Endogenous Cushing's SyndromeLINC6NCT05382156
Non-interventional Study on Osilodrostat in Patients With Endogenous Cushing's Syndrome
An observational study of Endogenous Cushing's Syndrome, run by RECORDATI GROUP at 43 sites in 5 countries.
Trial summary
This is a non-interventional, multinational, multi-centre study with primary data collection, to further document the safety and efficacy of osilodrostat administered in routine clinical practice in patients treated with osilodrostat for endogenous Cushing's Syndrome Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endogenous Cushing's Syndrome
- What is being tested?
- Osilodrostat
- Type of treatment
- Pill or oral medicine
- How many people
- 206 participants
- Where
- 43 sitesin 5 countries
- Study dates
- 13 Jun 2022to Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The patient population will consist of adult male and female patients with endogenous Cushing's Syndrome. Eligible patients for the study must be treated with osilodrostat. Investigators need to ensure that patients enrolled in this study meet the study inclusion and exclusion criteria listed in the protocol.
Who may be able to join
- Written informed consent obtained prior to registration of any patient data
- Male or female patients aged 18 years or older with endogenous CS treated with osilodrostat. Treatment with osilodrostat can either be initiated at the first visit of the study or can have been initiated before screening.
Who cannot join
- Patients with exogenous CS
- Patients with Pseudo CS
- Patients participating in an interventional clinical trial with an investigational drug.
Trial locations and contacts
43 sites in 5 countries.
43 sites in 5 countries
United States15 sites
University of Michigan
Ann Arbor, Michigan, 48109
Emory University School
Atlanta, Georgia, 30322
Massachusetts General Hospital
Boston, Massachusetts, 02114-2696
Northwestern University
Chicago, Illinois, 60611
Endocrinology Research Associates, Inc.
Columbus, Ohio, 43201
St Elizabeth Physicians
Covington, Kentucky, 41011
Indiana University Schl-med
Indianapolis, Indiana, 46202
Froedtert Hospital
Milwaukee, Wisconsin, 53226
NYU Grossman School of Medicine
New York, New York, 10017
Memorial Sloan-Kettering Cancer Center (MSKCC) - New York
New York, New York, 10021
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, 19104
Barrow Neurological Institute
Phoenix, Arizona, 85013
Oregon Health And Science University
Portland, Oregon, 97239
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
Washington University School of Medicine
St Louis, Missouri, 63110
Germany11 sites
Charité Universitaetsmedizin Berlin
Berlin, 10117
Medicover Berlin-Mitte MVZ
Berlin, 10117
Medicover Köln
Cologne, 50939
Universitaet Bielefeld - Klinikum Bielefeld - Mitte
Düsseldorf
Universitaetsklinikum Frankfurt Goethe-Universitaet
Frankfurt, 60590
Endokrinologikum Frankfurt
Frankfurt, 60596
Amedes Experts
Hamburg, 20095
Medicover Neuroendokrinologie
Munich, 81667
Ludwig-Maximilians University of Munich
Munich
Medicover MVZ Oldenburg
Oldenburg, 26122
Universitaetsklinikum Wuerzburg
Würzburg, 97080
France10 sites
Hôpital Haut-Lévêque
Bordeaux, 33604
Hospices Civiles de Lyon
Bron, 69677
CHU de Grenoble site Nord
Grenoble, 38043
Groupement Hospitalier Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
Hopital Claude Huriez - CHRU Lille
Lille, 59037
Hopital de la Conception - APHM
Marseille, 13005
Hôpital de Brabois
Nancy, 54500
CHU de Nantes-Hopital Laennec
Nantes, 44800
Hôpital Cochin
Paris, 75679
Hopital Larrey
Toulouse, 31000
Italy5 sites
Azienda Ospedaliero Universitaria Ospedali Riuniti
Ancona, 60126
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, 20122
Azienda Ospedaliera Universitaria "Federico II"
Naples, 80131
Policlinico Umberto I
Roma, 00186
Azienda Ospedaliera Sant'Andrea-Università di Roma La Sapienza
Roma, 00189
Netherlands2 sites
Radboud University Nijmegen
Nijmegen, 6500
Erasmus MC
Rotterdam, 3015 GD
About this study
Official title: A Non-interventional Study to Assess the Long-term Safety and Efficacy of Osilodrostat in Patients With Endogenous Cushing's Syndrome
This is a non-interventional, multinational, multi-centre study with primary data collection, to further document the safety and efficacy of osilodrostat administered in routine clinical practice in patients treated with osilodrostat for endogenous Cushing's Syndrome
Read the detailed description
This is a non-interventional, multinational, multi-centre study with primary data collection, to further document the safety and efficacy of osilodrostat administered in routine clinical practice in patients treated with osilodrostat for endogenous Cushing's Syndrome. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule.
Patients with endogenous Cushing's Syndrome who are treated with osilodrostat alone or in combination with other therapies will be considered eligible for study enrolment. Each patient enrolled in the study will be followed up for 3 years from study entry. Patients who discontinue prior to the end of the 3-year period will be followed-up for 3 months after discontinuation of osilodrostat and will be included in the analysis.
The total number of patients enrolled in this study will be approximately 201. Assuming a recruitment period of 3 years, the total study duration from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) will be 6 years. The maximum duration for the individual patient is 3 years.
- Conditions
- Endogenous Cushing's Syndrome
- Being tested
- Osilodrostat
- Keywords
- Cushing's syndrome, Osilodrostat
- Medical subject headings
- Cushing Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsilodrostatDrug
Also called Isturisa
oral administration of Osilodrostat tablets at different doses according to patient's need
| Study group | Role | What they receive |
|---|---|---|
| Osilodrostat | Osilodrostat - tablets of 1mg, 5mg, 10mg - based on patients needs - up to 3 years Receives: Drug: Osilodrostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of osilodrostat-related adverse events and serious adverse events
Number of participants with Adverse Events and Serious Adverse Events
Measured: 3 years of treatment with osilodrostat
Secondary outcomes (32)
Short and long-term efficacy of osilodrostat
Complete response rate: proportion of enrolled patients with mean Urinary Free Cortisol (mUFC) ≤ ULN
Measured: at baseline before treatment start, after 1 month of treatment, then every 3 months in the first year and every 6 months thereafter through study completion up to three years
Short and long-term efficacy of osilodrostat
Partial response rate: proportion of enrolled patients with ≥ 50% reduction from baseline in mean urinary free cortisol (mUFC), (but mUFC > ULN)
Measured: at baseline before treatment start, after 1 month of treatment, then every 3 months in the first year and every 6 months thereafter through study completion up to three years
Short and long-term efficacy of osilodrostat
Overall response rate: proportion of enrolled patients with mean urinary free cortisol (mUFC) ≤ ULN or at least 50% reduction from baseline
Measured: at baseline before treatment start, after 1 month of treatment, then every 3 months in the first year and every 6 months thereafter through study completion up to three years
Changes in pituitary tumour size
Actual and percentage change from baseline in pituitary tumour size
Measured: at baseline before treatment start, after 6 months of treatment, then every 12 months through study completion up to three years
Incidence of Adverse Events (Safety and Tolerability)
Incidence of adverse events and laboratory abnormalities using the National Cancer Institute-Common Toxicology Criteria (NCI-CTC) grading scale (version 5.0).
Measured: 3 years of treatment with osilodrostat
Change of mean urinary free cortisol (mUFC)
Actual and percentage change from baseline in mean urinary free cortisol (mUFC)
Measured: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change of Serum Cortisol
Actual and percentage change from baseline in Serum Cortisol
Measured: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change of Late Salivary Cortisol
Actual and percentage change from baseline in Late Salivary Cortisol
Measured: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change of adrenocorticotropic hormone (ACTH)
Actual and percentage change from baseline in adrenocorticotropic hormone (ACTH)
Measured: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Normalization of Serum Cortisol
Proportion of patients achieving normalisation of Serum Cortisol
Measured: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Normalization of Late Salivary Cortisol
Proportion of patients achieving normalisation of Late Salivary Cortisol
Measured: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Normalization of adrenocorticotropic hormone (ACTH)
Proportion of patients achieving normalisation of adrenocorticotropic hormone (ACTH)
Measured: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change in Fasting Glucose
Actual and percentage change from baseline in fasting glucose
Measured: at baseline before treatment start, then every 3 months through study completion up to three years
Change in HbA1c
Actual and percentage change from baseline in HbA1c
Measured: at baseline before treatment start, then every 3 months through study completion up to three years
Change in Fasting Lipid Profile
Actual and percentage change from baseline in Fasting Lipid Profile
Measured: at baseline before treatment start, then every 3 months through study completion up to three years
Change in Serum Insulin
Actual and percentage change from baseline in Serum Insulin
Measured: at baseline before treatment start, then every 3 months through study completion up to three years
Change in Blood Pressure
Actual and percentage change from baseline in Blood Pressure
Measured: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change in Body Weight
Actual and percentage change from baseline in Body Weight
Measured: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change in Body Mass Index (BMI)
Actual and percentage change from baseline in Body Mass Index (BMI)
Measured: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change in Waist Circumference
Actual and percentage change from baseline in Waist Circumference
Measured: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change in Facial Rubor
Change from baseline in incidence and grade of severity at physical examination of the Cushing's syndrome clinical feature Facial Rubor
Measured: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Change in Hirsutism
Change from baseline in incidence and grade of severity at physical examination of the Cushing's syndrome clinical feature Hirsutism
Measured: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Change in Striae
Change from baseline in incidence and grade of severity at physical examination of the Cushing's syndrome clinical feature Striae
Measured: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Change in Supraclavicular fat pad
Change from baseline in incidence and grade of severity at physical examination of the Cushing's syndrome clinical feature Supraclavicular fat pad
Measured: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Change in Dorsal fat pad
Change from baseline in incidence and grade of severity at physical examination of the Cushing's syndrome clinical feature Dorsal fat pad
Measured: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Change in Proximal muscle wasting (atrophy)
Change from baseline in incidence and grade of severity at physical examination of the Cushing's syndrome clinical feature Proximal muscle wasting (atrophy)
Measured: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Change in Central (abdominal) obesity
Change from baseline in incidence and grade of severity at physical examination of the Cushing's syndrome clinical feature Central (abdominal) obesity
Measured: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Change in Ecchymoses (bruises)
Change from baseline in incidence and grade of severity at physical examination of the Cushing's syndrome clinical feature Ecchymoses (bruises)
Measured: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Changes in Patient-Reported Outcome (PRO) questionnaire Cushing Quality of Life (QoL)
Actual and percentage change from baseline in score of PRO questionnaire CushingQoL. The minimum and maximum values are 12 and 60 respectively, where higher score means a better outcome
Measured: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Changes in Patient-Reported Outcome (PRO) questionnaire Euro Quality of Life (EQ) - 5 Dimensions (5D) - 5 Levels (5L)
Actual and percentage change from baseline in score of PRO questionnaire EQ-5D-5L. The minimum and maximum values for the questions are 11111 and 55555 respectively, where higher score is a worst outcome. For the visual analogue scale minimum and maximum values are 0 and 100 respectively, where higher score means a better outcome
Measured: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Changes in Patient-Reported Outcome (PRO) questionnaire Beck Depression Inventory II (BDI-II)
Actual and percentage change from baseline in score of PRO questionnaire BDI-II. The minimum and maximum values are 1 and 63 respectively, where higher score means a worse outcome
Measured: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Changes in Patient-Reported Outcome (PRO) questionnaire Patient Global Impression of Change (PGIC)
Actual and percentage change in score of PRO questionnaire PGIC. The minimum and maximum values of the question are 1 and 7 respectively, where higher score means a better outcome. For the visual analogue scale minimum and maximum values are 0 and 10 respectively, where higher score means a worse outcome
Measured: after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start13 Jun 2022
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endogenous Cushing's SyndromeStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 206 participants (actual)
Sponsor and investigators
- Lead sponsor
- RECORDATI GROUP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mario Maldonado, MD, Study chair, Recordati AG - Head of Clinical Development
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382156
- Sponsor's protocol ID
- LCI699-RECAG-PASS-0572
- Acronym
- LINC6
- Status last verified
- Nov 2025
- First submitted
- 3 May 2022
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-interventional Study to Assess the Long-term Safety and Efficacy of Osilodrostat in Patients With Endogenous Cushing's Syndrome
- ClinicalTrials.gov ID
- NCT05382156
- Acronym / sponsor ID
- LINC6 / LCI699-RECAG-PASS-0572
- Conditions
- Endogenous Cushing's Syndrome
- Keywords
- Cushing's syndrome, Osilodrostat
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 206 participants (actual)
- Lead sponsor
- RECORDATI GROUPIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 19 May 2022 (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.
This is a non-interventional, multinational, multi-centre study with primary data collection, to further document the safety and efficacy of osilodrostat administered in routine clinical practice in patients treated with osilodrostat for endogenous Cushing's Syndrome
Detailed description
This is a non-interventional, multinational, multi-centre study with primary data collection, to further document the safety and efficacy of osilodrostat administered in routine clinical practice in patients treated with osilodrostat for endogenous Cushing's Syndrome. This study is observational in nature and does not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule.
Patients with endogenous Cushing's Syndrome who are treated with osilodrostat alone or in combination with other therapies will be considered eligible for study enrolment. Each patient enrolled in the study will be followed up for 3 years from study entry. Patients who discontinue prior to the end of the 3-year period will be followed-up for 3 months after discontinuation of osilodrostat and will be included in the analysis.
The total number of patients enrolled in this study will be approximately 201. Assuming a recruitment period of 3 years, the total study duration from First Patient First Visit (FPFV) to Last Patient Last Visit (LPLV) will be 6 years. The maximum duration for the individual patient is 3 years.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Osilodrostat | – | Drug: OsilodrostatOsilodrostat - tablets of 1mg, 5mg, 10mg - based on patients needs - up to 3 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The patient population will consist of adult male and female patients with endogenous Cushing's Syndrome. Eligible patients for the study must be treated with osilodrostat. Investigators need to ensure that patients enrolled in this study meet the study inclusion and exclusion criteria listed in the protocol.
Key inclusion criteria (2 listed)
- Written informed consent obtained prior to registration of any patient data
- Male or female patients aged 18 years or older with endogenous CS treated with osilodrostat. Treatment with osilodrostat can either be initiated at the first visit of the study or can have been initiated before screening.
Key exclusion criteria (3 listed)
- Patients with exogenous CS
- Patients with Pseudo CS
- Patients participating in an interventional clinical trial with an investigational drug.
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 |
|---|---|---|
| OsilodrostatAlso: Isturisaoral administration of Osilodrostat tablets at different doses according to patient's need | Drug | Osilodrostat |
Primary outcome
Incidence of osilodrostat-related adverse events and serious adverse events
Time frame: 3 years of treatment with osilodrostat
Number of participants with Adverse Events and Serious Adverse Events
32 secondary outcomes
Short and long-term efficacy of osilodrostat
Time frame: at baseline before treatment start, after 1 month of treatment, then every 3 months in the first year and every 6 months thereafter through study completion up to three years
Short and long-term efficacy of osilodrostat
Time frame: at baseline before treatment start, after 1 month of treatment, then every 3 months in the first year and every 6 months thereafter through study completion up to three years
Short and long-term efficacy of osilodrostat
Time frame: at baseline before treatment start, after 1 month of treatment, then every 3 months in the first year and every 6 months thereafter through study completion up to three years
Changes in pituitary tumour size
Time frame: at baseline before treatment start, after 6 months of treatment, then every 12 months through study completion up to three years
Incidence of Adverse Events (Safety and Tolerability)
Time frame: 3 years of treatment with osilodrostat
Change of mean urinary free cortisol (mUFC)
Time frame: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change of Serum Cortisol
Time frame: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change of Late Salivary Cortisol
Time frame: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change of adrenocorticotropic hormone (ACTH)
Time frame: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Normalization of Serum Cortisol
Time frame: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Normalization of Late Salivary Cortisol
Time frame: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Normalization of adrenocorticotropic hormone (ACTH)
Time frame: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change in Fasting Glucose
Time frame: at baseline before treatment start, then every 3 months through study completion up to three years
Change in HbA1c
Time frame: at baseline before treatment start, then every 3 months through study completion up to three years
Change in Fasting Lipid Profile
Time frame: at baseline before treatment start, then every 3 months through study completion up to three years
Change in Serum Insulin
Time frame: at baseline before treatment start, then every 3 months through study completion up to three years
Change in Blood Pressure
Time frame: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change in Body Weight
Time frame: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change in Body Mass Index (BMI)
Time frame: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change in Waist Circumference
Time frame: at baseline before treatment start, after 1 month of treatment, then every 3 months through study completion up to three years
Change in Facial Rubor
Time frame: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Change in Hirsutism
Time frame: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Change in Striae
Time frame: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Change in Supraclavicular fat pad
Time frame: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Change in Dorsal fat pad
Time frame: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Change in Proximal muscle wasting (atrophy)
Time frame: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Change in Central (abdominal) obesity
Time frame: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Change in Ecchymoses (bruises)
Time frame: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Changes in Patient-Reported Outcome (PRO) questionnaire Cushing Quality of Life (QoL)
Time frame: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Changes in Patient-Reported Outcome (PRO) questionnaire Euro Quality of Life (EQ) - 5 Dimensions (5D) - 5 Levels (5L)
Time frame: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Changes in Patient-Reported Outcome (PRO) questionnaire Beck Depression Inventory II (BDI-II)
Time frame: at baseline before treatment start, after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Changes in Patient-Reported Outcome (PRO) questionnaire Patient Global Impression of Change (PGIC)
Time frame: after 3 months of treatment, after 6 months of treatment, then every 6 months through study completion up to three years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: Yes
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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.
Mario Maldonado, MD study chair
Recordati AG - Head of Clinical Development
43 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endogenous Cushing's Syndrome, run by RECORDATI GROUP at 43 sites in 5 countries.
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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 43 sites in United States, Germany, France, Italy, Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of osilodrostat-related adverse events and serious adverse events (time frame: 3 years of treatment with osilodrostat). 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 20 Nov 2025.