126 Participants NeededMy employer runs this trial

HS235 for Pulmonary Hypertension and Heart Failure

Recruiting at 2 trial locations
RJ
Overseen ByRoxanne Julien, M.Sc
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: 35Pharma Inc

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.12345

Why 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?

MC

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

I have a device monitoring my lung blood pressure, showing high readings for the last 2 weeks.
I can follow the study's schedule and understand all its requirements.
My BMI is between 30 and 50, and I weigh 140 kg or less.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple doses of HS235 or placebo via subcutaneous injection

Up to 85 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

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

Group I: Investigational ProductExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

35Pharma Inc

Lead Sponsor

Trials
3
Recruited
120+

35Pharma Inc., a GSK company

Lead Sponsor

Citations

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