ClinicalTrials.gg
CompletedNCT05131100Updated Jul 23, 2026

Korean Regulatory Post Marketing Surveillance for Somavert

An observational study in Acromegaly, sponsored by Pfizer. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-23.

Sponsored by Pfizer · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
11
Ages
18 Years and older
Sex
All
01

Study summary

Non-interventional observational study, to identify safety and effectiveness of Somavert during the post-marketing period based on the Korean RMP as required by the regulations of Ministry of Food and Drug Safety (MFDS)

02

Conditions studied

  • Acromegaly

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Keywords

  • acromegaly, Somavert, Post-Marketing Surveillance
03

In context

Acromegaly

202 studies on the registry are indexed under Acromegaly; 19 are open to participants now.

This study's enrollment of 11 is below the median of 100 across 81 observational studies indexed under Acromegaly.

Browse Acromegaly studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult acromegaly patients who have had an inadequate response to surgery and/or radiation therapy and in whom appropriate medical treatment with somatostatin analogues did not normalize IGF-1 concentrations or was not tolerated

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

All patients who have been prescribed as per local label and investigators' judgement under the setting of routine practice in Korea who are eligible.

Exclusion criteria

Exclusion Criteria:

Patients who are for Somavert

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
11 participants (actual)
Patient registry
No

Groups and cohorts

  • Participants receiving Somavert

    Drug: Somavert

Interventions

  • As provided in real world practice

06

What researchers measure

Primary outcomes

  1. Number of participants who experience adverse events

    Time frame: Baseline through 28 days after last dose (approximately 52 weeks)

Secondary outcomes

  1. Number of participants who experience Clinical Improvement as assessed by investigator

    Time frame: Baseline through approximately 52 weeks

07

Study locations

1 site
  • Pfizer
    Seoul, South Korea
08

References and documents

Individual participant data

Plan to share: No — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05131100
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Nov 23, 2021
Start date
Jul 13, 2022
Primary completion
Nov 10, 2025
Completion
Nov 10, 2025
Last update
Jul 23, 2026

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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