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Acromegaly – Trials in Disease

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Ongoing Clinical Trials for Acromegaly

There are currently 7 clinical trials underway across Europe testing new treatments for acromegaly, a condition where the body produces too much growth hormone. These studies are evaluating several investigational medications, including long-acting formulations of existing treatments and entirely new drug candidates, with the goal of improving hormone control and quality of life for patients. Trials are being conducted in 16 countries, offering opportunities for participation to eligible individuals at various stages of their treatment journey.

Clinical trial locations

Study of Debio 4126, a new octreotide formulation, compared to placebo in patients with acromegaly who were previously treated with somatostatin analogs

This trial evaluates Debio 4126, a new formulation of octreotide designed to last 12 weeks between injections. The study focuses on patients who have already been treated with somatostatin analogs and aims to determine whether this longer-acting formulation can effectively maintain normal insulin-like growth factor 1 (IGF-1) levels.

Main inclusion criteria: Participants must be at least 18 years old and currently receiving treatment with octreotide or lanreotide for at least 6 months, with no dose changes in the past 12 weeks. IGF-1 levels must be within normal limits at the screening visit, and patients must have a confirmed diagnosis based on study requirements. Normal functioning of bone marrow, liver, and kidneys is also required.

Main exclusion criteria: The study excludes people below 18 or above 75 years of age, pregnant or breastfeeding women, and those with a history of severe allergic reactions to similar medications. Other exclusions include uncontrolled diabetes, active or recent serious infections, severe liver or kidney problems, history of cancer in the past 5 years (except treated skin cancer), recent participation in other clinical trials, mental conditions that could interfere with study procedures, uncontrolled high blood pressure, serious heart conditions, substance abuse, and inability to follow study procedures.

Study focus: The trial consists of an initial 36-week treatment period where participants are randomly assigned to receive either Debio 4126 injections every 12 weeks, placebo injections, or open-label Debio 4126. Blood tests are performed at weeks 34 and 36 to measure IGF-1 levels. Patients with normalized levels may continue to a second treatment period. Throughout the study, doctors monitor vital signs, heart rhythm, pituitary tumor size, and injection site reactions.

Investigational drugs: The primary medication being tested is Debio 4126, a new 12-week formulation of octreotide. The trial also involves octreotide, a well-established somatostatin analog medication used to regulate hormone production in the body.

Study on the Effects of Pegvisomant and Somatropin on Liver Fat Metabolism in Patients with Acromegaly and Healthy Individuals

This trial investigates how growth hormone affects liver fat metabolism in both people with acromegaly and healthy individuals. The study uses two medications: pegvisomant (brand name SOMAVERT) and somatropin (brand name Genotropin), both administered through subcutaneous injections.

Main inclusion criteria: Participants must be between 18 and 70 years of age. For healthy volunteers, plasma triglycerides (a type of fat in the blood) must be less than 300 mg/dl, and only males are eligible in this group.

Main exclusion criteria: The study excludes individuals with certain medical conditions. Healthy individuals only can participate, meaning no ongoing medical conditions. Age restrictions apply, and both men and women can participate, though certain gender-specific health conditions may exclude participants. Vulnerable populations requiring special protection or care are not eligible.

Study focus: The research aims to understand how growth hormone influences the liver’s ability to process fats and energy. Participants receive either the medication or a placebo, and researchers observe changes in energy use, liver fat content, and the production of certain types of fat in the liver. The study also examines how these changes affect overall body composition and energy expenditure. The trial is expected to end by January 2025.

Investigational drugs: The trial studies growth hormone to understand how it affects liver fat metabolism and the release of certain types of fat into the blood, potentially providing insights into liver health and fat metabolism in healthy people.

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

This is a long-term extension study evaluating the safety and effectiveness of paltusotine (also known by its code name CRN00808), which is taken as oral tablets. The study is open-label, meaning all participants know they are receiving the medication, and it continues for an extended period to gather comprehensive data.

Main inclusion criteria: Participants must have completed one of the previous studies called Acrobat Evolve or Acrobat Edge. Females must not be pregnant or breastfeeding and should either be surgically sterile, post-menopausal, or using effective birth control methods. All patients must provide signed informed consent.

Main exclusion criteria: Pregnant or breastfeeding women cannot participate. The study also excludes individuals with other serious health conditions that might interfere with the trial, those who have had recent surgery or are planning surgery soon, current participants in another clinical trial, people with allergies to the study medication or its ingredients, individuals without a diagnosis, those unable to follow study procedures or attend scheduled visits, and patients with a history of drug or alcohol abuse. Certain abnormal lab test results may also exclude participants.

Study focus: The trial monitors the long-term safety of paltusotine by tracking treatment-emergent adverse events 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. The study is expected to end in February 2028, having begun recruiting in February 2020.

Investigational drugs: CRN00808 (paltusotine) is being studied for its long-term safety and effectiveness in managing symptoms over an extended period.

Study of ALXN2420 with somatostatin analogs for adults with acromegaly to evaluate effectiveness in lowering IGF-1 levels

This study evaluates ALXN2420, a new medication used together with existing somatostatin analog treatments (octreotide acetate or lanreotide acetate). The research focuses on determining whether this combination can help lower IGF-1 hormone levels in people when combined with standard treatments.

Main inclusion criteria: Participants must be between 18 and 80 years old with a confirmed diagnosis documented by MRI scan or tissue examination. They must be currently taking long-acting somatostatin analog (SSA) medication at the maximum or highest tolerable dose for at least 6 months, receiving treatment once every month. Patients must show a partial response to SSA therapy, with IGF-1 levels decreased by more than 20% while on treatment. IGF-1 levels must be at least 1.3 times but not more than 5 times higher than the normal upper limit, confirmed by two separate blood tests taken at least 7 days apart.

Main exclusion criteria: The study excludes people with a history of pituitary surgery within 6 months before starting the study, radiation therapy to the pituitary gland within the last 10 years, or previous treatment with growth hormone receptor blockers in the past 6 months. Other exclusions include severe or uncontrolled high blood pressure, history of heart attack or stroke in the past 6 months, severe liver or kidney problems, active or chronic infections, current cancer diagnosis or cancer treatment within the past 5 years, pregnant or breastfeeding women, participation in another clinical trial within 30 days, known allergies to similar medications, unstable mental health conditions, alcohol or drug abuse within the past year, and any condition that would make participation unsafe.

Study focus: The treatment period lasts 15 weeks, during which participants receive either ALXN2420 or placebo through subcutaneous injections while continuing their regular SSA treatment. Throughout the study, IGF-1 levels are monitored, and participants complete questionnaires about symptoms and quality of life. Blood tests check the concentration of the study medication, and health status is monitored for side effects. At week 15, final measurements and health evaluations are performed.

Investigational drugs: ALXN2420 is an experimental growth hormone receptor antagonist designed to block the effects of growth hormone in the body, given as a subcutaneous injection. Somatostatin analogs (SSAs) are medications that help control hormone production by reducing the release of growth hormone, used in combination with ALXN2420 in this trial.

Study of long-term safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly

This trial focuses on CAM2029, a new form of octreotide administered as a subcutaneous injection (under the skin) rather than the traditional deep intramuscular injection. The study evaluates how safe and well-tolerated this new formulation is when used long-term.

Main inclusion criteria: Participants must be 18 years or older, able to give written consent, and have a confirmed diagnosis with historical evidence showing persistent or recurring condition. They must be currently taking a stable dose of octreotide LAR or lanreotide ATG for at least 3 months as the only treatment. IGF-1 levels must be either above normal but not more than 2 times the upper limit, or at or below normal limits with or without previous radiation therapy. Normal liver, pancreas, kidney, and bone marrow function is required, along with a normal ECG (heart rhythm test). For the extension part, patients must complete the main study, attend the Week 52 visit, and provide new written consent.

Main exclusion criteria: The study excludes people with a history of pituitary surgery within 6 months before starting, pituitary radiation therapy within the past 2 years, known allergic reactions to similar medications, significant heart, liver, or kidney disease, uncontrolled diabetes, active or chronic infection (including hepatitis B, hepatitis C, or HIV), current treatment with other medications for the condition, pregnancy or breastfeeding, participation in another clinical trial within the past 30 days, inability to follow study procedures, history of drug or alcohol abuse within the past year, major surgery planned during the study, mental health conditions that could interfere with participation, and cancer diagnosis or treatment within the past 5 years (except for certain skin cancers).

Study focus: The study consists of a main part lasting 52 weeks, followed by an extension period. During treatment, participants receive regular subcutaneous injections of CAM2029 at doses up to 20 mg per day, with the total amount not exceeding 520 mg over the study period. Throughout the trial, blood tests measure hormone levels (IGF-1 and GH), quality of life questionnaires are completed, and health is monitored through regular check-ups. Side effects are recorded at each visit, and gallbladder examinations are performed during the extension phase. The study is expected to end by May 2025.

Investigational drugs: CAM2029 is a long-acting subcutaneous depot formulation of octreotide, a synthetic somatostatin analog that works by suppressing excessive growth hormone production from the pituitary gland. This new formulation offers a more convenient dosing schedule compared to conventional octreotide formulations.

Study on the Effects of Paltusotine for Patients with Untreated Acromegaly

This double-blind trial evaluates paltusotine, taken in tablet form, compared to a placebo. The study focuses on patients who have not been treated with medication for their condition or who have previously been treated but discontinued treatment.

Main inclusion criteria: Participants must be willing to provide written consent and follow study procedures, and be 18 years or older. They must fit into one of three groups: medically naïve (never treated with medications before, with pituitary surgery at least 3 months before screening); previously treated (last treated at least 4 months before screening); or washout group (currently on stable treatment for at least 3 months, willing to stop medication during screening, with IGF-1 levels increasing by a certain amount during screening). All must have a previous diagnosis confirmed by documentation of a pituitary adenoma. If using thyroid hormone therapy, patients must be adequately treated and on a stable dose for at least 8 weeks. Females who have heterosexual intercourse must use effective birth control methods, and males must agree to use condoms or be surgically sterile and not donate sperm during the study and for 30 days after.

Main exclusion criteria: The study excludes individuals without a diagnosis, those not within the specified age range, patients not part of the specified clinical trial groups, those not willing to follow study procedures, patients with other medical conditions that might interfere with the study, pregnant or breastfeeding women, those taking medications that might interfere with the study drug, and patients who have participated in another clinical trial recently.

Study focus: Participants are randomly assigned to receive either paltusotine (20 mg tablets) or placebo in a double-blind design. Throughout the study, regular monitoring assesses the biochemical response of IGF-1 levels. Additional assessments include changes from baseline in IGF-1 levels, the proportion of participants achieving specific IGF-1 and GH levels, and changes in symptoms as recorded in a diary. At the end of the randomized control phase, the primary endpoint evaluates the proportion of participants who achieve normal or below-normal IGF-1 levels. The study is expected to continue until 2027.

Investigational drugs: Paltusotine is being tested to determine if it can effectively manage the levels of IGF-1 hormone in patients who have not received other treatments for their condition.

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

This randomized, double-blind trial evaluates paltusotine taken in tablet form compared to a placebo. The study focuses on understanding how well paltusotine works in managing symptoms and maintaining normal IGF-1 levels in patients already on stable treatment with somatostatin analogs.

Main inclusion criteria: Participants must be willing to provide written consent, follow study procedures, and take the study treatment as directed. They must be adults 18 years or older with a stable condition, currently on a stable dose of long-acting octreotide or lanreotide for at least 12 weeks before the study starts, with treatment ongoing for at least 24 weeks. All must have a previous diagnosis confirmed by documentation of a pituitary tumor diagnosed by imaging or tissue examination at least 24 weeks before the study starts. If the patient had pituitary surgery, high IGF-1 levels must be documented at least 12 weeks after the surgery (which must have been done at least 24 weeks before the study starts). Average IGF-1 levels must be within a specific range during screening, based on 2 or 3 separate measurements. Participants must be willing to have biliary/gallbladder ultrasound and pituitary MRI scans. If using thyroid hormone therapy, patients must be adequately treated and on a stable dose for at least 8 weeks. Females must use effective birth control methods, and males must agree to use condoms or be surgically sterile and not donate sperm during the study and for 30 days after.

Main exclusion criteria: The study excludes patients without a diagnosis, those not within the specified age range, patients not part of the specified clinical trial groups, those not willing to follow study procedures, patients with other medical conditions that might interfere with the study, pregnant or breastfeeding women, those taking medications that might interfere with the study drug, and patients who have participated in another clinical trial recently.

Study focus: During the screening phase, participants undergo assessments including blood tests to measure IGF-1 levels, biliary/gallbladder ultrasound, and pituitary MRI to ensure eligibility. In the randomized control phase, participants are assigned to receive either paltusotine tablets or matching placebo orally. Regular monitoring of IGF-1 levels and other health parameters occurs throughout the treatment period, which may extend until June 2027. At the end of the randomized control phase, the biochemical response in IGF-1 levels is evaluated to determine treatment effectiveness, along with changes in growth hormone levels and symptoms.

Investigational drugs: Paltusotine is being tested to determine if it can be a safe and effective treatment option for managing the condition and improving quality of life. Long-acting somatostatin receptor ligands are standard medications used to control symptoms and hormone levels, typically given as injections that work over a longer period.

Summary

The current landscape of clinical trials for acromegaly shows a diverse range of investigational approaches, with 7 active studies across 16 European countries. A notable concentration of trials is evident in Germany, Hungary, Italy, and Poland, which each host multiple studies, suggesting robust research infrastructure and patient populations in these regions.

Three trials are evaluating paltusotine, an oral medication representing a potential shift from injectable treatments, which could offer improved convenience for patients. Two studies focus on long-acting formulations of octreotide (Debio 4126 and CAM2029), aiming to extend the dosing interval and potentially improve patient compliance. The ALXN2420 trial takes a combination approach, testing a growth hormone receptor antagonist alongside standard somatostatin analog therapy.

The trials encompass various patient populations, from treatment-naïve individuals to those already on stable therapy, as well as long-term extension studies for ongoing safety monitoring. Study durations vary considerably, with some completing in 2025 and others extending to 2029, reflecting both short-term efficacy assessments and long-term safety evaluations. Most trials measure IGF-1 levels as a primary endpoint, along with quality of life assessments and symptom monitoring, providing comprehensive data on both biochemical control and patient well-being.

Ongoing Clinical Trials on Acromegaly

  • Study of Debio 4126, a new octreotide formulation, compared to placebo in patients with acromegaly who were previously treated with somatostatin analogs

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Belgium Bulgaria Denmark Estonia France +10

  • Study on the Effects of Pegvisomant and Somatropin on Liver Fat Metabolism in Patients with Acromegaly and Healthy Individuals

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria

  • Study of ALXN2420 with somatostatin analogs for adults with acromegaly to evaluate effectiveness in lowering IGF-1 levels

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Denmark Hungary Italy Lithuania The Netherlands Poland +1

  • Study of long-term safety of octreotide subcutaneous depot (CAM2029) in patients with acromegaly

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany Hungary Italy Poland Spain

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