Not recruitingRare disease

Study on the Long-Term Safety and Efficacy of Paltusotine for Patients with Acromegaly

Verified siteInvestigationalNo placebo

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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 the condition known as acromegaly, a disorder that results from the body producing too much growth hormone, leading to enlarged bones and tissues. The treatment being tested in this study is a medication called paltusotine, which is taken in the form of tablets. Paltusotine is also known by its code name, CRN00808.

The purpose of this study is to evaluate the long-term safety and effectiveness of paltusotine in individuals with acromegaly. Participants in the study will take paltusotine tablets orally. The study will monitor the safety of the medication by observing any side effects that occur during the trial. Additionally, the study will assess how well paltusotine works by measuring changes in levels of certain hormones, such as insulin-like growth factor 1 (IGF-1) and growth hormone (GH), which are typically elevated in acromegaly.

This study is an open-label, long-term extension, meaning that all participants will know they are receiving paltusotine, and the study will continue for an extended period to gather comprehensive data on the medication's effects. The trial aims to provide valuable insights into the management of acromegaly with paltusotine, potentially offering a new treatment option for those affected by this condition.

The research process

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

Step 1
Joining the study
Participation begins after completing one of the parent studies, either Acrobat Evolve or Acrobat Edge.
Eligibility requires non-pregnant and non-lactating females to be surgically sterile, post-menopausal, or using effective birth control methods.
Informed consent must be provided.
Step 2
Medication administration
The medication used in this study is paltusotine, administered in the form of tablets.
The tablets are taken orally. The specific dosage and frequency are determined by the study protocol and the healthcare provider.
Step 3
Monitoring and assessments
The primary focus is on the incidence of treatment-emergent adverse events (TEAEs) throughout the study.
Secondary assessments include changes in insulin-like growth factor 1 (IGF-1) levels and growth hormone (GH) levels after 15 weeks of treatment.
Step 4
Study duration
The study is a long-term extension, with an estimated end date of February 28, 2028.
The study began recruiting participants on February 26, 2020.

Who can join the trial?

3 criteria

The patient must have completed one of the previous studies called Acrobat Evolve or Acrobat Edge.
Females must not be pregnant or breastfeeding. They should either be surgically sterile, which means they have had an operation to prevent pregnancy, be post-menopausal, meaning they have stopped having periods naturally, or be using effective birth control methods.
The patient must be willing to provide signed informed consent, which means they agree to participate in the study after being fully informed about it.

Who cannot join the trial?

9 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with other serious health conditions that might interfere with the study cannot join.
Patients who have had a recent surgery or are planning to have surgery soon are not eligible.
People who are currently participating in another clinical trial cannot take part in this study.
Individuals who have allergies to the study medication or its ingredients are excluded.
Patients who have not been diagnosed with acromegaly cannot participate. Acromegaly is a condition where the body produces too much growth hormone, leading to enlarged bones and tissues.
Individuals who are unable to follow the study procedures or attend scheduled visits are not eligible.
Patients with a history of drug or alcohol abuse may be excluded from the study.
Individuals who have certain abnormal lab test results that could affect the study are not eligible.

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Verified sites

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

EVAGGELISMOS"General Hospital of Athens
Verified
Athens, Greece
Ippokratio General Hospital Of Thessaloniki
Verified
Thessaloniki, Greece
Semmelweis University
Responsive
Budapest, Hungary

Trial locations

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Investigated drugs

CRN00808: This medication is being studied for its long-term safety and effectiveness in treating acromegaly, a condition where the body produces too much growth hormone. The trial aims to see how well patients tolerate this medication over an extended period and how effective it is in managing the symptoms of acromegaly.

Paltusotine

What is already known about the treatment

Paltusotine – Paltusotine is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating acromegaly, a condition characterized by excessive growth hormone. It is not yet widely available in medical practice, as it is still under investigation. The medication works by selectively targeting and inhibiting the receptor for growth hormone-releasing hormone, thereby reducing the production of growth hormone. Paltusotine is classified as a non-peptide somatostatin receptor agonist, which helps manage hormone levels in patients with acromegaly.

Investigated diseases

Acromegaly – Acromegaly is a hormonal disorder that develops when the pituitary gland produces excess growth hormone. This condition typically occurs in adults and leads to the enlargement of bones and tissues, most noticeably in the hands, feet, and face. Over time, individuals may experience joint pain, thickened skin, and changes in facial features. The progression of acromegaly is gradual, often taking years before noticeable symptoms appear. It can also lead to complications such as diabetes and high blood pressure if left unchecked. The condition is often caused by a benign tumor on the pituitary gland.