Cushing's SyndromeLINC7NCT05633953

Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome

An observational study of Cushing's Syndrome, run by RECORDATI GROUP at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Cushing's Syndrome
What is being tested?: Osilodrostat
Type of treatment: Pill or oral medicine
How many people: 103 participants
Where: 1 siteFrance
Study dates: 16 Jan 2023to 30 Oct 2023
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 study population will consist of patients with non-CD CS. Patients meeting eligibility criteria will be retrospectively identified and included in the study by site investigators based on a review of medical records at site. Site policies and local regulations regarding patient consent (NOL) will be followed. All eligible patients identified at a site between April 2019 and study start date and consenting to be part of the study will be included.

Who may be able to join

Male and female patients ≥18 years old with diagnosis of CS, except for CD (i.e., an aetiology of adrenal adenoma, adrenocortical carcinoma, adrenal hyperplasia, or ectopic adrenocorticotropic hormone secretion). Patients should have a contemporaneously documented diagnosis of CS as per effective guidelines.
Patients treated with osilodrostat between April 2019 and study start date as part of ATU programme or commercialisation.

Who cannot join

Patients who participated in a clinical trial anytime during the study period.
Patients with Pseudo-Cushing's syndrome, cyclic CS, or iatrogenic CS.

Trial locations and contacts

1 site in 1 country.

France1 site

Hôpital Haut-Lévèque
Pessac, 33604

Other trials in France

About this study

Official title: A Retrospective Observational Study to Evaluate the Safety and Effectiveness of Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome (LINC7)

This is a multi-centre, observational, non-comparative, retrospective cohort study designed to evaluate the long-term safety and effectiveness of osilodrostat in non-CD CS patients. Patients treated with oral osilodrostat regardless of the duration of their treatment will be followed retrospectively for up to 36 months after initiating osilodrostat.

Conditions: Cushing's Syndrome
Being tested: Osilodrostat
Keywords: Endogenous Cushing's Syndrome, 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
oral administration

What is being measured

The primary outcome is the main question the study is designed to answer.

Effectiveness of Osilodrostat
Number and proportion of patients with Mean Urinary Free Cortisol (mUFC) ≤ upper limit of normal (ULN)
Measured: at week 12

Secondary outcomes (3)

Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC)
Proportion of patients with Mean Urinary Free Cortisol (mUFC) ≤ upper limit of normal (ULN) by visit until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.
Measured: at weeks 18, 24, 36, 48, 60, and 72
Long Term Effects of Osilodrostat on Morning Serum Cortisol
Proportion of patients with normal measures of morning serum cortisol [≤ upper normal limit (ULN)] by visit until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.
Measured: At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72
Long-term Effects of Osilodrostat on Composite Cortisol Measure
Proportion of patients with normal response of composite cortisol (salivary cortisol, urinary cortisol and morning serum cortisol) [≤ upper normal limit (ULN)] by visit until the earlier of loss to follow-up, treatment discontinuation, death and up to 36 months of retrospective follow-up.
Measured: At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Jan 202330 Oct 2023

First posted1 Dec 2022
Study start16 Jan 2023
Primary completion30 Sep 2023
Study completion30 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for 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: Retrospective
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05633953
Sponsor's protocol ID: LCI699-RECAG-NI-0596
Acronym: LINC7
Status last verified: Jan 2025
First submitted: 16 Nov 2022
Last updated: 10 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingPhase 1/2
Diagnostic Value of CXCR4-targeted PET/CT in ACTH-dependent and Independent Cushing's Syndrome
Cushing s Syndrome
RecruitingPhase 4
Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome
Hypertension, Hypercortisolemia
RecruitingObservational study
Collecting Information About Treatment Results for Patients With Cushing's Syndrome
Cushing's Disease, Cushing Syndrome

All Cushing's Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Retrospective Observational Study to Evaluate the Safety and Effectiveness of Osilodrostat for the Treatment of Non-Cushing's Disease Cushing's Syndrome (LINC7)
ClinicalTrials.gov ID: NCT05633953
Acronym / sponsor ID: LINC7 / LCI699-RECAG-NI-0596
Conditions: Cushing's Syndrome
Keywords: Endogenous Cushing's Syndrome, Cushing's Syndrome, Osilodrostat
Study type: Observational
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: RECORDATI GROUPIndustry (pharma, biotech, devices)
Study start: 16 Jan 2023 (actual)
Primary completion: 30 Sep 2023 (actual)
Study completion: 30 Oct 2023 (actual)
First posted: 1 Dec 2022 (actual)
Results: Posted 10 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Other
Time perspective: Retrospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The study population will consist of patients with non-CD CS. Patients meeting eligibility criteria will be retrospectively identified and included in the study by site investigators based on a review of medical records at site. Site policies and local regulations regarding patient consent (NOL) will be followed. All eligible patients identified at a site between April 2019 and study start date and consenting to be part of the study will be included.

Key inclusion criteria (2 listed)

Male and female patients ≥18 years old with diagnosis of CS, except for CD (i.e., an aetiology of adrenal adenoma, adrenocortical carcinoma, adrenal hyperplasia, or ectopic adrenocorticotropic hormone secretion). Patients should have a contemporaneously documented diagnosis of CS as per effective guidelines.
Patients treated with osilodrostat between April 2019 and study start date as part of ATU programme or commercialisation.

Key exclusion criteria (2 listed)

Patients who participated in a clinical trial anytime during the study period.
Patients with Pseudo-Cushing's syndrome, cyclic CS, or iatrogenic CS.

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
Osilodrostatoral administration	Drug	–

Primary outcome

Effectiveness of Osilodrostat
Time frame: at week 12
Number and proportion of patients with Mean Urinary Free Cortisol (mUFC) ≤ upper limit of normal (ULN)

3 secondary outcomes

Long-term Effects of Osilodrostat on Mean Urinary Free Cortisol (mUFC)
Time frame: at weeks 18, 24, 36, 48, 60, and 72
Long Term Effects of Osilodrostat on Morning Serum Cortisol
Time frame: At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72
Long-term Effects of Osilodrostat on Composite Cortisol Measure
Time frame: At baseline and Weeks 4, 8, 12, 18, 24, 36, 48, 60 and 72

Results and safety

Results posted to the registry on 10 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Osilodrostat	103	43

Primary outcome: Effectiveness of Osilodrostat

Time frame: at week 12. Count of participants. Unit: Participants

Measure	Osilodrostat_ITT n = 45
Value	23

Population analysed: Patients demonstrating a complete mUFC response at Week 12 with non-missing values

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: For 36 months (study period) and for at least 12 weeks of retrospective follow-up (follow-up for each patient was variable, and based on the clinical judgement of the physicians at the investigative sites).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Osilodrostat	52 of 103 (50.5%)	87 of 103 (84.5%)	30 of 103

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Cushing's Syndrome

Not yet recruitingPhase 2
Osilodrostat for Glycemic Control in Mild Autonomous Cortisol Secretion (MACS) With Difficult-To-Control Type 2 Diabetes - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study
Mild Autonomous Cortisol Secretion (MACS), Diabetes Mellitus (Type 2)
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingPhase 1/2
Diagnostic Value of CXCR4-targeted PET/CT in ACTH-dependent and Independent Cushing's Syndrome
Cushing s Syndrome
RecruitingPhase 4
Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome
Hypertension, Hypercortisolemia
RecruitingObservational study
Collecting Information About Treatment Results for Patients With Cushing's Syndrome
Cushing's Disease, Cushing Syndrome

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 M MALDONADO, MD study director

RECORDATI GROUP

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 Cushing's Syndrome, run by RECORDATI GROUP at 1 site in France.

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 2 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 10 Feb 2025. 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 France. 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?

Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Effectiveness of Osilodrostat (time frame: at week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05633953.

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 10 Feb 2025.