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NCT05612035

Frespaciguat (MK-5475) INSIGNIA-PH-COPD: A Study of the Efficacy and Safety of Frespaciguat (an Inhaled sGC Stimulator) in Adults With PH-COPD

StatusActive, Not Recruiting
PhasePhase 2
Primary completion
Track this trial

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Record History

The 50 most recent of 57 versions: 46 with changes below, 4 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 28 words
    • Study completion moved earlier from Oct 8, 2029 to May 1, 2027
    • Secondary endpoints: details revised at 4 of 7 entries
    • Site details revised at 5 of 85 sites
  2. Enrollment target: estimated 120 to confirmed 129
    • Primary completion date changed from estimate of Apr 7, 2026 to Apr 9, 2026
    • Study completion date: Oct 7, 2029 to Oct 8, 2029
    v56
  3. Study sites: 84 to 85v53
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 84 of 84 sites
    v51
  5. Site details revised at 10 of 84 sitesv50
Show 41 earlier versionsHide 41 earlier versions
  1. Site details revised at 7 of 84 sitesv49
  2. Site contacts updated at 6 of 84 sitesv48
  3. Site contacts updated at 2 of 84 sitesv47
  4. Site contacts updated at 1 of 84 sitesv46
  5. Site details revised at 1 of 84 sitesv45
  6. Site contacts updated at 2 of 84 sitesv44
  7. Interventions: Placebo (Drug), frespaciguat (Drug) to Frespaciguat (Drug), Placebo (Drug)
    • Study sites revised (84)
    • Study title expanded, about 1 word
    v43
  8. Study sites: 83 to 84
    • Interventions: MK-5475 (Drug), Placebo (Drug) to Placebo (Drug), frespaciguat (Drug)
    • Study title revised
    v42
  9. Study sites: 82 to 83v41
  10. Study sites: 81 to 82v40
  11. Study sites revised (81)v39
  12. Site details revised at 1 of 81 sitesv38
  13. Site details revised at 54 of 81 sitesv37
  14. Study sites: 80 to 81v36
  15. Study sites: 79 to 80v35
  16. Study sites: 75 to 79
    • Study completion date: Mar 23, 2028 to Oct 7, 2029
    • Secondary endpoints: details revised at 2 of 7 entries
    v34
  17. Site details revised at 1 of 75 sitesv32
  18. Study sites: 74 to 75v31
  19. Study sites: 72 to 74v30
  20. Study sites: 69 to 72v29
  21. Study sites: 67 to 69v28
  22. Study sites: 66 to 67v27
  23. Study sites: 64 to 66v26
  24. Study sites: 63 to 64v25
  25. Study sites: 61 to 63v24
  26. Study sites: 60 to 61v23
  27. Study sites: 56 to 60v22
  28. Study sites: 55 to 56v21
  29. Primary completion date: Mar 14, 2025 to Apr 7, 2026
    • Study sites: 53 to 55
    • Study completion date: Sep 15, 2026 to Mar 23, 2028
    v20
  30. Study sites: 51 to 53v19
  31. Eligibility criteria expanded, about 36 words
    • Study sites: 49 to 51
    v18
  32. Study sites: 48 to 49v17
  33. Eligibility criteria expanded, about 5 wordsv16
  34. Study sites: 46 to 48v15
  35. Site details revised at 1 of 46 sitesv14
  36. Study sites: 42 to 46v13
  37. Study sites: 39 to 42v12
  38. Site details revised at 1 of 39 sitesv11
  39. Study sites: 38 to 39v10
  40. Study sites: 35 to 38v9
  41. Study sites: 25 to 35v8
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Mean Change From Baseline in 6-minute Walk Distance (6MWD) at Week 24
Timeframe: Baseline and Week 24

Secondary (7)

Mean Change From Baseline in 6MWD at Week 12
Mean Change From Baseline in N-Terminal Pro B-Type Natriuretic Peptide (NT-proBNP) at Week 12
Mean Change From Baseline in NT-ProBNP at Week 24
Percentage of Participants Whose World Health Organization-Functional Class (WHO-FC) Does not Worsen Relative to Baseline at Week 12
Percentage of Participants Whose WHO-FC Does not Worsen Relative to Baseline at Week 24
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Percentage of Participants With One or More Adverse Events (AEs)
Percentage of Participants who Discontinued Study Treatment due to an AE

Arms and interventions

FrespaciguatExperimental

Participants with PH-COPD will receive 380 µg of frespaciguat as an oral inhalation once daily for 24 weeks (base period) and thereafter for up to 42 months (optional extension period).

PlaceboPlacebo comparator

Participants with PH-COPD will receive matching placebo as an oral inhalation once daily for 24 weeks (base period) and then 380 µg of frespaciguat as an oral inhalation once daily for up to 42 months (optional extension period).

Drugs: Frespaciguat, Placebo

Sites

85 sites in 19 countries

United States 18, Argentina 5, Australia 5, France 5, Germany 5, Spain 5, Turkey (Türkiye) 5, Colombia 4, Guatemala 4, Mexico 4, South Africa 4, South Korea 4, Italy 3, Peru 3, Switzerland 3, Austria 2, Belgium 2, Israel 2, United Kingdom 2