Study of HS235 in Obese Patients With Pulmonary Hypertension and Heart Failure With Preserved Ejection Fraction (HFpEF)

NCT07123779 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: HS235-003
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Study of HS235 in Obese Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction Utilizing Ambulatory Pulmonary Artery Pressure Monitoring

Conditions

Pulmonary Hypertension; Heart Failure With Preserved Ejection Fraction

Outcome Measures

Primary Outcomes (1)

• Incidence and Number of Adverse Events (AEs)

  An AE is any untoward medical occurrence in a patient or clinical trial patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The incidence and number of patients who experience an AE will be reported.

  Up to 24 weeks

Study Arms (2)

Investigational Product

EXPERIMENTAL

HS235 Subcutaneous Injection

Biological: HS235

Placebo

PLACEBO COMPARATOR

Subcutaneous Injection

Other: Placebo

Interventions

HS235 BIOLOGICAL

Subcutaneous Injection

Investigational Product

Placebo OTHER

Subcutaneous Injection

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients are eligible to be included in the study only if they meet at least all the following criteria:
• Male or female, ≥ 18 years of age.
• Ambulatory pulmonary artery pressure (PAP) monitoring (e.g. CardioMEMS™ HF System or Cordella™ HF System) implanted in the course of standard of care at least 90 days before Screening with mean pulmonary artery pressure (mPAP) ≥ 25 mmHg and diastolic pulmonary artery pressure(dPAP) ≥ 15 mmHg as averaged over the last 2 weeks prior to Randomization.
• Established diagnosis of HFpEF with left ventricular ejection fraction (LVEF) ≥ 45 % as measured by echocardiography during Screening.
• New York Heart Association (NYHA) class II or III heart failure symptoms.
• Stable diuretic regimen during the screening period.
• Kansas City Cardiomyopathy Questionnaire-Clinical Summary Score (KCCQ-CSS) \< 90 at screening.
• minute walking distance (6MWD) ≥ 100 m at screening.
• Body mass index ≥ 30 to ≤ 50 kg/m2 and Body weight ≤140 kg.
• Ability to adhere to study visit schedule and understand and comply with all protocol requirements.

You may not qualify if:

• Hospitalization for any worsening medical condition or major surgery within 4 weeks prior to screening.
• Occurrence of an acute coronary syndrome, percutaneous coronary intervention, or cardiac surgery within 90 days prior to Screening.
• Implantation of a cardiac resynchronization therapy (CRT) device within 90 days before screening.
• Planned cardiovascular revascularization or planned implantation of CRT device.
• History of heart transplant or on heart transplant list.
• History of serious or life-threatening cardiac arrhythmia within 90 days prior to screening.
• Systemic hypotension or uncontrolled systemic hypertension.
• History of Pericardial constriction or hypertrophic cardiomyopathy.
• History of significant valvular stenosis or regurgitation.
• Patients with a pneumonectomy or more than moderate Chronic Obstructive Pulmonary Disease (COPD) or mild interstitial lung disease (ILD) or mild obstructive sleep apnea (OSA).

Sponsors & Collaborators

• 35Pharma Inc: lead

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Monique Champagne, M.Sc

  35Pharma Inc

  STUDY DIRECTOR

Central Study Contacts

Roxanne Julien, M.Sc

CONTACT

438-439-9168; clinicaltrials@35pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-Blinded, Placebo controlled
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 14, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: August 14, 2025

Record last verified: 2025-07