An Observational Study of Octreotide Subcutaneous Depot in Patients With Acromegaly

NCT07583563 | Recruiting

• 1 other identifier: HS-24-799
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Acromegaly

Keywords

Octreotide subcutaneous depot; Acromegaly; Observational; Real-world; Safety; Tolerability

Outcome Measures

Primary Outcomes (1)

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

  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.

  From enrollment to the end of treatment at 2 years

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

  From enrollment to the end of treatment at 2 years

• Change in GH levels over time.

  From enrollment to the end of treatment at 2 years

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

  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.

  From enrollment to the end of treatment at 2 years

Interventions

Octreotide subcutaneous depot DRUG

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Have started or will be starting treatment with octreotide SC depot for acromegaly

You may not qualify if:

• 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.

Sponsors & Collaborators

• Camurus AB: lead

Study Sites (5)

Universitaetsklinikum Aachen

Aachen, 52074, Germany

NOT YET RECRUITING

Universitaetsklinikum Leipzig

Leipzig, 04103, Germany

RECRUITING

Fachpraxis für Innere Medizin, Endokrinologie und Diabetologie

Magdeburg, 39110, Germany

NOT YET RECRUITING

Medicover Neuroendokrinologie MVZ

München, 81667, Germany

NOT YET RECRUITING

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, Endocrine; Bone Diseases; Musculoskeletal Diseases; Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Central Study Contacts

Camurus AB

CONTACT

+46 46 286 57 30; medicalinfo@camurus.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 13, 2026
• Study Start: June 5, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: June 30, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)