RecruitingPHASE2INTERVENTIONAL

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

This research study is looking at a new drug, APL-9796, for adults who have high blood pressure in the arteries of their lungs, a condition called pulmonary hypertension. This is an early-stage study (Phase 2), meaning we're still learning a lot about the treatment. The main goals are to check if APL-9796 is safe to use and if people can tolerate it well. We also want to see if it shows any signs of improving the condition for patients. The study involves giving the medication through injections under the skin. It will be conducted in two main groups: one for people with a specific type of pulmonary arterial hypertension, and potentially another for those whose pulmonary hypertension is linked to other lung diseases. Your participation could help us understand more about future treatment options.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Apollo Therapeutics Ltd

Enrolment target

Start

09 Apr 2025

Estimated completion

30 Sep 2027

Pulmonary Arterial Hypertension

What is this study about?

This study is investigating a new treatment called APL-9796 for a serious condition known as pulmonary hypertension (PH). PH is when the blood pressure in the arteries leading from your heart to your lungs becomes too high. This can make your heart work much harder and cause symptoms like breathlessness and tiredness. There are different types of PH, and this study is focusing on adults with specific forms of the condition.

The main purpose of this study is to learn more about APL-9796. Specifically, researchers want to find out if it's safe for people to take and if they can handle any side effects well. This type of study, called a Phase 2 trial, is still in the early stages, so we're looking for initial signs of whether the medication might be helpful. We'll also be checking how the body responds to APL-9796 and if it develops any reactions to it.

The study is planned in two parts. The first part will include adults with a type of PH called WHO Group 1 Pulmonary Arterial Hypertension (PAH). There's an optional second part for adults with PH linked to other lung conditions, specifically WHO Group 3 PH associated with Interstitial Lung Disease (PH-ILD). Studying these different groups will help us understand if APL-9796 could be a suitable treatment for various forms of pulmonary hypertension.

Key takeaways

Tests a new medication (APL-9796) for pulmonary hypertension.
Early-stage study focused on safety and initial effectiveness.
Involves under-the-skin injections and regular clinic visits.
For adults aged 18-80 with certain types of pulmonary hypertension.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you need to be an adult between 18 and 80 years old. You must have already been diagnosed with pulmonary hypertension, which would have been confirmed by a special test called a right heart catheterisation. Your doctor will also need to confirm that your pulmonary hypertension is currently categorised as WHO Functional Class II or III, which describes how much your condition impacts your daily activities. You also need to have a special sensor, called a CardioMEMS PA Sensor, already implanted.

There are some reasons why you might not be able to join. For example, if you've been in hospital recently for your pulmonary hypertension, or if you've had major surgery within the last three months and haven't fully recovered. Certain other medical conditions, like some heart diseases or kidney problems (severe kidney impairment), would also mean you couldn't take part. You also couldn't join if your pulmonary hypertension is due to certain causes like HIV or if you've had certain types of cancer within the last five years.

Finally, if you have conditions that would make it unsafe for you to have certain medical scans (like an MRI) or other tests required by the study, you wouldn't be able to participate. Your study doctor will carefully review all of these details with you to see if this study is a good fit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 80 years old?
Have you been diagnosed with pulmonary hypertension?
Do you have a CardioMEMS PA Sensor implanted?
Have you been free from hospital stays for PH or major surgery in the last 3 months?
Do you have any severe kidney problems or uncontrolled high blood pressure?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medication, APL-9796, through injections given under your skin. The study is designed to gradually increase the dose of the medication over time, to help researchers find the best and safest amount. You would have regular visits to the clinic for medical check-ups, blood tests, and other assessments to monitor your health and how you're responding to the treatment. These visits will help us understand if the medication is working and if you're experiencing any side effects.

The total duration of your participation in the study, including follow-up appointments after you stop taking the medication, would vary depending on the study part you are in and your individual response. The research team will explain the full schedule of visits and tests to you in detail before you make a decision. You will always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Potential risks and benefits

Participating in a clinical trial like this may offer potential benefits, such as access to a new experimental treatment (APL-9796) before it's widely available, and close medical monitoring of your condition. However, it's important to remember that this is an early-stage study, and we don't yet know if APL-9796 will be effective in treating pulmonary hypertension. There are also potential risks involved, including possible side effects from the medication, which will be carefully explained to you. As with any medical procedure, there could be discomfort or risks associated with blood tests or other assessments. You have the right to withdraw from the study at any time, for any reason, and this will not affect your future medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Hammersmith/Imperial Hospital
Verified postcode
London, United Kingdom· Recruiting
Royal United Hospital Bath
Verified postcode
Bath, United Kingdom· Recruiting
Royal Papworth Hospital
Verified postcode
Cambridge, United Kingdom· Recruiting
Golden Jubilee Hospital
Verified postcode
Clydebank, United Kingdom· Recruiting
Royal Brompton Hospital
Verified postcode
London, United Kingdom· Recruiting
Sheffield Teaching Hospitals
Verified postcode
Sheffield, United Kingdom· Recruiting

Common questions

What is pulmonary hypertension?

Pulmonary hypertension is high blood pressure in the arteries that carry blood from your heart to your lungs. It makes your heart work harder.

What is APL-9796?

APL-9796 is a new medication being tested in this study to see if it can help treat pulmonary hypertension. It's given by injection under the skin.

What does 'Phase 2' mean?

Phase 2 means it's an early stage of testing. Researchers are mainly looking at how safe the drug is and if it shows any promising signs of working.

Do I have to pay to be in the study?

No, you will not have to pay for the study medication or the specific tests related to the trial. Travel costs may be reimbursed, but you should check with the study team.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason. Your regular medical care will not be affected.

How to find out more

Sanjay Aggarwal, MD

AP13@apollotx.com 781-479-2267 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.