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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction

In brief

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).

Key facts

Study ID

NCT06616974

Run by

Tectonic Therapeutic

People needed

191

Starts

2024-09-04

Expected to finish

2027-01-05

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 83. Sex: any. Healthy volunteers: not accepted.

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.
• Has a history of cancer within 5 years of screening other than basal cell carcinoma, cervical carcinoma, or squamous cell carcinomas of the skin.
• Has a history of drug or alcohol abuse.
• Was recently dosed in any clinical research study.

Where it is running

• 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
• Augusta — Augusta, Georgia, United States
• McDonough — McDonough, Georgia, United States
• Boise — Boise, Idaho, 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
• Philadelphia — Philadelphia, Pennsylvania, United States
• Pittsburgh — Pittsburgh, Pennsylvania, United States
• York — York, Pennsylvania, 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
• Phoenix — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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