HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction

NCT07123779 | Recruiting Phase 1 FDA Drug

• 1 other identifier: HS235-003
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

Brief Summary

Study of HS235 in Overweight and Obese Participants with Combined Pre and Post-Capillary Pulmonary Hypertension due to Heart Failure with Preserved Ejection Fraction

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 participant or clinical trial participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. The incidence and number of participants who experience an AE will be reported.

  Up to 85 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:

• Participants 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.
• \[Sub-population A only - using a remote PAP sensor\]- Ambulatory 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.
• Hemodynamic evidence of PH with:
• mPAP ≥ 25 mm Hg, as measured by the ambulatory PAP monitoring system in supine position by the averaged 7-day values (weekly average) 2 weeks and 1 week before Randomization AND,
• dPAP ≥ 15 mm Hg, as measured by the ambulatory PAP monitoring system in supine position by the averaged 7-day values (weekly average) 2 weeks and 1 week before Randomization.
• Hemodynamic evidence of pre-capillary PH based on presence of PVR ≥ 240 dyn\*sec/cm5 or ≥ 3 WU obtained on most recent RHC obtained prior to screening.
• \[Sub-population B only - without a remote PAP sensor\]
• Hemodynamic evidence of Cpc-PH based on the presence of all the following RHC parameters obtained during the Screening period, prior to randomization:
• PVR ≥ 240 dyn\*sec/cm5 or ≥ 3 WU, and
• mPAP \> 20 mmHg, and
• PAWP \> 15 mmHg but \< 30 mmHg, and
• dPAP ≥ 15 mmHg.
• Established diagnosis of HFpEF with left ventricular ejection fraction (LVEF) ≥ 45 % as measured by echocardiography during Screening and and no documented LVEF \< 45% during the 2 years preceding Screening..
• New York Heart Association (NYHA) class II or III heart failure symptoms.

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.
• Participants with a pneumonectomy or more than moderate Chronic Obstructive Pulmonary Disease (COPD) or mild interstitial lung disease (ILD) or untreated mild obstructive sleep apnea (OSA).

Sponsors & Collaborators

• 35Pharma Inc: lead

Study Sites (2)

Investigational Site-105

Kansas City, Missouri, 64111, United States

RECRUITING

Investigational Site-101

Greenville, South Carolina, 29605, United States

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

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

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: September 29, 2026

Record last verified: 2026-08

Locations

US (2)