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

Conditions

• Heart Failure With Preserved Ejection Fraction
• Pulmonary Hypertension

Eligibility Criteria

Sex

ALL

Age

18 Years - 83 Years

Healthy Volunteers

Not accepted

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 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.
• Placebo — DRUG
  The participants will receive a subcutaneous injection of placebo every 2 weeks for 24 weeks.

Study Details

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 Dates

Start date

Sep 4, 2024

Status verified

Mar 2026

Primary completion

Oct 9, 2026

Completion

Nov 20, 2026

Study Design

Enrollment

180 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: TX000045 Dose A
  Participants will receive a single dose of TX000045 Dose A subcutaneously every 2 weeks for 24 weeks from Day 1 to Day 155.
• Experimental: TX000045 Dose B
  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.
• Placebo Comparator: Placebo
  Participants will receive a single placebo dose SC for 24 weeks from Day 1 to Day 155

Primary Outcome Measure

Mean change from baseline in Pulmonary Vascular Resistance (PVR) in participants with a combined pre- and post-capillary pulmonary hypertension (CpcPH). [ Time Frame: Baseline up to Week 24 post first dose ]

Central Contacts

• Clinical Trials
  +1 339 337 4053
  [email protected]

Locations (31)

Find similar trials in Phoenix, AZ

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