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
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.