AcromegalyNCT05131100
Korean Regulatory Post Marketing Surveillance for Somavert
An observational study of Acromegaly, run by Pfizer at 1 site in South Korea.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acromegaly
- What is being tested?
- Somavert
- How many people
- 11 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jul 2022to 10 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 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
Who may be able to join
- All patients who have been prescribed as per local label and investigators' judgement under the setting of routine practice in Korea who are eligible.
Who cannot join
- Patients who are contraindicated for Somavert
Trial locations and contacts
1 site in 1 country.
About this study
Official title: KOREAN POST-MARKETING SURVEILLANCE FOR SOMAVERT
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)
- Conditions
- Acromegaly
- Being tested
- Somavert
- Keywords
- acromegaly, Somavert, Post-Marketing Surveillance
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SomavertDrug
As provided in real world practice
| Study group | Role | What they receive |
|---|---|---|
| Participants receiving Somavert | Not described Receives: Drug: Somavert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who experience adverse events
Measured: Baseline through 28 days after last dose (approximately 52 weeks)
Secondary outcomes (1)
Number of participants who experience Clinical Improvement as assessed by investigator
Measured: Baseline through approximately 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start13 Jul 2022
- Primary completion10 Nov 2025
- Study completion10 Nov 2025
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.
- More trials run by PfizerThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131100
- Sponsor's protocol ID
- A6291047
- Other IDs
- NCT05131100
- Status last verified
- Jul 2026
- First submitted
- 10 Nov 2021
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- KOREAN POST-MARKETING SURVEILLANCE FOR SOMAVERT
- ClinicalTrials.gov ID
- NCT05131100
- Acronym / sponsor ID
- A6291047
- Conditions
- Acromegaly
- Keywords
- acromegaly, Somavert, Post-Marketing Surveillance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 10 Nov 2025 (actual)
- Study completion
- 10 Nov 2025 (actual)
- First posted
- 23 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants receiving Somavert | – | Drug: Somavert |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- All patients who have been prescribed as per local label and investigators' judgement under the setting of routine practice in Korea who are eligible.
Key exclusion criteria (1 listed)
- Patients who are contraindicated for Somavert
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SomavertAs provided in real world practice | Drug | Participants receiving Somavert |
Primary outcome
Number of participants who experience adverse events
Time frame: Baseline through 28 days after last dose (approximately 52 weeks)
1 secondary outcome
Number of participants who experience Clinical Improvement as assessed by investigator
Time frame: Baseline through approximately 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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RecruitingPhase 3
A Study to Assess the Efficacy and Safety of Debio 4126 in Participants With Acromegaly Previously Treated With Somatostatin Analogs
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An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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Managing Pasireotide-associated Hyperglycaemia in Acromegaly With Ketogenic Diet
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromegaly, run by Pfizer at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who experience adverse events (time frame: Baseline through 28 days after last dose (approximately 52 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.