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

Last updated: January 28, 2026
Sponsor: Tectonic Therapeutic
Overall Status: Active - Recruiting

Phase

2

Condition

Stress

Heart Disease

Vascular Diseases

Treatment

TX000045- Dose A

Placebo

TX000045- Dose B

Clinical Study ID

NCT06616974
TX000045-003
  • Ages 18-83
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

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

  2. Has a diagnosis of PH-HFpEF based on baseline echocardiogram and right heartcatheterization (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 doseprior to screening.

  6. Is able to understand and provide documented consent for participation.

Exclusion

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-specifictherapies, or a relaxin receptor agonist.

  4. Initiated a new exercise program for cardiopulmonary rehabilitation or plans toinitiate 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 suchas significant lung disease, cardiovascular comorbitiies, liver disease, infectiousdisease, or malignancy.

  8. Has any of the following clinical laboratory values during screening:

  9. Serum alanine aminotransferase or aspartate aminotransferase levels > 3 x theupper limit of normal (ULN) or total bilirubin > 3 x ULN;

  10. eGFR <30 mL/min/1.73 m2;

  11. HbA1c (glycosylated hemoglobin) >9%;

  12. Platelet count <50,000/millimeter cube;

  13. Hemoglobin <10.0g/dL;

  14. History of hypersensitivity or reactions to drugs with a similar chemical structureor class to TX000045.

  15. Is pregnant or breastfeeding.

  16. Has a history of cancer within 5 years of screening other than basal cell carcinoma,cervical carcinoma, or squamous cell carcinomas of the skin.

  17. Has a history of drug or alcohol abuse.

  18. Was recently dosed in any clinical research study.

Study Design

Total Participants: 180
Treatment Group(s): 3
Primary Treatment: TX000045- Dose A
Phase: 2
Study Start date:
September 04, 2024
Estimated Completion Date:
November 20, 2026

Study Description

This study will enroll approximately 180 participants and eligible patients will be randomized to one of 3 treatment arms:

  • Arm 1: Treatment Group 1: Placebo delivered subcutaneously (SC) every 2 weeks (Q2W) for 24 weeks

  • Arm 2: Treatment Group 2: TX000045 SC at Dose A Q2W for 24 weeks

  • Arm 3: Treatment Group 3: TX000045 SC at Dose B Q2W alternating with Placebo Q2W for 24 weeks

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  • Yerevan

    Yerevan, 0087
    Armenia

    Site Not Available

  • Yerevan

    Yerevan 616052, 0087
    Armenia

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  • Westmead Hospital

    Macquarie, New South Wales 2109
    Australia

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    Sydney, New South Wales 2010
    Australia

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    Wollongong, New South Wales 2500
    Australia

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    Macquarie, New South Wales 2155400 2109
    Australia

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    Sydney 2147714, New South Wales 2155400 2010
    Australia

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    Wollongong 2171507, New South Wales 2155400 2500
    Australia

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    Australia

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    Chermside, Queensland 4032
    Australia

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    Auchenflower 6943571, Queensland 2152274 4066
    Australia

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    Chermside 6943582, Queensland 2152274 4032
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    Hobart, Tasmania 7000
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    Hobart 2163355, Tasmania 2147291 7000
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    Malvern, Victoria 3144
    Australia

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    Camperdown 2172563, 2050
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    New Lambton 2205629, 2305
    Australia

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    Richmond 4781708, Virginia 6254928 23230
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