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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04775706
The ClinicalTrials.gov registry entry for NCT04775706 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 18 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 184-participant average among 17 other Short Bowel Syndrome trials with a reported enrollment target (90% lower). The listed sponsor is Hanmi Pharmaceutical Company Limited, which has 25 total studies on file at ClinicalTrials.gov.
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 reports 13 study locations spanning 8 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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