Current partner codePEPTIDESDE
NCT07583563·Not applicable·OBSERVATIONAL

An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly

Status

Recruiting

Phase

Not applicable

Enrollment

200

Locations

5

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

Octreotide subcutaneous depot

Commercially available octreotide subcutaneous depot treatment administered by participants for a maximum duration up to 2 years in the study

Timeline

From registration to results.

  1. First posted

    May 13, 2026

  2. Study start

    Jun 5, 2026

  3. Primary completion

    Jun 2029

  4. Study completion

    Jun 2029

  5. Results posted

    Not reported

  6. Registry updated

    Jun 30, 2026

Outcomes

What the study measures.

Primary outcomes

Incidence of octreotide SC depot-related AEs and SAEs during 2 years of treatment. Focus is on related AESIs and Other Safety Information.

Time frame · From enrollment to the end of treatment at 2 years

Secondary outcomes

Change in absolute IGF-1 levels and relative IGF-1 (IGF-1/ULN) over time.

Time frame · From enrollment to the end of treatment at 2 years

Change in proportion of participants with IGF-1 ≤1×ULN over time.

Time frame · From enrollment to the end of treatment at 2 years

Change in GH levels over time.

Time frame · From enrollment to the end of treatment at 2 years

Change in proportion of participants with GH levels <1.0 μg/L over time.

Time frame · 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.

Time frame · From enrollment to the end of treatment at 2 years

The clinician-reported AIS Overall Score ranges from 0 to 18, where a higher score indicates more severe symptoms.

Changes in QoL over time, as measured by the Acromegaly Quality of Life Questionnaire (AcroQoL).

Time frame · From enrollment to the end of treatment at 2 years

The AcroQoL domain scores range from 0 to 100, where a higher score indicates better quality of life.

Changes in QoL over time, as measured by the Treatment Satisfaction Questionnaire for Medication (TSQM).

Time frame · From enrollment to the end of treatment at 2 years

The TSQM domain scores range from 0 to 100, where a higher score indicates greater treatment satisfaction.

Changes in QoL over time, as measured by the Assessment of Acromegaly Symptoms (AAS) questionnaire.

Time frame · From enrollment to the end of treatment at 2 years

The patient-reported AAS total score ranges from 0 to 48, where a higher score indicates more severe symptoms.

Incidence of octreotide SC depot non-related AEs and incidence of laboratory abnormalities using the CTCAE grading scale.

Time frame · From enrollment to the end of treatment at 2 years

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Have started or will be starting treatment with octreotide SC depot for acromegaly Exclusion Criteria: * 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.

Study locations

5 registered sites.

Germany. Showing up to 24 locations stored in the fast local snapshot.

Universitaetsklinikum Aachen

Aachen, Germany

Universitaetsklinikum Leipzig

Leipzig, Germany

Fachpraxis für Innere Medizin, Endokrinologie und Diabetologie

Magdeburg, Germany

Medicover Neuroendokrinologie MVZ

München, Germany

Universitätsklinikum Würzburg

Würzburg, Germany

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Octreotide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.