NCT05401578 Canakinumab for the Treatment of Postprandial Hypoglycemia
| NCT ID | NCT05401578 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Postprandial Hypoglycemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 56 participants |
| Start Date | 2023-04-17 |
| Primary Completion | 2026-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 56 participants in total. It began in 2023-04-17 with a primary completion date of 2026-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The primary objective of this randomized trial is to test whether a treatment with canakinumab is superior to placebo in patients with postprandial hypoglycemia after bariatric surgery, that is if it improves health related quality of life (mentally or physically) or reduces the risk of hypoglycemic events.
Eligibility Criteria
Inclusion Criteria: * Patients after bariatric surgery (i.e. sleeve gastrectomy, Roux-en-Y gastric bypass, omega-loop bypass, biliopancreatic diversion) with documented hypoglycemia, i. e. \< 3.0 mmol/l and at least 5 hypoglycemic episodes per week despite dietary modification * For women with child-bearing potential, willingness to use contraceptive measures adequate to prevent pregnancy during the study * Informed Consent as documented by signature Exclusion Criteria: * Any type of diabetes mellitus according to ADA criteria * Intolerance to the study drug * Signs of current infection * Any use of immunosuppressive medication * Use of any drug therapy for postbariatric hypoglycemia apart from acarbose (all remaining drugs have to be discontinued four half-life times before screening phase) * Neutropenia (leukocyte count \< 1.5 × 109/L or ANC \< 0.5 × 109/L) * Anemia (hemoglobin \< 11 g/dL for males, \< 10 g/dL for females) * Clinically significant kidney or liver disease (creatinine \> 1.5 mg/dL, AST/ALT \> 2 × ULN, alkaline phosphatase \> 2 × ULN, or total bilirubin \[tBili\] \> 1.5 × ULN) * Uncontrolled congestive heart failure * Uncontrolled malignant disease * Currently pregnant or breastfeeding * Known or suspected non-compliance, drug or alcohol abuse * Meeting the criteria for vulnerability (e.g. participants incapable of judgment or participants under tutelage) * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. * Participation in another clinical trial using investigational drugs in the last 30 days or planned participation in the next 60 days * Previous enrolment into the current study, * Enrolment of the investigator, his/her family members, employees and other dependent persons
Contact & Investigator
Marc Y Donath, Prof. Dr.
PRINCIPAL INVESTIGATOR
University of Basel
Frequently Asked Questions
Who can join the NCT05401578 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Postprandial Hypoglycemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05401578 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 56 participants.
Is NCT05401578 currently recruiting?
Yes, NCT05401578 is actively recruiting participants. Contact the research team at marc.donath@usb.ch for enrollment information.
Where is the NCT05401578 trial being conducted?
This trial is being conducted at Basel, Switzerland, Olten, Switzerland.
Who is sponsoring the NCT05401578 clinical trial?
NCT05401578 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Marc Y Donath, Prof. Dr. at University of Basel. The trial plans to enroll 56 participants.