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

What Was Tested

In this phase 2 trial, researchers set out to test Pasireotide.

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).

It had four arms (groups): one (experimental), one (experimental), one (experimental) and Placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Subjects with post-bariatric hypoglycemia will be screened for participation in this trial.

Eligible patients will complete the rest of the Core phase by entering a run-in period of 4 weeks without any treatment.

Participants will blindly self-administer their treatment for a total of 12 weeks when the primary endpoint will be assessed.

All participants completing the core phase will be offered to enter the extension phase.

Who Took Part

The registry lists 93 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or- non-pregnant female patients ≥ 18 years of age. Patients able to provide and have provided signed written informed consent prior to study participation. Patients capable of self-injecting subcutaneously. Specific training to self-inject the study drug will be provided. Post-bariatric surgery more than 6 months prior to screening. Patients must have ≥ 4 post-prandial hypoglycaemia during the 28-day run-in period (in average ≥1 event over a 7-day week) defined as:.

The full record lists 21 inclusion and 59 exclusion criteria; among the exclusions: bariatric patients who have lap band; patients with a current diagnosis of uncontrolled diabetes mellitus. however, diabetic patients in remission, as defined below, are eligible:; not taking any medications for hyperglycaemia for at least 3 months prior to screening.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Pasireotide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on Pasireotide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2024-01-04 with completion listed for 2026-10-29.

It ran at 29 sites in United States (10), Spain (7), Italy (4), United Kingdom (4), France (3) and Belgium (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 15 secondary outcomes, for example KEY SECONDARY_CORE PHASE: Evaluation the change of blood glucose nadir and peak during a mixed meal tolerance test (MMTT) at baseline, CORE PHASE: Evaluation of the change of blood glucose nadir and peak during a mixed meal tolerance test (MMTT) at baseline and the MMTT, CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (SF-36 score), CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (Dumping Score Questionnaire), CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (Patient Global Assessment) and CORE PHASE: Assessessment of the effect of pasireotide s.c. on HRQoL (Hypoglycaemia Fear Survey-II) from baseline.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Pasireotide in 93 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Pasireotide compound page, all human trials.