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NCT05928390 · ClinicalTrials.gov registry record · Phase 2
Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
A Phase 2 study of Post-Bariatric Hypoglycemia, sponsored by Recordati Group.
- Active
- Registry status
- Phase 2
- Development phase
- 93
- Enrollment target
- 20
- Study locations
NCT05928390: Active Phase 2 study of Post-Bariatric Hypoglycemia, sponsored by Recordati Group.
NCT05928390 is a Phase 2 study of Post-Bariatric Hypoglycemia that is active but no longer recruiting, run by Recordati Group. The registered enrollment target is 93 participants, above the 37-participant average among 4 other Post-Bariatric Hypoglycemia trials with a reported enrollment target (151% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05928390, a Phase 2 study of Post-Bariatric Hypoglycemia, is active but no longer recruiting, sponsored by Recordati Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 93 participants
- Enrollment target
- 20
- Study locations
Study Summary
The Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods * 19 weeks for the Core Phase. It is composed of: * a Screening period: a maximum of 3 weeks * a Run-in period (no treatment): 4 weeks * a Blinded Treatment Phase: 12 weeks * 36 weeks Extension Phase = an open-label Treatment period * 4 weeks for the safety follow-up period (without any treatment).
Primary Outcome
Change in the blood glucose levels, as measured by the peak to nadir glucose AUC during MMTT
Conditions Studied
Interventions
- DRUG Pasireotide Diaspartate
Study Locations (20)
Other
- Universitaire Ziekenhuizen Leuven, Department of Gastroenterology and Hepatology,Herestraat 49 - Leuven
- AP-HP Hopital Europeen Georges Pompidou, 20, rue Leblanc, - Paris
- HCL Centre Hospitalier Lyon Sud - Pierre-Bénite
- Hopital Rangueil, Attachée de Recherche Clinique, Centre Investigation Clinique, CHU, Cedex 9, France - Toulouse
- IRCCS Azienda Ospedaliero-Universitaria di Bologna - Policlinico di Sant Orsola - Bologna
- Azienda Ospedale - Università Padova, Clinica Medica 3, Via Giustiniani, 2, - Padua
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone - Palermo
- Fondazione Policlinico Universitario A. Gemelli IRCCS - Universita Cattolica del Sacro Cuore, L.go Gemelli 8 - Rome
- Hospital Universitario Vall d'Hebron, Passeig Vall d´Hebron 119-129, Spain - Barcelona
- Hospital Clinic Barcelona, Lipid Clinic End, Nutr. Service Hospital Clinic, C. Villarroel, 170, - Barcelona
California
- Stanford University School of Medicine, Endocrinology, 800 Welch Road, - Palo Alto
Illinois
- Northwestern University - Feinberg School of Medicine - Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Louisiana
- NOLA Care - Metairie
Maryland
- Velocity Clinical Research - Annapolis - Annapolis
Massachusetts
- Joslin Diabetes CenterJoslin Diabetes Center, One Joslin Place - Boston
Minnesota
- Mayo Clinic - Rochester, 200 First Street, SW, 55905 - Rochester
New York
- Montefiore Medical Center, 111 E 210th Street, - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2024-01-04 |
| Est. Completion | 2026-04 |
| Phase | Phase 2 |
What the registry record for NCT05928390 still lists
NCT05928390 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 93 participants, a relatively small participant target, above the 37-participant average among 4 other Post-Bariatric Hypoglycemia trials with a reported enrollment target (151% higher).
The record links to 1 condition, with Post-Bariatric Hypoglycemia appearing as the primary indexed condition, and to 1 intervention - of which Pasireotide Diaspartate is the first listed.
NCT05928390 names 20 study sites across 11 states, led by Other, California, Illinois.
Frequently Asked Questions
What is clinical trial NCT05928390 about?
NCT05928390 is a clinical study titled "Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia". The Total duration of trial participation for each participant with post-bariatric hypoglycemia will be a maximum of 59 weeks, with the following duration of trial periods * 19 weeks for the Core Phase. It is composed of: * a Screening period: a maximum of 3 weeks * a Run-in period (no treatme...
What is the current status of trial NCT05928390?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 93 participants. The study started on 2024-01-04. Estimated completion is 2026-04.
What conditions does trial NCT05928390 study?
This clinical trial studies the following conditions: Post-Bariatric Hypoglycemia.
What interventions are being tested in trial NCT05928390?
The interventions under investigation include: Pasireotide Diaspartate (DRUG).
Who is sponsoring clinical trial NCT05928390?
This trial is sponsored by Recordati Group, which has 11 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05928390 being conducted?
This trial has 20 study locations across California, Illinois, Louisiana, Maryland, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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