AcromegalyNCT07583563
An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly
An observational study of Acromegaly, run by Camurus AB at 6 sites in 2 countries.
Trial summary
The purpose of this study is to collect long-term (up to two years) safety and effectiveness of octreotide subcutaneous depot in patients with acromegaly in the real-world setting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Octreotide subcutaneous depot
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 5 Jun 2026to Jun 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will enroll patients with acromegaly who are considered for treatment with octreotide subcutaneous depot and patients with acromegaly who have already initiated octreotide subcutaneous depot treatment. The study will be conducted in Germany, the UK, and the US.
Who may be able to join
- Have started or will be starting treatment with octreotide SC depot for acromegaly
Who cannot join
- Have started or will be starting treatment with octreotide SC depot for other conditions not related to acromegaly
- Currently taking part in an interventional clinical trial or is still within a 30-day washout period from the end of taking part in an interventional clinical trial.
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Germany5 sites, 5 recruiting
- Recruiting
Universitaetsklinikum Aachen
Aachen, 52074
- Recruiting
Universitaetsklinikum Leipzig
Leipzig, 04103
- Recruiting
Fachpraxis für Innere Medizin, Endokrinologie und Diabetologie
Magdeburg, 39110
- Not yet recruiting
Medicover Neuroendokrinologie MVZ
München, 81667
- Recruiting
Universitätsklinikum Würzburg
Würzburg, 97080
United Kingdom1 site, 1 recruiting
- Not yet recruiting
St James's University Hospital - Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7TF
About this study
Official title: A Multi-Center, Multinational, Observational Study of Octreotide Subcutaneous Depot for the Treatment of Patients With Acromegaly
The purpose of this study is to collect long-term (up to two years) safety and effectiveness of octreotide subcutaneous depot in patients with acromegaly in the real-world setting.
- Conditions
- Acromegaly
- Being tested
- Octreotide subcutaneous depot
- Keywords
- Octreotide subcutaneous depot, Acromegaly, Observational, Real-world, Safety, Tolerability
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide subcutaneous depotDrug
Commercially available octreotide subcutaneous depot treatment administered by participants for a maximum duration up to 2 years in the study
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of octreotide SC depot-related AEs and SAEs during 2 years of treatment. Focus is on related AESIs and Other Safety Information.
Measured: From enrollment to the end of treatment at 2 years
Secondary outcomes (9)
Change in absolute IGF-1 levels and relative IGF-1 (IGF-1/ULN) over time.
Measured: From enrollment to the end of treatment at 2 years
Change in proportion of participants with IGF-1 ≤1×ULN over time.
Measured: From enrollment to the end of treatment at 2 years
Change in GH levels over time.
Measured: From enrollment to the end of treatment at 2 years
Change in proportion of participants with GH levels <1.0 μg/L over time.
Measured: From enrollment to the end of treatment at 2 years
Changes in symptoms of acromegaly over time, as measured by the Acromegaly Index of Severity (AIS) scale.
The clinician-reported AIS Overall Score ranges from 0 to 18, where a higher score indicates more severe symptoms.
Measured: From enrollment to the end of treatment at 2 years
Changes in QoL over time, as measured by the Acromegaly Quality of Life Questionnaire (AcroQoL).
The AcroQoL domain scores range from 0 to 100, where a higher score indicates better quality of life.
Measured: From enrollment to the end of treatment at 2 years
Changes in QoL over time, as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM).
The TSQM domain scores range from 0 to 100, where a higher score indicates greater treatment satisfaction.
Measured: From enrollment to the end of treatment at 2 years
Changes in QoL over time, as measured by the Assessment of Acromegaly Symptoms (AAS) questionnaire.
The patient-reported AAS total score ranges from 0 to 48, where a higher score indicates more severe symptoms.
Measured: From enrollment to the end of treatment at 2 years
Incidence of octreotide SC depot non-related AEs and incidence of laboratory abnormalities using the CTCAE grading scale.
Measured: From enrollment to the end of treatment at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start5 Jun 2026
- Primary completionJun 2029 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Camurus AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583563
- Sponsor's protocol ID
- HS-24-799
- Status last verified
- Sep 2026
- First submitted
- 27 Apr 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Individual data sharing
- No