HS235 / Pulmonary Hypertension / Heart Failure With Preserved Ejection Fraction · Phase 1/2 Trial

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

ClinicalTrials.gov · August 17, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a registered Phase 1/2 trial of HS235, a biologic agent, in obese patients with concurrent pulmonary hypertension and heart failure with preserved ejection fraction. The trial is currently recruiting and has not yet reported results; the primary endpoint is safety (adverse events) over 24 weeks. No efficacy data, mechanistic insights, or comparative outcomes are available from this registry record.

What was studied

Phase 1/2, Interventional, Randomized, Sequential, Quadruple masking, Treatment purpose. Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction; age from 18 Years. Intervention: Investigational Product. Compared with: Placebo — Placebo Comparator. n = 126. 1 site: United States.

Key findings

Safety

Primary endpoint is safety; efficacy signals, if any, are not yet reported.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a Phase 1/2 trial registration with no posted results; it is early-stage work in a novel biologic for a rare comorbid phenotype.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Incidence and Number of Adverse Events (AEs) (assessed at Up to 24 weeks)

DesignPhase 1/2, Interventional, Randomized, Sequential, Quadruple masking, Treatment purpose

PopulationPulmonary Hypertension, Heart Failure With Preserved Ejection Fraction; age from 18 Years

Sample size126

InterventionInvestigational Product

ComparatorPlacebo — Placebo Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Estimated enrollment126

PhasePhase 1/2

Primary outcome measureIncidence and Number of Adverse Events, up to 24 weeks

Study typeInterventional

Caveats

This is a registry record only; no results have been posted and no outcome data are available.
Primary endpoint is safety; efficacy signals, if any, are not yet reported.
Study is in early phase (Phase 1/2); duration of follow-up (24 weeks) is limited for chronic disease outcomes.
Recruitment status is ongoing; enrollment and results are not finalized.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Randomized interventional trial with placebo comparator; phase and size appropriate for early signal

Directness

moderate

Clinical population (obese PH + HFpEF) relevant; primary endpoint (safety) is direct measure

Consistency

insufficient

No results posted; no comparison to prior or concurrent evidence possible

Risk of bias

moderate

Placebo-controlled design mitigates bias; early phase limits long-term outcome assessment

Sample adequacy

moderate

126 participants estimated; appropriate for Phase 1/2 safety and signal detection

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07123779). This is a study registration, not published results. Lead sponsor: 35Pharma Inc. Recruitment status: RECRUITING. Phase: PHASE1, PHASE2. Study type: INTERVENTIONAL. Enrollment: 126 participants (ESTIMATED). Conditions: Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction. Interventions: BIOLOGICAL: HS235; OTHER: Placebo. Primary outcome measures: Incidence and Number of Adverse Events (AEs) , Up to 24 weeks. Brief summary: Study of HS235 in Obese Participants with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

NCT07123779HS23535PharmaPulmonary HypertensionHeart Failure With Preserved Ejection Fraction