Study on the Effects of Paltusotine for Patients with Untreated Acromegaly

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What is this study about?

This clinical trial is focused on studying a condition called acromegaly. Acromegaly is a rare hormonal disorder that occurs when the pituitary gland produces too much growth hormone, leading to enlarged bones and tissues. The study will test a medication called paltusotine, which is taken in tablet form. Paltusotine is being compared to a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to evaluate how well paltusotine works in managing acromegaly in patients who have not been treated with medication for this condition. Participants in the study will be randomly assigned to receive either paltusotine or a placebo. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo during the trial.

Throughout the study, participants will take the assigned tablets and attend regular check-ups to monitor their health and the effects of the treatment. The study aims to see if paltusotine can help control the levels of a substance called IGF-1 in the body, which is often elevated in people with acromegaly. The trial will also assess any changes in symptoms related to acromegaly and overall well-being. The study is expected to continue until 2027, providing valuable information on the safety and effectiveness of paltusotine for treating acromegaly.

1 randomization

Upon joining the study, participants are randomly assigned to one of two groups. One group receives paltusotine tablets, and the other receives placebo tablets. This process is double-blind, meaning neither the participants nor the researchers know who is receiving which treatment.

2 medication administration

Participants take the assigned tablets orally. The dosage for paltusotine is 20 mg. The frequency and duration of administration are determined by the study protocol, which is designed to evaluate the effect of the medication on IGF-1 levels.

3 monitoring and assessments

Throughout the study, participants undergo regular monitoring to assess the biochemical response of IGF-1 levels. This includes measuring the proportion of participants who achieve a biochemical response in IGF-1 levels at the end of the randomized control phase.

Additional assessments include changes from baseline in IGF-1 levels, the proportion of participants achieving specific IGF-1 and GH levels, and changes in acromegaly symptoms as recorded in a diary.

4 end of randomized control phase

At the end of the randomized control phase, the primary endpoint is evaluated. This involves determining the proportion of participants who achieve a biochemical response in IGF-1 levels, defined as levels at or below the upper limit of normal.

Who Can Join the Study?

Willing and able to provide written informed consent before any study-related procedures. This means you agree to participate and understand what the study involves.
Willing and able to follow the study procedures and take the study treatment as instructed.
Must be 18 years or older at the time of screening and fit into one of the following groups:
- Medically naïve group (Group 1): Have not been treated with acromegaly medications before and have a specific level of a hormone called IGF-1. Must have had pituitary surgery at least 3 months before screening.
- Previously Treated group (Group 2): Last treated with acromegaly medications at least 4 months before screening and have a specific level of IGF-1.
- Washout group (Group 3): Currently on stable treatment with certain medications for at least 3 months before screening, have a specific level of IGF-1, and willing to stop medication during screening. IGF-1 levels must increase by a certain amount during screening to qualify.
Must have a previous diagnosis of acromegaly confirmed by a doctor, with documentation of a pituitary adenoma (a type of tumor).
If using thyroid hormone therapy, must be adequately treated and on a stable dose for at least 8 weeks before screening.
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 screening until 30 days after the last dose of the study drug.
Males must agree to use a condom when sexually active with a female partner who can have children from screening until 30 days after the last dose of the study drug, or be surgically sterile. They should also agree not to donate sperm during the study and for 30 days after the last dose.

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 characteristics required for the study.
Both male and female patients are eligible, so exclusion is not based on gender.
Patients who are considered part of a vulnerable population may be excluded. A vulnerable population includes groups that may have additional risks or need special protection in research.

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
Oncopole Claudius Regaud	Toulouse	France
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland

Other Sites

Site Name	City	Country
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
Centrum Medyczne Intercor Sp. z o.o.	Bydgoszcz	Poland
Hippokration Hospital	Athens	Greece
Evangelismos S.A.	Athens	Greece
Semmelweis University	Budapest	Hungary
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
University Of Pecs	Pecs	Hungary
Mxarwchmy Mknasoj gcgzt	Munich	Germany
Llfve Govtruv Hsmcxcys Od Aiomwd	Athens	Greece
Kgpbdyyk djf Urmpfqoljmjf Mysxpumv Ahv	Munich	Germany
Umojxsuegmsaywbrcclli Wygctwepf Atk	Wuerzburg	Germany
Mwzgosi Cimzmd Addct Iad Pwladme Erme	Sofia	Bulgaria

Trial status

Country	Status	Recruitment Start
Bulgaria	Not recruiting	09.12.2021
France	Not recruiting	09.12.2021
Germany	Not recruiting	09.12.2021
Greece	Not recruiting	09.12.2021
Hungary	Not recruiting	09.12.2021
Italy	Not recruiting	09.12.2021
Poland	Not recruiting	09.12.2021

Trial locations

Investigated drugs:

Paltusotine

Paltusotine is a medication being studied for its potential to treat acromegaly, a condition characterized by excessive growth hormone production. The trial aims to assess how well paltusotine can control levels of a hormone called IGF-1, which is often elevated in people with acromegaly. The study is focused on individuals who have not received other treatments for this condition.

Acromegaly – Acromegaly is a hormonal disorder that develops when the pituitary gland produces too much growth hormone. This excess hormone causes bones and tissues to grow larger than normal, leading to noticeable changes in physical appearance. Common symptoms include enlarged hands and feet, facial changes such as a protruding jaw or enlarged nose, and thickened skin. Over time, individuals may experience joint pain, headaches, and vision problems due to the pressure of enlarged tissues. The condition progresses slowly, often taking years for symptoms to become apparent. It is typically diagnosed in middle-aged adults, although it can occur at any age.

Trial ID:

2024-511924-15-00

Protocol code:

CRN00808-08

NCT ID:

NCT05192382

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Paltusotine for Patients with Untreated Acromegaly

What is this study about?

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