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NCT04775706 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
A Phase 2 study of Short Bowel Syndrome, sponsored by Hanmi Pharmaceutical Company Limited.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 18
- Enrollment target
- 13
- Study locations
NCT04775706: Recruiting Phase 2 study of Short Bowel Syndrome, sponsored by Hanmi Pharmaceutical Company Limited.
NCT04775706 is a Phase 2 study of Short Bowel Syndrome that is actively recruiting participants, run by Hanmi Pharmaceutical Company Limited. The registered enrollment target is 18 participants, below the 184-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (90% lower). The trial reports 13 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04775706, a Phase 2 study of Short Bowel Syndrome, is actively recruiting participants, sponsored by Hanmi Pharmaceutical Company Limited.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 18 participants
- Enrollment target
- 13
- Study locations
Study Summary
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).
Primary Outcome
after multiple subcutaneous (SC) doses
Conditions Studied
Interventions
- DRUG Placebo
- DRUG HM15912 Active
Study Locations (13)
Other
- Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure - Copenhagen
- Centre Hospitalier Universitaire de Bordeaux - Bordeaux
- Les Hospices Civils de Lyon - Lyon
- Centre Hospitalier Universitaire de Nice - Nice
- Samsung Medical Center - Seoul
- Central Middlesex Hospital - London
Massachusetts
- Brigham & Women's Hospital - Boston
Ohio
- The Cleveland Clinic Foundation - Cleveland
Vlaams Brabant
- UZ Leuven - Leuven
Clichy
- Hopital Beaujon - Clichy
Hamburg
- Asklepios Klinik St. Georg - Hamburg
Tübingen
- Universitätsklinikum Tübingen - Tübingen
Łódź Voivodeship
- Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi - Lodz
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2022-03-03 |
| Est. Completion | 2028-05 |
| Phase | Phase 2 |
What NCT04775706 shows while recruiting
NCT04775706 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 184-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (90% lower).
The record links to 1 condition, with Short Bowel Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04775706 lists 13 locations in 8 states (Other, Massachusetts, Ohio).
Frequently Asked Questions
What is clinical trial NCT04775706 about?
NCT04775706 is a clinical study titled "Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects". 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).
What is the current status of trial NCT04775706?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 18 participants. The study started on 2022-03-03. Estimated completion is 2028-05.
What conditions does trial NCT04775706 study?
This clinical trial studies the following conditions: Short Bowel Syndrome.
What interventions are being tested in trial NCT04775706?
The interventions under investigation include: Placebo (DRUG), HM15912 Active (DRUG).
Who is sponsoring clinical trial NCT04775706?
This trial is sponsored by Hanmi Pharmaceutical Company Limited, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04775706 being conducted?
This trial has 13 study locations across Massachusetts, Ohio, Vlaams Brabant, Clichy, Hamburg. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04775706's enrollment target sits among peer trials
18 16th of 17 higher than 2 of 17 other Short Bowel Syndrome trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Short Bowel Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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