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

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What is this study about?

This clinical trial focuses on patients with acromegaly, a condition where the body produces too much growth hormone, leading to abnormal growth of body tissues. The study tests a medication called CAM2029, which contains octreotide and is given as an injection under the skin. This new form of the medication is being developed to help control acromegaly symptoms over a long period.

The main purpose of this study is to evaluate how safe and well-tolerated CAM2029 is when used long-term in people with acromegaly. The medication is administered as a subcutaneous injection, which means it is given under the skin. The study consists of two parts: a main part lasting 52 weeks, followed by an extension period for additional long-term observation.

During the study, participants receive regular doses of CAM2029. The treatment can be given at doses up to 20 mg per day, with the total amount over the study period not exceeding 520 mg. Throughout the study, doctors monitor various aspects of participants’ health, including how well their acromegaly symptoms are controlled and their overall well-being.

1 Initial evaluation and medication start

Your condition, acromegaly, will be evaluated through medical tests

You will start receiving CAM2029, a medication given by injection under the skin

Your liver, kidney, pancreas function and heart rhythm (ECG) will be checked

2 Regular treatment phase – first 52 weeks

You will receive regular subcutaneous injections of CAM2029

Your blood will be tested to measure hormone levels (IGF-1 and GH)

You will complete questionnaires about your quality of life and satisfaction with treatment

Your health will be monitored through regular check-ups

Side effects will be recorded during each visit

3 Week 52 evaluation

A thorough evaluation of your health status will be performed

Your hormone levels will be measured

Your quality of life and treatment satisfaction will be assessed

A decision about continuing to the extension phase will be made

4 Extension phase

If you continue to the extension phase, you will receive ongoing CAM2029 treatment

Regular monitoring will continue with blood tests and health checks

Quality of life assessments will continue

Additional questionnaires about work productivity will be completed

Your gallbladder will be examined through imaging

5 Final evaluation

A final assessment of your health status will be performed

All test results will be reviewed

The study is expected to end by May 31, 2025

Who Can Join the Study?

Age 18 years or older
Must be able to give written consent to participate in the study
Must have a confirmed diagnosis of acromegaly with historical evidence showing persistent or recurring condition
Must be currently taking a stable dose of octreotide LAR or lanreotide ATG (medications used to treat acromegaly) for at least 3 months as the only treatment
Must have specific IGF-1 levels (Insulin-like Growth Factor 1, a hormone that indicates acromegaly activity) that are either:
- Above normal but not more than 2 times the upper limit of normal, OR
- At or below normal limits with or without previous radiation therapy to the pituitary gland
Must have normal liver, pancreas, kidney, and bone marrow function
Must have a normal ECG (heart rhythm test)
For the extension part of the study:
- Must complete the main part of the study
- Must attend the Week 52 visit
- Must provide new written consent for the extension phase

Who Cannot Join the Study?

History of pituitary surgery (surgery on a small gland in the brain) within 6 months before starting the study
Pituitary radiation therapy (radiation treatment targeting the pituitary gland) within the past 2 years
Known allergic reactions to medications similar to the study drug
Significant heart, liver, or kidney disease
Uncontrolled diabetes (high blood sugar levels)
Active or chronic infection, including hepatitis B, hepatitis C, or HIV
Current treatment with other medications for acromegaly
Pregnancy or breastfeeding
Participation in another clinical trial within the past 30 days
Any condition that, in the opinion of the study doctor, would make participation unsafe
Unable to follow study procedures or attend scheduled visits
History of drug or alcohol abuse within the past year
Major surgery planned during the study period
Mental health conditions that could interfere with study participation
Cancer diagnosis or treatment within the past 5 years (except for certain skin cancers)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy

Other Sites

Site Name	City	Country
Central Hospital Of Northern Pest Military Hospital	Budapest	Hungary
Hospital General Universitario Gregorio Maranon	Madrid	Spain
Azienda Ospedaliera di Padova	Padua	Italy
Virgen del Rocío University Hospital	Sevilla	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
University Of Szeged	Szeged	Hungary
Medicover GmbH	Oldenburg In Holstein	Germany
Hmrbigks Usaxjgfxwkzbq Dc Lg Pqmjqntn	Madrid	Spain
Medquwqfh Mkgqcry glbwd	Munich	Germany
Krrojsjz dsf Udrwtoqforah Mpevodas Arm	Munich	Germany
Hsmqfcsx Voau dwtvywfz	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	10.10.2019
Hungary	Not recruiting	10.10.2019
Italy	Not recruiting	10.10.2019
Poland	Not recruiting	10.10.2019
Spain	Not recruiting	10.10.2019

Trial locations

Investigated drugs:

Octreotide Hydrochloride

CAM2029 (octreotide subcutaneous depot) is a long-acting medication used to treat acromegaly, a condition where the body produces too much growth hormone. It is administered as an injection under the skin. This medication helps control hormone levels and reduce symptoms associated with acromegaly. It is a new formulation of octreotide that allows for subcutaneous (under the skin) administration instead of the traditional deep intramuscular injection.

Investigated diseases:

Acromegaly

Acromegaly – A rare hormonal disorder that develops when the pituitary gland produces too much growth hormone during adulthood. The excess growth hormone leads to gradual enlargement of body tissues, including bones of the face, jaw, hands, and feet. The condition typically develops slowly over many years, causing gradual changes in facial features, enlarged hands and feet, and widened spaces between teeth. Internal organs may also increase in size, and patients might experience joint pain, increased sweating, and fatigue. The disorder can also cause other complications such as high blood pressure, diabetes, and sleep problems.

Trial ID:

2024-510667-33-00

Protocol code:

HS-19-647

NCT ID:

NCT04125836

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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