NCT07583563

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
36mo left

Started May 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress2%
May 2026May 2029

First Submitted

Initial submission to the registry

April 27, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2029

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

3 years

First QC Date

April 27, 2026

Last Update Submit

May 8, 2026

Conditions

Keywords

Octreotide subcutaneous depotAcromegalyObservationalReal-worldSafetyTolerability

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

  • +4 more secondary outcomes

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acromegaly

Condition Hierarchy (Ancestors)

Bone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEndocrine System Diseases

Central Study Contacts

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

May 1, 2026

Primary Completion (Estimated)

May 1, 2029

Study Completion (Estimated)

May 1, 2029

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share