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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Universitair Ziekenhuis Gent	Gent	Belgium
Centrum Medyczne Intercor Sp. z o.o.	Bydgoszcz	Poland
Semmelweis University	Budapest	Hungary
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
University Of Pecs	Pecs	Hungary
Centre Hospitalier Lyon Sud	Pierre Benite	France
Mooztaf Caiamp Aqrbk Iow Pzzjcoy Ezga	Sofia	Bulgaria

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.06.2021
Bulgaria	Not recruiting	01.06.2021
France	Not recruiting	01.06.2021
Hungary	Not recruiting	01.06.2021
Italy	Not recruiting	01.06.2021
Poland	Not recruiting	01.06.2021

Trial locations

Investigated drugs:

Paltusotine

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.

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.

Trial ID:

2024-511925-71-00

Protocol code:

CRN00808-09

NCT ID:

NCT04837040

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?