HypertensionPhase 4LINC CARENCT07247162
Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome
A Phase 4 study testing Osilodrostat in people with Hypertension and Hypercortisolemia, run by RECORDATI GROUP at 3 sites in United States.
Trial summary
Osilodrostat has proven to be a safe and efficacious treatment for patients with CS. Demonstrating normalisation of hypercortisolaemia and in patients with hypertension and/or dysglycaemia clinically relevant and statistically significant reductions in blood pressure and glycaemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension, Hypercortisolemia, Cushing Syndrome
- What is being tested?
- Osilodrostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Aug 2026to Jul 2028
- Phase
- Phase 4
- 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
Who may be able to join
- Male or female ≥ 18 years of age
- Able to provide and have provided signed written informed consent prior to study participation
- Diagnosis of endogenous Cushing's Syndrome
- mUFC values from two 24h urinary collections > ULN and ≤ 2x ULN
- Participants with uncontrolled hypertension on stable doses of BP lowering medications (for at least 4 weeks); qualifying BP measurements by ABPM taken prior to randomisation defined as: Average of 24h ABPM SBP ≥ 135 or DBP ≥ 85 mmHg
- Participants under glucocorticoid replacement therapy can be recruited only if this therapy has been already stopped for at least seven days or 5 half-lives prior to screening, whichever was longer
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- Not taking any drug therapy for CS. The following minimum periods without these medications need to be completed before baseline assessments:
- Steroidogenesis inhibitors (e.g. ketoconazole, metyrapone): 1 week
- Mifepristone: 3 weeks
- SC Pasireotide: 1 week
- Pasireotide LAR: 3 months
- Cabergoline: 4 weeks
- Able to take oral medication and be willing to comply with the requirements of the study
Who cannot join
- Previously treated with osilodrostat less than 12 weeks prior to start of screening
- Known hypersensitivity to osilodrostat
- Presence of any severe and/or uncontrolled medical condition or other conditions that could affect participation in the study
- Participants who are scheduled for a surgery to treat CS within 32 weeks of randomisation to the study drug
- Presence of a known "long term" history of both hypertension and diabetes (defined as both hypertension and diabetes diagnosed >10 years prior to the initial diagnosis of endogenous CS)
- History of cyclic CS with fluctuating clinical manifestations
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- Participants with pseudo-CS
- Participants with compression of the optic chiasm due to a macroadenoma or participants at high risk of compression of the optic chiasm (tumour within 2 mm of optic chiasm)
- Participants who have undergone pituitary or adrenal surgery for Cushing's syndrome within 3 months prior to screening.
- Pituitary radiation therapy within 3 years of screening
- Ectopic ACTH syndrome or adrenocortical carcinoma with a life expectancy of <3 years or receiving chemotherapy
- Having received prior mitotane treatment
- Participants who are shift workers or have conditions that can affect the measurement of late-night salivary cortisol (LNSC) or the LDDST
- Poorly controlled diabetes mellitus with a baseline HbA1c > 10.5%. Participants receiving glucose lowering medications must be on stable doses for at least 4 weeks prior screening.
- Participants who are hypothyroid and not on adequate replacement therapy
- History of major surgery/surgical therapy for any cause within 4 weeks before entering the study. Participants should have recovered from the surgery and be in good clinical condition before entering the study
- Presence of bradycardia and/or QT-related exclusion criteria
- Total bilirubin > 1.5 x ULN and ALT or AST > 3 x ULN
- Participation in any clinical investigation within 4 weeks prior to screening or longer if required by local regulation (Use of an investigational drug within 4 weeks prior to dosing)
- Occurrence of any significant acute illness within 3 weeks prior to dosing/randomisation
- Female participants who are pregnant, intending to become pregnant or breastfeed during the study or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- Women of childbearing potential (WOCBP) who are unwilling to use highly effective contraception methods
- Potentially unreliable or vulnerable participants (e.g. person kept in detention) and those judged by the Investigator to be unsuitable for the study.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Diabetes And Endocrinology Associates Of Stark County, Inc.
Canton, Ohio, 44718
Rachel Bledsoe, 330-493-0013 ext. 129, rachelb@go2endo.com
- Recruiting
NOLA Care, LLC
Jacksonville, Florida, 32258
Rosina Ducote, 904-701-3610, rosinaducote@gmail.com
- Recruiting
Texas Valley Clinical Research
Weslaco, Texas, 78596
Anna Rubio Rodriguez, 956-554-4003, annar@tvcrtrials.com
About this study
Official title: A Double-blind, Randomised, 30-week Placebo-controlled Phase IV Study to Assess the Efficacy and Safety of Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome
Osilodrostat has proven to be a safe and efficacious treatment for patients with CS. Demonstrating normalisation of hypercortisolaemia and in patients with hypertension and/or dysglycaemia clinically relevant and statistically significant reductions in blood pressure and glycaemia. This study aims at providing additional evidence on the safety, efficacy and appropriate dosing of osilodrostat in patients with CS, who have hypertension.
- Conditions
- Hypertension, Hypercortisolemia, Cushing Syndrome
- Being tested
- Osilodrostat, Placebo
- Keywords
- osilodrostat, hypertension, hypercolesterolaemia, cushing's syndrome
- Medical subject headings
- Hypertension, ACTH Syndrome, Ectopic, 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
Osilodrostat tablets 1 mg and 5 mg for oral useOsilodrostat tablets 1 mg and 5 mg for oral use.During the 18-week titration phase, the dose of the medication will be titrated every 3 weeks based on the cortisolaemic and clinical response to treatment. An independent endocrinologist titration committee will be applied to provide recommendations on dose-titration based on biochemical and clinical response. At the end of the 18-week dose titration phase, participants will enter a 12-week dose maintenance phase, which is also blinded. They will continue with the dose they were receiving at the end of the dose titration phase, unless there is a need to down-titrate or to stop the study medication for safety purposes.
PlaceboDrug
matching placebo
| Study group | Role | What they receive |
|---|---|---|
| LCI699 (osilodrostat) | Experimental | 1 mg QOD Receives: Drug: Osilodrostat |
| Placebo | Placebo comparator | matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the efficacy of osilodrostat on the proportion of participants with normalization of urinary-free cortisol (UFC)
Normalization status for each participant at Week 30 of treatment with osilodrostat or placebo, based on the mean of UFC concentrations from two 24-hour urine collections, with normalization defined as ≤1× the upper limit of normal (ULN).
Measured: 30 weeks
Secondary outcomes (37)
Percentage of Participants With Blood Pressure Response by 24-Hour Ambulatory Blood Pressure Monitoring (ABPM) at Week 30 (key secondary)
Blood pressure (BP) responder status is assessed by 24-hour ABPM. This measure will check the % of participants that are responders. A participant is a responder if mean systolic and/or diastolic BP decreases by at least 5 mmHg from baseline, without worsening of either and without any modification in antihypertensive medication attributable to worsening hypertension. Participants without a valid ABPM assessment at Week 30 are classified as non-responders.
Measured: Week 30
Percentage of Participants With Hypocortisolism-Related Adverse Events (Overall)
Percentage of participants with at least one hypocortisolism-related adverse event (AE) during the treatment period.
Measured: Week 30
Percentage of Participants With Glucocorticoid Withdrawal Syndrome
Percentage of participants with glucocorticoid withdrawal syndrome, a category of hypocortisolism-related AEs, during the treatment period.
Measured: Week 30
Percentage of Participants With Confirmed Adrenal Insufficiency
Percentage of participants with confirmed adrenal insufficiency, a category of hypocortisolism-related AEs, during the treatment period.
Measured: Week 30
Percentage of Participants With Glycemic Response at Week 30 in Participants With High-Risk Dysglycemia
Assessed in participants with high-risk dysglycemia at baseline (HbA1c >=6.0%). A glycemic responder has a reduction of at least 25% from baseline in glucose area under the curve (AUC) during an oral glucose tolerance test (OGTT), without the addition of, or an increase in the dose of, glucose-lowering medications.
Measured: baseline and Week 30
Percentage of Participants With Glycemic Response at Week 21 in Participants With High-Risk Dysglycemia
Assessed in participants with high-risk dysglycemia at baseline (HbA1c >=6.0%). A glycemic responder has a reduction of at least 25% from baseline in glucose area under the curve (AUC) during an oral glucose tolerance test (OGTT), without the addition of, or an increase in the dose of, glucose-lowering medications.
Measured: Baseline and Week 21
Percentage of Participants With Body Weight Response at Week 30
A body weight responder has a decrease of at least 5% from baseline in body weight, without the addition of, or an increase in the dose of, weight-lowering medications.
Measured: baseline and Week 30
Percentage of Participants With Body Weight Response at Week 21
A body weight responder has a decrease of at least 5% from baseline in body weight, without the addition of, or an increase in the dose of, weight-lowering medications.
Measured: baseline and Week 21
Change From Baseline in Systolic Blood Pressure (SBP) by 24-Hour ABPM at Week 30
Change from baseline in mean 24-hour SBP measured by ambulatory blood pressure monitoring (ABPM). Change = value at Week 30 minus baseline value.
Measured: Baseline, Week 30
Change From Baseline in Systolic Blood Pressure (SBP) by 24-Hour ABPM at Week 21
Change from baseline in mean 24-hour SBP measured by ambulatory blood pressure monitoring (ABPM). Change = value at Week 21 minus baseline value.
Measured: baseline and Week 21
Change From Baseline in Glucose AUC During OGTT at Week 30 in Participants With High-Risk Dysglycemia
Assessed in participants with high-risk dysglycemia at baseline (HbA1c >=6.0%). Change from baseline in glucose area under the curve (AUC) during an oral glucose tolerance test (OGTT). Change = value at Week 30 minus baseline value.
Measured: baseline and Week 30
Change From Baseline in Glucose AUC During OGTT at Week 21 in Participants With High-Risk Dysglycemia
Assessed in participants with high-risk dysglycemia at baseline (HbA1c >=6.0%). Change from baseline in glucose area under the curve (AUC) during an oral glucose tolerance test (OGTT). Change = value at Week 21 minus baseline value.
Measured: baseline and Week 21
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 30 in Participants With High-Risk Dysglycemia
Assessed in participants with high-risk dysglycemia at baseline (HbA1c >=6.0%). Change = HbA1c value at Week 30 minus baseline value.
Measured: baseline and Week 30
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 21 in Participants With High-Risk Dysglycemia
Assessed in participants with high-risk dysglycemia at baseline (HbA1c >=6.0%). Change = HbA1c value at Week 21 minus baseline value.
Measured: baseline and Week 21
Change From Baseline in 2-Hour Postprandial Glucose at Week 30 in Participants With High-Risk Dysglycemia
Assessed in participants with high-risk dysglycemia at baseline (HbA1c >=6.0%). Change = 2-hour postprandial glucose value at Week 30 minus baseline value.
Measured: Baseline, Week 30
Change From Baseline in 2-Hour Postprandial Glucose at Week 21 in Participants With High-Risk Dysglycemia
Assessed in participants with high-risk dysglycemia at baseline (HbA1c >=6.0%). Change = 2-hour postprandial glucose value at Week 21 minus baseline value.
Measured: baseline and Week 21
Change From Baseline in Fasting Plasma Glucose Over Time in Participants With High-Risk Dysglycemia
Assessed in participants with high-risk dysglycemia at baseline (HbA1c >=6.0%). Change from baseline in fasting plasma glucose (FPG) at each scheduled visit.
Measured: Up to Week 30
Change From Baseline in Body Weight Over Time
Change from baseline in body weight at each scheduled visit.
Measured: Up to Week 30
Participants (n) With Adverse Events
Frequency of participants with AEs, by treatment group, during the treatment period.
Measured: Up to Week 30
Participants (%) With Adverse Events
percentage of participants with AEs, by treatment group, during the treatment period.
Measured: Up to Week 30
Change From Baseline in Laboratory Values
Change from baseline in safety laboratory values at each scheduled visit.
Measured: Up to Week 30
Change From Baseline in Electrocardiogram (ECG) Parameters
Change from baseline in ECG readings at each scheduled visit.
Measured: Up to Week 30
Change From Baseline in Vital Signs
Change from baseline in vital signs at each scheduled visit.
Measured: Up to Week 30
Shift in American Heart Association (AHA) Hypertension Category From Baseline to Week 30
Distribution of participants by AHA blood pressure classification category at Week 30 compared with baseline.
Measured: baseline and Week 30
Shift in American Heart Association (AHA) Hypertension Category From Baseline to Week 21
Distribution of participants by AHA blood pressure classification category at Week 21 compared with baseline.
Measured: baseline and Week 21
Shift in American Diabetes Association (ADA) Glycemia Category From Baseline to Week 30
Distribution of participants by ADA glycemia classification category at Week 30 compared with baseline.
Measured: baseline and Week 30
Shift in American Diabetes Association (ADA) Glycemia Category From Baseline to Week 21
Distribution of participants by ADA glycemia classification category at Week 21 compared with baseline.
Measured: baseline and Week 21
Change From Baseline in Blood Pressure-Lowering Medications (Dose Changes) at Week 30
Distribution of dose changes (increase, decrease, no change) of blood pressure-lowering medications at Week 30 compared with baseline.
Measured: baseline and Week 30
Change From Baseline in Blood Pressure-Lowering Medications (Number) at Week 30
number of blood pressure-lowering medications at Week 30 compared with baseline.
Measured: baseline and Week 30
Change From Baseline in Blood Pressure-Lowering Medications (Number) at Week 21
number of blood pressure-lowering medications at Week 21 compared with baseline.
Measured: baseline and Week 21
Change From Baseline in Blood Pressure-Lowering Medications (Dose Change) at Week 21
Distribution of dose changes (increase, decrease, no change) of blood pressure-lowering medications at Week 21 compared with baseline.
Measured: baseline and Week 21
Change From Baseline in Glucose-Lowering Medications (Dose Changes) at Week 30
Distribution of dose changes (increase, decrease, no change) of glucose-lowering medications at Week 30 compared with baseline.
Measured: baseline and Week 30
Change From Baseline in Glucose-Lowering Medications (Dose Changes) at Week 21
Distribution of dose changes (increase, decrease, no change) of glucose-lowering medications at Week 21 compared with baseline.
Measured: Baseline, Week 21
Change From Baseline in Glucose-Lowering Medications (Number) at Week 30
number of glucose-lowering medications at Week 30 compared with baseline.
Measured: Baseline, Week 30
Change From Baseline in Glucose-Lowering Medications (Number) at Week 21
number of glucose-lowering medications at Week 21 compared with baseline.
Measured: baseline and Week 21
Percentage of Participants With Normalization of 24-Hour Urinary Free Cortisol (UFC) Over Time
Normalization status of 24-hour UFC for each participant at each scheduled visit, defined as UFC <=1x the upper limit of normal (ULN).
Measured: up Week 30
Percentage of Participants With Blood Pressure Response by 24-Hour ABPM at Week 21
Blood pressure (BP) responder status is assessed by 24-hour ABPM. A participant is a responder if mean systolic and/or diastolic BP decreases by at least 5 mmHg from baseline, without worsening of either and without any modification in antihypertensive medication attributable to worsening hypertension.
Measured: Week 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2025
- Study start26 Aug 2026
- Primary completionMay 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 63 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RECORDATI GROUP
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Irina Bancos, MD, Study chair, Mayo Clinic (Rochester, Minnesota , US)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07247162
- Sponsor's protocol ID
- LCI699-RECAG-CL-0615
- Other IDs
- 2025-524649-28-00, 2025
- Acronym
- LINC CARE
- Status last verified
- Oct 2026
- First submitted
- 19 Nov 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, 30-week Placebo-controlled Phase IV Study to Assess the Efficacy and Safety of Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome
- ClinicalTrials.gov ID
- NCT07247162
- Acronym / sponsor ID
- LINC CARE / LCI699-RECAG-CL-0615
- Conditions
- Hypertension, Hypercortisolemia, Cushing Syndrome
- Keywords
- osilodrostat, hypertension, hypercolesterolaemia, cushing's syndrome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 63 participants (estimated)
- Lead sponsor
- RECORDATI GROUPIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2026 (actual)
- Primary completion
- May 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 25 Nov 2025 (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.
Osilodrostat has proven to be a safe and efficacious treatment for patients with CS. Demonstrating normalisation of hypercortisolaemia and in patients with hypertension and/or dysglycaemia clinically relevant and statistically significant reductions in blood pressure and glycaemia. This study aims at providing additional evidence on the safety, efficacy and appropriate dosing of osilodrostat in patients with CS, who have hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LCI699 (osilodrostat) | Experimental | Drug: Osilodrostat1 mg QOD |
| Placebo | Placebo comparator | Drug: Placebomatching placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Male or female ≥ 18 years of age
- Able to provide and have provided signed written informed consent prior to study participation
- Diagnosis of endogenous Cushing's Syndrome
- mUFC values from two 24h urinary collections > ULN and ≤ 2x ULN
- Participants with uncontrolled hypertension on stable doses of BP lowering medications (for at least 4 weeks); qualifying BP measurements by ABPM taken prior to randomisation defined as: Average of 24h ABPM SBP ≥ 135 or DBP ≥ 85 mmHg
Key exclusion criteria (23 listed)
- Previously treated with osilodrostat less than 12 weeks prior to start of screening
- Known hypersensitivity to osilodrostat
- Presence of any severe and/or uncontrolled medical condition or other conditions that could affect participation in the study
- Participants who are scheduled for a surgery to treat CS within 32 weeks of randomisation to the study drug
- Presence of a known "long term" history of both hypertension and diabetes (defined as both hypertension and diabetes diagnosed >10 years prior to the initial diagnosis of endogenous 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 |
|---|---|---|
| OsilodrostatAlso: isturisaOsilodrostat tablets 1 mg and 5 mg for oral useOsilodrostat tablets 1 mg and 5 mg for oral use.During the 18-week titration phase, the dose of the medication will be titrated every 3 weeks based on the cortisolaemic and clinical response to treatment. An independent endocrinologist titration committee will be applied to provide recommendations on dose-titration based on biochemical and clinical response. At the end of the 18-week dose titration phase, participants will enter a 12-week dose maintenance phase, which is also blinded. They will continue with the dose they were receiving at the end of the dose titration phase, unless there is a need to down-titrate or to stop the study medication for safety purposes. | Drug | LCI699 (osilodrostat) |
| Placebomatching placebo | Drug | Placebo |
Primary outcome
To evaluate the efficacy of osilodrostat on the proportion of participants with normalization of urinary-free cortisol (UFC)
Time frame: 30 weeks
Normalization status for each participant at Week 30 of treatment with osilodrostat or placebo, based on the mean of UFC concentrations from two 24-hour urine collections, with normalization defined as ≤1× the upper limit of normal (ULN).
37 secondary outcomes
Percentage of Participants With Blood Pressure Response by 24-Hour Ambulatory Blood Pressure Monitoring (ABPM) at Week 30 (key secondary)
Time frame: Week 30
Percentage of Participants With Hypocortisolism-Related Adverse Events (Overall)
Time frame: Week 30
Percentage of Participants With Glucocorticoid Withdrawal Syndrome
Time frame: Week 30
Percentage of Participants With Confirmed Adrenal Insufficiency
Time frame: Week 30
Percentage of Participants With Glycemic Response at Week 30 in Participants With High-Risk Dysglycemia
Time frame: baseline and Week 30
Percentage of Participants With Glycemic Response at Week 21 in Participants With High-Risk Dysglycemia
Time frame: Baseline and Week 21
Percentage of Participants With Body Weight Response at Week 30
Time frame: baseline and Week 30
Percentage of Participants With Body Weight Response at Week 21
Time frame: baseline and Week 21
Change From Baseline in Systolic Blood Pressure (SBP) by 24-Hour ABPM at Week 30
Time frame: Baseline, Week 30
Change From Baseline in Systolic Blood Pressure (SBP) by 24-Hour ABPM at Week 21
Time frame: baseline and Week 21
Change From Baseline in Glucose AUC During OGTT at Week 30 in Participants With High-Risk Dysglycemia
Time frame: baseline and Week 30
Change From Baseline in Glucose AUC During OGTT at Week 21 in Participants With High-Risk Dysglycemia
Time frame: baseline and Week 21
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 30 in Participants With High-Risk Dysglycemia
Time frame: baseline and Week 30
Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 21 in Participants With High-Risk Dysglycemia
Time frame: baseline and Week 21
Change From Baseline in 2-Hour Postprandial Glucose at Week 30 in Participants With High-Risk Dysglycemia
Time frame: Baseline, Week 30
Change From Baseline in 2-Hour Postprandial Glucose at Week 21 in Participants With High-Risk Dysglycemia
Time frame: baseline and Week 21
Change From Baseline in Fasting Plasma Glucose Over Time in Participants With High-Risk Dysglycemia
Time frame: Up to Week 30
Change From Baseline in Body Weight Over Time
Time frame: Up to Week 30
Participants (n) With Adverse Events
Time frame: Up to Week 30
Participants (%) With Adverse Events
Time frame: Up to Week 30
Change From Baseline in Laboratory Values
Time frame: Up to Week 30
Change From Baseline in Electrocardiogram (ECG) Parameters
Time frame: Up to Week 30
Change From Baseline in Vital Signs
Time frame: Up to Week 30
Shift in American Heart Association (AHA) Hypertension Category From Baseline to Week 30
Time frame: baseline and Week 30
Shift in American Heart Association (AHA) Hypertension Category From Baseline to Week 21
Time frame: baseline and Week 21
Shift in American Diabetes Association (ADA) Glycemia Category From Baseline to Week 30
Time frame: baseline and Week 30
Shift in American Diabetes Association (ADA) Glycemia Category From Baseline to Week 21
Time frame: baseline and Week 21
Change From Baseline in Blood Pressure-Lowering Medications (Dose Changes) at Week 30
Time frame: baseline and Week 30
Change From Baseline in Blood Pressure-Lowering Medications (Number) at Week 30
Time frame: baseline and Week 30
Change From Baseline in Blood Pressure-Lowering Medications (Number) at Week 21
Time frame: baseline and Week 21
Change From Baseline in Blood Pressure-Lowering Medications (Dose Change) at Week 21
Time frame: baseline and Week 21
Change From Baseline in Glucose-Lowering Medications (Dose Changes) at Week 30
Time frame: baseline and Week 30
Change From Baseline in Glucose-Lowering Medications (Dose Changes) at Week 21
Time frame: Baseline, Week 21
Change From Baseline in Glucose-Lowering Medications (Number) at Week 30
Time frame: Baseline, Week 30
Change From Baseline in Glucose-Lowering Medications (Number) at Week 21
Time frame: baseline and Week 21
Percentage of Participants With Normalization of 24-Hour Urinary Free Cortisol (UFC) Over Time
Time frame: up Week 30
Percentage of Participants With Blood Pressure Response by 24-Hour ABPM at Week 21
Time frame: Week 21
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 2 Nov 2026.
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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.
Irina Bancos, MD study chair
Mayo Clinic (Rochester, Minnesota , US)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Osilodrostat in people with Hypertension and Hypercortisolemia, run by RECORDATI GROUP at 3 sites in United States.
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 13 inclusion and 23 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: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Michal Sarnecki (+41 (0)79 911 79 87, sarnecki.m@recordati.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the efficacy of osilodrostat on the proportion of participants with normalization of urinary-free cortisol (UFC) (time frame: 30 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 2 Nov 2026.