Not recruitingRare disease

Study on the Safety and Effectiveness of Paltusotine for Patients with Acromegaly

Fast replyInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying the condition known as acromegaly, a disorder that results from the body producing too much growth hormone, leading to enlarged bones and other tissues. The study will evaluate the safety and effectiveness of a new treatment called paltusotine, which is taken in tablet form. Paltusotine is being compared to a placebo to understand its impact on the levels of a protein called IGF-1, which is often elevated in people with acromegaly.

The purpose of the study is to assess how well paltusotine works in managing acromegaly symptoms and maintaining normal IGF-1 levels. Participants in the study will be randomly assigned to receive either paltusotine or a placebo. The study will involve regular check-ups and monitoring over a period of time to observe any changes in the condition and to ensure the safety of the participants. The study will also look at changes in symptoms and other health markers related to acromegaly.

Throughout the study, participants will continue to receive care and support from the study team. The trial aims to provide valuable information on whether paltusotine can be a safe and effective treatment option for people living with acromegaly. This research is important for developing new ways to manage this condition and improve the quality of life for those affected.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will begin by providing written consent to confirm understanding and agreement to participate in the trial.
The participant must be an adult with a confirmed diagnosis of acromegaly and have been on a stable dose of long-acting octreotide or lanreotide for at least 12 weeks prior to the start of the study.
Step 2
Screening phase
During the screening phase, the participant will undergo various assessments, including blood tests to measure IGF-1 levels, which should be within a specific range.
The participant will also have a biliary/gallbladder ultrasound and a pituitary MRI to ensure eligibility for the study.
Step 3
Randomized control phase
In this phase, the participant will be randomly assigned to receive either paltusotine tablets or a placebo that matches the paltusotine tablets in appearance.
The medication is administered orally in the form of tablets. The specific dosage and frequency will be determined by the study protocol.
Step 4
Treatment duration
The participant will continue the assigned treatment for the duration specified in the study protocol, which may extend up to the estimated end date of the trial in June 2027.
Regular monitoring of IGF-1 levels and other health parameters will occur throughout the treatment period to assess the safety and efficacy of the treatment.
Step 5
End of randomized control phase
At the end of the randomized control phase, the participant's biochemical response in IGF-1 levels will be evaluated to determine the effectiveness of the treatment.
Additional assessments may include changes in growth hormone levels and symptoms related to acromegaly.

Who can join the trial?

9 criteria

Willing and able to provide written consent before any study-related procedures.
Willing and able to follow the study procedures and take the study treatment as directed.
Must be an adult, 18 years or older, with a stable condition of **acromegaly** (a condition where the body produces too much growth hormone) and currently on a stable dose of long-acting **octreotide** or **lanreotide** (medications used to treat acromegaly) for at least 12 weeks before the study starts. Treatment with these medications must have been ongoing for at least 24 weeks before the study starts.
Must have a previous diagnosis of acromegaly confirmed by a doctor, with documentation of a **pituitary tumor** (a growth in the pituitary gland) diagnosed by imaging or tissue examination at least 24 weeks before the study starts. If the patient had pituitary surgery, there must be documentation of **IGF-1** (a hormone related to growth) levels being high at least 12 weeks after the surgery, which must have been done at least 24 weeks before the study starts. If no surgery was done, high IGF-1 levels must be documented at least 24 weeks before the study starts.
Must have average IGF-1 levels within a specific range during the screening process, based on 2 or 3 separate measurements.
Willing and able to have a **biliary/gallbladder ultrasound** (a scan of the gallbladder) and a **pituitary MRI** (a detailed scan of the pituitary gland) during the screening and study.
If using **thyroid hormone therapy** (medication for thyroid issues), the patient should be adequately treated and on a stable dose for at least 8 weeks before the study starts.
Females who have heterosexual intercourse must either be unable to have children (due to surgery or menopause) or agree to use effective birth control methods from the start of the study until at least 30 days after the last dose of the study drug.
Males must agree to use a condom during sexual activity with a female partner who can have children from the start of the study until at least 30 days after the last dose of the study drug. Alternatively, they can be surgically sterile or abstain from sexual activity. Males should also agree not to donate sperm during the study and for at least 30 days after the last dose of the study drug.

Who cannot join the trial?

8 criteria

Patients who are not diagnosed with acromegaly cannot participate. Acromegaly is a condition where the body produces too much growth hormone, leading to enlarged bones and tissues.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are not part of the specified clinical trial groups cannot participate. This refers to specific categories or groups that the study is focusing on.
Patients who are not willing to follow the study procedures or take the study medication cannot participate.
Patients who have other medical conditions that might interfere with the study cannot participate. This means if you have other health issues that could affect the study results, you may not be eligible.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients who are taking medications that might interfere with the study cannot participate. Some medications can affect how the study drug works.
Patients who have participated in another clinical trial recently cannot participate. This is to avoid any interference from other study treatments.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centre Hospitalier Lyon Sud
Pierre Benite, France
Responsive
Semmelweis University
Budapest, Hungary
Responsive
Universitair Ziekenhuis Gent
Gent, Belgium

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Paltusotine
is a medication being studied for its potential to help people with acromegaly, a condition where the body produces too much growth hormone. This medication is being tested to see if it can effectively manage the levels of a hormone called IGF-1, which is often high in people with acromegaly. The study aims to determine if paltusotine can be a safe and effective treatment option for these patients.
Long-acting Somatostatin Receptor Ligands
are medications commonly used to treat acromegaly. They work by mimicking a natural hormone in the body called somatostatin, which helps to reduce the production of growth hormone. These medications are typically given as injections and are designed to work over a longer period, helping to control symptoms and hormone levels in people with acromegaly.

Paltusotine

What is already known about the treatment

Paltusotine – Paltusotine is administered orally and is currently being studied in clinical trials for its effectiveness in treating acromegaly, a condition characterized by excessive growth hormone. The medication is in the investigational stage, with ongoing research to determine its safety and efficacy. It works by targeting somatostatin receptors, which play a role in regulating growth hormone levels. Paltusotine belongs to the pharmacological class of somatostatin receptor ligands, which are used to manage conditions involving hormone overproduction.

Investigated diseases

Acromegaly – Acromegaly is a rare hormonal disorder that occurs when the pituitary gland produces too much growth hormone. This excess hormone causes the bones in the hands, feet, and face to increase in size. The condition develops slowly, and changes in appearance can be subtle and occur over several years. Common symptoms include enlarged hands and feet, facial changes such as a protruding jaw or enlarged nose, and thickened skin. Over time, acromegaly can lead to joint pain, headaches, and vision problems. It is often diagnosed in middle-aged adults, but symptoms can appear at any age.