING

Brussel

Brussels, 1070, Belgium

RECRUITING

Genk

Genk, 3600, Belgium

COMPLETED

Pleven

Pleven, 5800, Bulgaria

RECRUITING

Plovdiv

Plovdiv, 4001, Bulgaria

RECRUITING

Sofia

Sofia, 1700, Bulgaria

RECRUITING

Sofia

Sofia, 1750, Bulgaria

RECRUITING

Tbilisi

Tbilisi, Tb, 0186, Georgia

RECRUITING

Tbilisi

Tbilisi, 0159, Georgia

RECRUITING

Tbilisi

Tbilisi, 0167, Georgia

RECRUITING

Tbilisi

Tbilisi, 0191, Georgia

RECRUITING

Mainz

Mainz, 55131, Germany

RECRUITING

Riga

Riga, LV10002, Latvia

RECRUITING

Chisinau

Chisinau, Moldova

RECRUITING

Christchurch

Christchurch, 8011, New Zealand

RECRUITING

Dunedin

Dunedin, 9016, New Zealand

RECRUITING

Białystok

Bialystok, 15-276, Poland

RECRUITING

Krakow

Krakow, 31-202, Poland

RECRUITING

Łodź

Lodz, 91-347, Poland

RECRUITING

Lublin

Lublin, 20-090, Poland

RECRUITING

Warsaw

Warsaw, 04-628, Poland

RECRUITING

Wrocław

Wroclaw, 50-556, Poland

RECRUITING

Almada

Almada, 2805-267, Portugal

RECRUITING

Lisboa

Lisbon, 1649-028, Portugal

RECRUITING

Porto

Porto, 4099-001, Portugal

RECRUITING

Bucuresti

Bucharest, 022328, Romania

RECRUITING

Craiova

Craiova, 200642, Romania

RECRUITING

Targu Mures

Târgu Mureş, 540136, Romania

RECRUITING

Nis, Belgrade

Belgrade, Nis, 18108, Serbia

RECRUITING

Belgrade

Belgrade, 11000, Serbia

RECRUITING

Serbia

Belgrade, 11040, Serbia

RECRUITING

Sremska Kamenica

Kamenitz, 21204, Serbia

RECRUITING

Kragujevac

Kragujevac, 34000, Serbia

RECRUITING

Barcelona

Barcelona, 08035, Spain

RECRUITING

Madrid

Madrid, 28034, Spain

RECRUITING

Madrid

Madrid, 28041, Spain

RECRUITING

Santiago de Compostela ( Coruña )

Santiago de Compostela, 15706, Spain

RECRUITING

Toledo

Toledo, 45007, Spain

RECRUITING

Valencia

Valencia, 46010, Spain

RECRUITING

Valencia

Valencia, 46015, Spain

RECRUITING

Ukraine

Kyiv, 01135, Ukraine

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Robert Rogers, MD

  Tectonic Therapeutic

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials

CONTACT

+1 339 337 4053; ClinicalTrials@tectonictx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2024
• First Posted: September 27, 2024
• Study Start: September 4, 2024
• Primary Completion (Estimated): October 9, 2026
• Study Completion (Estimated): November 20, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (31); LA (1); PL (6); SE (5); UA (1); NZ (2); AR (3); BE (2); PT (3); DE (1); ES (7); AU (1); MO (1); GE (4); BU (4); RO (3)