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Heart failure drug trial ends early – only 4 patients enrolled

NCT ID NCT06581159

Disease control Sponsor: 35Pharma Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This was a very early (Phase 1) study testing a drug called HS135 in obese patients who have both pulmonary hypertension and a type of heart failure called HFpEF. The trial was terminated after enrolling only 4 people, so we have no useful information on whether HS135 is safe or effective. The main goal was to check for side effects and measure how the drug moves through the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
HS135
What this could lead to
If it had worked, HS135 might have pointed toward a new treatment for obese patients with pulmonary hypertension and heart failure.
What could go wrong
This trial was terminated early with only 4 participants, so no conclusions can be drawn. It was a very early Phase 1 safety study, and the drug may not have been effective or safe.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

4 people

The number who actually took part.

Started

Jan 2025

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients are eligible to be included in the study only if they meet at least all the following criteria: 1. Male or female, \>18 years of age. 2. CardioMEMS™ Heart Failure System implanted during standard of care at least 90 days before Screening. 3. Established diagnosis of HFpEF with Left Ventricular Ejection Fraction (LVEF) at least 45% as measured by echocardiography during Screening. 4. New York Heart Association (NYHA) class II, III or IV heart failure symptoms. 5. BMI ≥ 30 kg/m2. 6. Ability to adhere to study visit schedule and understand and comply with all protocol requirements. Exclusion Criteria: Patients will be excluded from the study if they meet any of the following criteria: 1. Decompensated heart failure. 2. Admission for an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 30 days prior to Screening. 3. Implantation of cardiac resynchronization therapy (CRT) device within 90 days prior to Screening. 4. Planned cardiovascular revascularization or major cardiac surgery or planned implantation of CRT device. 5. History of heart transplant or on heart transplant list. 6. Uncontrolled systemic hypertension. 7. Patients who have an abnormality in echocardiography or electrocardiogram that in the opinion of the investigator increases the risk of participating in the study. 8. Patients who have full pneumonectomy or a severe chronic pulmonary disorder that in the opinion of the investigator increases the risk of participating in the study.

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Conditions

The condition(s) this trial relates to.

diastolic heart failure pulmonary hypertension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Heart failure with preserved ejection fraction Pulmonary hypertension

Contacts and locations

Locations

  • Site-104

    Phoenix, Arizona, 85016, United States

  • Site-105

    Kansas City, Missouri, 64111, United States

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