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Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia

NCT05928390 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 93

Last updated 2025-09-22

No results posted yet for this 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).

Conditions

  • Post-Bariatric Hypoglycemia

Interventions

DRUG

Pasireotide Diaspartate

Injectable ampoules

Sponsors & Collaborators

  • RECORDATI GROUP

    lead INDUSTRY

Principal Investigators

  • Arnd H MUELLER, MD · Recordati AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-04
Primary Completion
2026-04-30
Completion
2026-04-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Italy
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05928390 on ClinicalTrials.gov