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Short-Acting Pasireotide Test to Predict Treatment Response in Patients with Acromegaly

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The trial focuses on Acromegaly, a rare condition in which the body makes too much growth hormone, leading to enlarged hands, feet, and facial features. The study tests a short‑acting version of the medicine pasireotide given as a subcutaneous injection (an injection under the skin) to see if it can predict how well patients will respond to the longer‑acting form of the same drug, known as Signifor®.

Participants receive a low dose of the injection on the first day and a higher dose on the fourth day. Blood samples are taken just before each injection and at several points up to three hours afterward to measure levels of growth hormone and insulin-like growth factor 1, another hormone that reflects disease activity. Imaging of the tumor with MRI may also be compared to the hormone results. The study follows participants for about three months to determine cut‑off values that separate those who are likely to have a strong, weak, or intermediate response to the long‑acting treatment.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    You attend the first study visit after joining the trial. during this visit you receive information about the study and sign a consent form confirming that you agree to take part.

    Baseline measurements are taken, including a blood draw to assess your current levels of growth hormone (gh) and insulin-like growth factor 1 (igf-1).

  2. Step 2

    Day 1 injection and blood sampling

    On the first day you receive a subcutaneous injection of pasireotide at a dose of 0.3 mg. the injection is given under the skin by a study nurse.

    A blood sample is taken 10 minutes before the injection to measure your baseline insulin-like growth factor 1 (igf-1) level.

    Additional blood samples are taken immediately after the injection (time 0), at 1 hour, at 2 hours, and at 3 hours. these samples are used to measure the concentration of pasireotide in your blood and the level of growth hormone (gh).

    The growth hormone (gh) level measured at 2 and/or 3 hours after the injection helps determine how your body responds to the medication.

  3. Step 3

    Day 4 injection and blood sampling

    On day four you receive a second subcutaneous injection of pasireotide, this time at a dose of 0.6 mg.

    A blood sample is taken 10 minutes before this injection to measure your insulin-like growth factor 1 (igf-1) level again.

    Blood samples are again taken at time 0, 1 hour, 2 hours, and 3 hours after the injection to assess pasireotide concentration and growth hormone (gh) levels.

    The growth hormone (gh) measurements at 2 and/or 3 hours are compared with the earlier results to evaluate the overall response.

  4. Step 4

    Follow‑up period

    After the two injection days you continue in the study for a follow‑up period of three months.

    During this time the study team may collect additional information about your health and any side effects, but no further injections of pasireotide are given as part of this test.

Who can join the trial?

6 criteria

  • Must have a diagnosis of acromegaly (a condition where the body makes too much growth hormone, leading to enlarged hands, feet, and facial features).
  • Must be between 18 and 85 years old.
  • Must have had brain surgery (neurosurgery) for acromegaly that did not cure the disease, or must have taken the first type of medicines called first‑generation somatostatin receptor ligands (fg SRLs) for at least six months at the full dose, but still not have normal levels of a hormone called IGF‑1 (a protein that indicates how much growth hormone is active).
  • Must have been or currently be treated with pasireotide (Signifor®) LAR (a long‑acting injection used for acromegaly) either alone or together with other medicines called pegvisomant and/or cabergoline. The patient must have shown one of these responses: a complete response, a partial response (IGF‑1 level drops more than 50 % but is still not normal), or an incomplete response (IGF‑1 level drops less than 50 %).
  • Women must be either post‑menopausal (no menstrual periods for at least one year) or women who could become pregnant (women of childbearing potential). They must agree not to become pregnant during the study. If sexually active, they must use a highly effective birth‑control method such as hormonal pills, an intra‑uterine device (IUD), or permanent sterilization for themselves or their partner. All women must agree to take a urine pregnancy test on the day of treatment and before each injection of the study drug, which is given under the skin (subcutaneous).
  • Must understand the study information and be able to sign the informed consent form to agree to take part.

Who cannot join the trial?

9 criteria

  • Renal insufficiency: kidney problems that cause a low filtering ability, measured as a glomerular filtration rate (GFR) below 40 mL per minute.
  • Hepatic cirrhosis or severe liver damage (called Child‑Pugh Class C), meaning the liver is badly scarred and not working well.
  • Oncologic diseases with active treatment: having cancer and currently receiving chemotherapy, radiation, or other cancer therapies.
  • Undernutrition defined by a very low body‑mass index (BMI under 17), which indicates the person is dangerously underweight.
  • Diabetes mellitus with poor metabolic control: blood‑sugar control is poor when the A1c level is higher than 9%.
  • Being pregnant, trying to become pregnant, or breastfeeding at the time of enrollment.
  • Severe psychiatric disorders: serious mental health conditions that could affect safety or study participation.
  • Participating in another clinical study that uses drugs for acromegaly.
  • Having a history of serious allergic reaction or strong side‑effects (hypersensitivity) to the study drug pasireotide.
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Investigated drugs

  • Pasireotide (short‑acting)

    is a medication given as a subcutaneous injection that works quickly to lower growth hormone levels in the body. In this study, it is used as a short‑acting test to see how a patient’s growth hormone responds right after the injection. The result helps doctors predict whether a longer‑acting version of the drug will be effective for that patient.

  • Pasireotide LAR (Signifor)

    is a long‑acting injectable form of the same medication. It is given less often, usually once a month, and is used as a regular treatment to control excess growth hormone in people with acromegaly. The study uses the short‑acting test to identify patients who are likely to have a good, partial, or poor response to this long‑acting therapy.

What is already known about the treatment

Pasireotide - Pasireotide is administered by subcutaneous injection, available as a short‑acting form for testing and a long‑acting depot for treatment. It is an approved medication that is already used in clinical practice and described in many scientific studies. The drug is mainly used to lower growth‑hormone levels in patients with acromegaly, a rare hormonal disease. It works by binding to somatostatin receptors, especially type 5, on pituitary cells, which blocks the release of growth hormone, and it belongs to the class of somatostatin analogues.

Investigated diseases

Acromegaly - Acromegaly is a condition caused by excess growth hormone, usually due to a benign tumor in the pituitary gland. It leads to gradual enlargement of the hands, feet, and facial features. Over time, internal organs such as the heart and liver may also increase in size. The disease often develops slowly, with symptoms becoming more noticeable over several years. If untreated, the physical changes tend to continue progressing.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-524253-14-00Protocol codePATEstimated enrolment40 patientsSponsorInstituto De Investigacion En Ciencias De La Salud Germans Trias I Pujol

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