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Not yet recruitingNCT07761572EPIMODEUpdated Aug 12, 2026

CS1 Added to Standard of Care Therapy for Pulmonary Arterial Hypertension

A Phase 2 interventional study of CS1 and Placebo in Pulmonary Arterial Hypertension, sponsored by Cereno Scientific AB. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-12.

Sponsored by Cereno Scientific AB · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This Phase 2 study (EPIMODE) will evaluate the efficacy and safety of CS1 compared with placebo when added to standard-of-care therapy in participants with pulmonary arterial hypertension.

Participants completing Treatment Period 1 (Week 36) will be re-randomized to continue or switch study treatment for Treatment Period 2 through Week 52.

02

Conditions studied

  • Pulmonary Arterial Hypertension

Keywords

  • CS1
  • Pulmonary Arterial Hypertension
  • PAH
  • Sodium Valproate
  • Valproic Acid
  • Pulmonary Vascular Resistance
  • 6-Minute Walk Distance
03

In context

Pulmonary Arterial Hypertension

699 studies on the registry are indexed under Pulmonary Arterial Hypertension; 140 are open to participants now.

This study's planned enrollment of 126 is above the median of 40 across 477 interventional studies indexed under Pulmonary Arterial Hypertension.

Browse Pulmonary Arterial Hypertension studies →

Lead sponsor

Cereno Scientific AB is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 18 to 80 years
  • WHO Group 1 pulmonary arterial hypertension
  • WHO Functional Class II or III
  • REVEAL Lite 2 score ≥6
  • Receiving stable standard-of-care PAH therapy for at least 90 days prior to screening
  • Hemodynamic confirmation of PAH by right heart catheterization
  • 6-minute walk distance ≥150 m and \<550 m

Exclusion criteria

Exclusion Criteria:

  • Pulmonary hypertension WHO Group 2, 3, 4, or 5
  • Significant left-sided heart disease
  • Recent major cardiovascular or cerebrovascular event
  • Prior heart or heart-lung transplantation or active lung transplant listing
  • Significant renal or hepatic dysfunction
  • Current use of prohibited medications that cannot be discontinued
  • Pregnant or breastfeeding
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
126 participants (estimated)

Study arms

  • Experimental
    CS1 320 mg

    2 capsules of CS1 160 mg and 2 capsules of placebo

    Drug: CS1 · Drug: Placebo

  • Experimental
    CS1 640 mg

    4 capsules of CS1 160 mg

    Drug: CS1

  • Placebo comparator
    Placebo

    4 capsules of placebo

    Drug: Placebo

Interventions

  • DrugCS1

    160 mg delayed release capsules taken orally once daily in the evening

  • DrugPlacebo

    Matching placebo capsules taken orally once daily in the evening

06

What researchers measure

Primary outcomes

  1. Change from baseline in pulmonary vascular resistance (PVR)

    Pulmonary vascular resistance calculated from right heart catheterization measurements using the Thermodilution or Fick method for determination of cardiac output.

    Time frame: Baseline to Week 36

Secondary outcomes

  1. Change from baseline in 6-minute walk distance (6MWD)

    Time frame: Baseline to Week 36

  2. Change from baseline in Registry to Evaluate Early and Long-term Pulmonary Arterial Hypertension Disease Management (REVEAL) Lite 2 score

    Time frame: Baseline to Week 36

  3. Change from baseline in REVEAL Risk Score (RRS) 2.0

    Time frame: Baseline to Week 36

  4. Change from baseline in tricuspid annular plane systolic excursion (TAPSE)

    Time frame: Baseline to Week 36

  5. Change from baseline in right ventricular (RV) strain

    Time frame: Baseline to Week 36

  6. Change from baseline in World Health Organization (WHO) Functional Class

    WHO Functional Class ranges from Class I to Class IV, with lower class indicating better functional status.

    Time frame: Baseline to Week 36

  7. Percentage of participants with improvement in WHO Functional Class

    WHO Functional Class ranges from Class I to Class IV, with lower class indicating better functional status.

    Time frame: Week 36

  8. Change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) or B-type natriuretic peptide (BNP)

    Time frame: Baseline to Week 36

  9. Change from baseline in mean pulmonary arterial pressure (mPAP)

    Time frame: Baseline to Week 36

  10. Change from baseline in cardiac output (CO)

    Time frame: Baseline to Week 36

  11. Percentage of participants with clinical worsening of pulmonary arterial hypertension (PAH)

    Clinical worsening as defined in the study protocol.

    Time frame: Week 36

  12. Time to first clinical worsening event

    Clinical worsening as defined in the study protocol.

    Time frame: Baseline through Week 36

  13. Change from baseline in PAH-SYMPACT (Pulmonary Arterial Hypertension Symptoms and Impact Questionnaire) domain scores

    Domain scores assess symptoms and impacts of PAH; higher scores indicate greater symptom burden and disease impact.

    Time frame: Baseline to Week 36

  14. Change in 6MWD from Week 36

    Time frame: Week 36 to Week 52

  15. Change in TAPSE from Week 36

    Time frame: Week 36 to Week 52

  16. Change in RV strain from Week 36

    Time frame: Week 36 to Week 52

  17. Change in NT-proBNP or BNP from Week 36

    Time frame: Week 36 to Week 52

  18. Change in WHO Functional Class from Week 36

    WHO Functional Class ranges from Class I to Class IV, with lower class indicating better functional status.

    Time frame: Week 36 to Week 52

  19. Change in REVEAL Lite 2 score from Week 36

    Time frame: Week 36 to Week 52

  20. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Up to Week 56

  21. Incidence of serious adverse events (SAEs)

    Time frame: Up to Week 56

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Feb 2029, 28 months later.

Of 28 industry-sponsored phase 2 interventional studies under Pulmonary Arterial Hypertension, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 48. This study's planned 28 months is close to that.

Counting every sponsor, half of 51 studies reached it within 44 months; a quarter within 26 and three quarters within 65.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2026
First posted
Aug 12, 2026
StartEst.
Sep 15, 2026
Primary completionEst.
Feb 2, 2029
CompletionEst.
Apr 30, 2029
Last update
Aug 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07761572
Lead sponsor
Cereno Scientific AB
Responsible party
Sponsor
First posted
Aug 12, 2026
Start date
Sep 15, 2026 (estimated)
Primary completion
Feb 2, 2029 (estimated)
Completion
Apr 30, 2029 (estimated)
Last update
Aug 12, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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