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Virus Therapy

HS135 for Heart Failure and Pulmonary Hypertension

Phase 1
Waitlist Available
Research Sponsored by 35Pharma Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 weeks

Summary

This trial is testing a new drug, HS135, to see if it can help obese patients with both pulmonary hypertension and heart failure with preserved ejection fraction.

Who is the study for?
This trial is for adults over 18 with obesity (BMI ≥ 30 kg/m2), diagnosed heart failure where the heart pumps normally (LVEF at least 45%), and symptoms that affect daily life to varying degrees. They must have a CardioMEMS™ device implanted for monitoring heart failure, be able to follow the study plan, and understand protocol requirements.
What is being tested?
The trial is testing HS135 against a placebo in obese patients who have both pulmonary hypertension—a type of high blood pressure affecting lungs' arteries—and heart failure with normal pumping function. The goal is to see if HS135 can improve their condition.
What are the potential side effects?
Potential side effects are not specified here, but generally, clinical trials may monitor for any unexpected reactions such as headaches, nausea, or more serious complications related to the drug's action on the body.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My heart pumps well, with an ejection fraction of 45% or higher.
Select...
I experience moderate to severe symptoms of heart failure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Alanine aminotransferase (ALT)
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Albumin
Change from Baseline in Clinical Laboratory Parameters (Biochemistry): Alkaline phosphatase (ALP)
+28 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Investigational ProductExperimental Treatment1 Intervention
HS135 Subcutaneous Injection
Group II: PlaceboPlacebo Group1 Intervention
Subcutaneous Injection

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Who is running the clinical trial?

35Pharma IncLead Sponsor
1 Previous Clinical Trials
24 Total Patients Enrolled
Monique Champagne, M.ScStudy Director35Pharma Inc
~20 spots leftby Apr 2026
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