HS235 for Pulmonary Hypertension and Heart Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called HS235, a potential drug for pulmonary hypertension (high blood pressure in the lungs) and heart failure. Researchers focus on individuals who are overweight or obese and have a type of heart failure where the heart pumps normally, but the heart muscle is stiff. Participants will receive either the HS235 treatment or a placebo (a harmless, inactive substance) to evaluate the treatment's effectiveness. Ideal candidates for this trial are those diagnosed with heart failure, experiencing symptoms like shortness of breath or fatigue, and who can easily walk at least 100 meters. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to be among the first to try a potentially groundbreaking treatment.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that HS235 is likely to be safe for humans?
Research has shown that HS235, a new drug, is being tested for treating pulmonary hypertension, a type of high blood pressure affecting the lungs. Although detailed information about its safety in humans is limited, the initiation of trials indicates that earlier lab and animal tests did not reveal major safety issues, a necessary step before human testing.
HS235 is also under investigation for heart and lung conditions, suggesting researchers believe it might be safe for these uses. So far, past studies have not shown serious side effects in humans. However, as this is an early-stage trial, the complete safety profile in humans is still being determined.
In summary, while detailed human safety data is not yet available, the progression to human trials and its study for serious conditions suggest researchers have some confidence in its safety. As always, joining a clinical trial involves risks, and potential participants should discuss these with their healthcare provider.12345Why do researchers think this study treatment might be promising for pulmonary hypertension and heart failure?
Unlike the standard treatments for pulmonary hypertension and heart failure, which often include oral medications or intravenous therapies, HS235 introduces a new approach with its subcutaneous injection method. This delivery method allows for potentially better absorption and convenience compared to traditional options. Researchers are particularly excited because HS235 may work through a new mechanism of action, offering hope for those who haven't responded well to existing treatments. Additionally, the unique formulation of HS235 could lead to improved outcomes in managing these challenging conditions.
What evidence suggests that HS235 might be an effective treatment for pulmonary hypertension and heart failure?
Research has shown that HS235 is under study for its potential to help with pulmonary hypertension, which is high blood pressure in the lungs, and heart failure with preserved ejection fraction. Early results from similar treatments have been promising for improving these conditions. Although limited information exists on HS235 in humans, its mechanism appears promising for these health issues. Participants in this trial will receive either HS235 or a placebo. The treatment aims to improve heart and lung function, which are key problems in these conditions.678910
Who Is on the Research Team?
Monique Champagne, M.Sc
Principal Investigator
35Pharma Inc
Are You a Good Fit for This Trial?
This trial is for adults (18+) who are obese (BMI 30–50), have pulmonary hypertension and heart failure with preserved ejection fraction, stable on diuretics, can walk at least 100 meters in six minutes, and use a specific heart pressure monitor. Participants must be able to follow study instructions.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive multiple doses of HS235 or placebo via subcutaneous injection
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HS235
Trial Overview
The study compares the new drug HS235 to a placebo in people with obesity-related pulmonary hypertension and HFpEF. Participants are randomly assigned to receive either HS235 or an inactive treatment to see if HS235 improves their condition.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
HS235 Subcutaneous Injection
Subcutaneous Injection
Find a Clinic Near You
Who Is Running the Clinical Trial?
35Pharma Inc
Lead Sponsor
35Pharma Inc., a GSK company
Lead Sponsor
Citations
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Pulmonary arterial hypertension (PAH) is a disorder characterized by a progressive, proliferative vasculopathy primarily affecting the pulmonary arterioles [1]
JACC | ACC.26Abstracts of Original Contribution
... PULMONARY HYPERTENSION AND RIGHT VENTRICULAR FAILURE: A RETROSPECTIVE COHORT STUDY ... PULMONARY ARTERIAL HYPERTENSION DATA. Shaleen Thakur, Megan Griffiths, ...
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longevity.technology
longevity.technology/news/gsk-acquires-35pharma-in-950m-deal-advancing-ph-drug/GSK acquires 35Pharma in $950m deal, advancing PH drug
While it enters the pipeline as a pulmonary drug, its potential reach extends beyond the lungs. If HS235 can deliver on both safety and ...
10.
statnews.com
statnews.com/pharmalot/2026/02/25/trump-pharma-novo-obesity-novartis-medicare-clindamycin/We're reading about Trump drug-price claims, Novo ...
The centerpiece of the deal is an experimental drug called HS235 that is set to start trials in pulmonary arterial hypertension, a form of high ...
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