Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT04775706 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 14 to 15v23
  2. Study sites: 13 to 14v22
  3. Study sites revised (13)v21
  4. Study sites: 14 to 13v20
  5. Study sites: 15 to 14v19
Show 17 earlier versionsHide 17 earlier versions
  1. Site details revised at 3 of 15 sites
    • Study title expanded, about 3 words
    v18
  2. Site details revised at 1 of 15 sitesv17
  3. Site details revised at 2 of 15 sitesv16
  4. Study sites revised (15)v15
  5. Re-verified, no change to tracked fieldsv14
  6. Primary completion date: Dec 2025 to Dec 2027
    • Study completion date: Dec 2025 to May 2028
    • Study sites revised (15)
    v13
  7. Study sites: 12 to 15
    • Eligibility criteria shortened, about 16 words
    • Study description expanded, about 1 word
    v12
  8. Study sites: 13 to 12v11
  9. Re-verified, no change to tracked fieldsv10
  10. Enrollment target: 7 to 18
    • Primary and study completion dates: Dec 2023 to Dec 2025
    • Study sites: 11 to 13
    v9
  11. Study sites: 9 to 11v8
  12. Study sites: 7 to 9v7
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2022 to Mar 3, 2022
    • Site details revised at 7 of 7 sites
    v6
  14. Start date: Oct 2021 to Jan 2022
    • Study sites: 8 to 7
    v5
  15. Study sites: 9 to 8v4
  16. Start date: Jun 2021 to Oct 2021
    • Study sites: 0 to 9
    v3
  17. Study title shortened, about 3 wordsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912(sonefpeglutide) in adult subjects with SBS-associated intestinal failure (SBS-IF).
Trial Details
NCT Number NCT04775706
Lead Sponsor Hanmi Pharmaceutical Company Limited
Conditions
(from sponsor)		 Short Bowel Syndrome
Related terms Short Bowel Syndrome
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov