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Study on the Effects of Pasireotide in Patients with Low Blood Sugar After Bariatric Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Post-Bariatric Hypoglycemia (PBH), which can occur in some individuals after they have undergone weight-loss surgery. This condition is characterized by low blood sugar levels after eating, which can lead to symptoms like dizziness, confusion, and even fainting. The study is testing a treatment called Pasireotide Diaspartate, which is a type of medication that mimics a natural hormone in the body to help control blood sugar levels. The medication is given as a solution for injection under the skin.

The purpose of the study is to evaluate how effective and safe Pasireotide Diaspartate is in managing blood sugar levels in patients with PBH. Participants in the study will receive either the medication or a placebo, which is an inactive substance, to compare the effects. The study will last for a period of 12 weeks, during which participants will be monitored for changes in their blood sugar levels and any side effects they may experience. The study aims to find the most effective dose of the medication that can help manage the symptoms of PBH.

Throughout the study, participants will undergo regular assessments to track their blood sugar levels and overall health. These assessments will help researchers understand how Pasireotide Diaspartate affects the body and its potential benefits for people with Post-Bariatric Hypoglycemia. The study is designed to provide valuable information that could lead to better treatment options for individuals experiencing this condition after bariatric surgery.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will receive training on how to self-inject the study medication. This training is essential for the administration of the medication throughout the trial.

  2. Step 2

    Medication administration

    The patient will be randomly assigned to receive either pasireotide or a placebo. The medication is administered as a subcutaneous injection, which means it is injected under the skin.

    The dosage of pasireotide will be either 50 micrograms, 100 micrograms, or 200 micrograms, taken three times a day (tid). The placebo will be administered with the same frequency.

  3. Step 3

    Treatment duration

    The initial treatment phase lasts for 12 weeks. During this period, the patient will continue to self-administer the assigned medication or placebo as instructed.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, the patient's blood glucose levels will be monitored. This includes measuring changes in blood glucose levels from the start of the trial to the end of the 12-week treatment period.

    The patient will also be assessed for the frequency and severity of hypoglycemic events, which are episodes of low blood sugar.

  5. Step 5

    Extension phase

    After the initial 12-week period, there is an optional extension phase. This phase allows for continued treatment and monitoring for up to 48 weeks.

    During the extension phase, the same monitoring and assessments will continue to ensure the safety and efficacy of the treatment.

  6. Step 6

    End of trial

    The trial is expected to conclude by February 2026. At the end of the trial, final assessments will be conducted to evaluate the overall outcomes of the treatment.

Who can join the trial?

21 criteria

  • Must be a male or a non-pregnant female who is 18 years or older.
  • Must have stopped any previous treatments for **Post-Bariatric Hypoglycaemia (PBH)**, such as acarbose, gama guar, pectin, or diazoxide, for at least 2 weeks before the study.
  • Must not have used **GLP-1 antagonists** or **GLP-1 agonists** for at least 4 weeks before the study. These are medications that affect blood sugar levels.
  • Must not have used **SGLT2 inhibitors** for at least 4 weeks before the study. These are medications that help the body remove excess sugar through urine.
  • If previously treated with **somatostatin receptor analogues**, must wait a specific time before starting the study, depending on the type of medication used:
  • **Octreotide s.c.**: wait at least 3 days
  • **Octreotide LAR**: wait at least 8 weeks
  • **Lanreotide Autogel**: wait at least 14 weeks
  • **Lanreotide SR**: wait at least 4 weeks
  • **Pasireotide s.c.**: wait at least 3 days
  • **Pasireotide LAR**: wait at least 12 weeks
  • Must be able to provide signed written consent to participate in the study.
  • Must be able to self-inject the study medication under the skin. Training will be provided.
  • Must have had **bariatric surgery** more than 6 months before joining the study. Bariatric surgery is a type of surgery to help with weight loss.
  • Must have a documented diagnosis of **Post-Bariatric Hypoglycaemia (PBH)**, with low blood sugar levels and symptoms that improve after eating carbohydrates.
  • Must have experienced at least 4 episodes of low blood sugar after meals during a 28-day period, defined as:
  • Blood sugar less than 54 mg/dL
  • Symptoms of **neuroglycopenia**, which means the brain is not getting enough sugar
  • Severe low blood sugar event
  • Must have tried controlling symptoms with diet, but it was not enough.
  • Must have a **Karnofsky Performance Status** of 60 or higher, meaning they may need some help but can take care of most personal needs. This is a scale used to measure a person's ability to perform daily activities.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with Post-Bariatric Hypoglycaemia (a condition where blood sugar levels drop too low after weight-loss surgery) cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who belong to a clinical trial group that is not included in this study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
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Investigated drugs

Pasireotide is a medication being studied for its ability to help manage blood sugar levels in patients who experience low blood sugar after undergoing bariatric surgery. This condition is known as Post-Bariatric Hypoglycaemia (PBH). The trial aims to determine how effective and safe pasireotide is when given as a subcutaneous injection over a period of 12 weeks.

What is already known about the treatment

Pasireotide – This medication is administered via subcutaneous injection. It is currently being studied in clinical trials for its effectiveness in treating Post-Bariatric Hypoglycaemia. The main therapeutic indication is to manage low blood sugar levels in patients who have undergone bariatric surgery. Pasireotide works by mimicking somatostatin, a hormone that inhibits the release of several other hormones, thereby helping to regulate blood sugar levels. It is classified as a somatostatin analog in pharmacology.

Investigated diseases

Post-Bariatric Hypoglycemia – This condition occurs in some individuals who have undergone bariatric surgery, a procedure to aid weight loss. It is characterized by episodes of low blood sugar, or hypoglycemia, which can happen after eating. The condition arises due to changes in how the body processes food, leading to excessive insulin production. Symptoms may include shakiness, sweating, confusion, and in severe cases, loss of consciousness. These episodes typically occur one to three hours after meals. The condition can significantly impact daily life, requiring careful management of diet and lifestyle.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505316-37-00Protocol codeSOM230-RECAG-CL-0576Estimated enrolment72 patientsSponsorRecordati AG

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