A Trial of "APL-9796'' in Adults With Pulmonary Hypertension

Launched by APOLLO THERAPEUTICS LTD · Feb 20, 2025

Keywords

ClinConnect Summary

The APL-9796 trial is a research study looking at a new treatment for adults with pulmonary arterial hypertension (PAH), a condition that affects the blood vessels in the lungs and can make it hard to breathe. This study will test how safe and effective APL-9796 is when given as multiple injections under the skin. It will involve up to 36 adults with PAH and an optional group of 12 adults who have pulmonary hypertension related to lung diseases.

To join the trial, participants need to be between 18 and 80 years old, have been diagnosed with pulmonary hypertension through a specific test called right heart catheterization, and have a CardioMEMS PA Sensor implanted. They should also be in certain functional classes that indicate how their condition affects their daily activities. Participants will receive the treatment and will be monitored for safety and effectiveness. It's important to note that individuals with certain serious health issues or recent hospitalizations may not be eligible for this study. This trial is actively recruiting, and it offers a chance to help researchers understand more about treating PAH.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participant must be 18 to 80 years of age inclusive
• • 2. Participants who are diagnosed with pulmonary hypertension via right heart catheterisation (RHC), documented at any time prior to Screening.
• • 3. WHO Functional Class II or III
• • 4. Participant has the CardioMEMS PA Sensor implanted.
• Exclusion Criteria:
• • 1. Hospital admission related to PH within 3 months prior to Screening.
• • 2. Major surgical procedure within 3 months prior to Screening, unless participant is assessed as completely recovered by the Investigator
• • 3. Diagnosis of PH due to human immunodeficiency virus, portal hypertension, schistosomiasis, or uncorrected congenital heart disease
• • 4. History of left-sided heart disease and/or clinically significant cardiac disease
• • 5. History of uncontrolled systemic hypertension
• • 6. eGFR ≤30 ml/min/1.73m2
• • 7. Life expectancy of \< 12 months, as assessed by the Investigator
• • 8. Diagnosed with a malignancy within 5 years of enrolment
• • 9. Contraindications to protocol-required imaging (MRI), diagnostic, or sampling methods