Autonomous Cortisol Secretion (ACS)Phase 2ACSPIRENCT05436639
SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
A Phase 2 study testing SPI-62 dose in people with Autonomous Cortisol Secretion (ACS) and ACTH-Independent Cushing Syndrome, run by Sparrow Pharmaceuticals at 5 sites in 3 countries.
Trial summary
This is study with SPI-62 to evaluate the efficacy, safety, and pharmacological effect of SPI-62 in subjects with hypercortisolism related to a benign adrenal tumor. Each subject will receive 2mg of SPI-62 daily. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Autonomous Cortisol Secretion (ACS), ACTH-Independent Cushing Syndrome, ACTH-Independent Adrenal Cushing Syndrome, Somatic
- What is being tested?
- SPI-62 dose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesin 3 countries
- Study dates
- 1 Jul 2023to 18 Feb 2025
- Phase
- Phase 2
- 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
Who may be able to join
- Diagnosis and main criteria for inclusion and exclusion:
- The following are the main inclusion criteria:
- Adults able to provide informed consent.
- Documented characteristically benign adrenal nodule, with diameter ≤ 4 cm, homogenous texture, and non-contrast computerized tomography ≤ 20 HU attenuation or proven to be non malignant.
- Diagnosis of diabetes mellitus, pre-diabetes or impaired glucose tolerance, either untreated or on stable standard of care treatment, based on at least one of:
- HbA1c ≥ 5.7% but not > 9.5%
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- 2-hour glucose level ≥ 7.8 mmol (140 mg/dL) on a 75 g OGTT
- At least one additional documented cortisol-related morbidities, either untreated or on stable standard of care treatment:
- hypercholesterolemia with total cholesterol > 3.9 mM (150 mg/dL);
- hypertriglyceridemia with triglycerides > 2.3 mM (200 mg/dL);
- osteopenia with bone densitometry Z-score < -2.0 or T-score < -1.0;
- history or evidence of minimally traumatic or osteoporotic fracture; or
- hypertension with resting supine blood pressure > 130 but < 180 mmHg systolic or > 85 but < 120 mmHg diastolic.
- Poorly suppressible hypercortisolemia:
- Morning serum cortisol > 50 nM (1.8 mcg/dL) after a 1 mg ONDST.
- Subjects with dexamethasone < 3.3 nmol/L (130 ng/dL) will undergo a high-dose (8 mg) ONDST.
- Subjects who take estrogen-containing medicines will be evaluated based on free cortisol > 2.2 nM (80 ng/dL).
- For subjects with morning serum cortisol > 138 nM (5.0 mcg/dL) after ONDST, the Investigator will assess for adrenal Cushing's syndrome.
Who cannot join
- Diagnosis of ACTH-dependent Cushing's syndrome, pheochromocytoma, aldosteronoma, adrenocortical carcinoma, or congenital adrenal hyperplasia, or other malignancy associated hypercortisolism including history of adrenal carcinoma.
- History of adrenalectomy or planned adrenalectomy within 4 months after randomization.
- Exogenous hypercortisolism.
- Uncontrolled, clinically significant hypo- or hyperthyroidism.
- History of idiopathic thrombocytopenia.
- Moderately impaired renal function (estimated glomerular filtration rate < 60 mL/min/1.73m2).
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- History of cancer (other than non-melanoma skin, thyroid, or early-stage prostate cancer) within 3 years.
- Any major surgery, or significant post-operative sequelae, within 1 month prior to informed consent or planned during the trial.
- Pregnant or lactating.
- Positive test for severe acute respiratory syndrome coronavirus 2 infection within 4 weeks, or hospitalization for Coronavirus disease 2019 within 6 months, prior to randomization.
- Any other current or prior medical condition expected to interfere with the conduct of the trial or the evaluation of its results.
- Participation in any clinical trial within 3 months prior to the first dose of study drug, or longer depending on half-life of the investigational therapy.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
United States2 sites
Ohio State McCampbell Outpatient Care
Columbus, Ohio, 43210
Mayo Clinic Cancer Center (MCCC) - Rochester
Rochester, Minnesota, 55905
Romania2 sites
C.M.D.T.A. Neomed
Brasov, 500283
Institutul National de Endocrinologie
Bucharest, 11863
About this study
This is study with SPI-62 to evaluate the efficacy, safety, and pharmacological effect of SPI-62 in subjects with hypercortisolism related to a benign adrenal tumor. Each subject will receive 2mg of SPI-62 daily.
Read the detailed description
This is a multicenter, open-label, single-arm study, Phase 2 study to estimate SPI-62's effect on clinical features of hypercortisolism related to a benign adrenal tumor, including diabetes/impaired glucose tolerance, hyperlipidemia, hypertension, and osteopenia. Each subject who provides consent and meets all inclusion and exclusion criteria will participate in a screening period and an open-ended treatment period. Visits occur at screening/baseline, months 1, 3, 6, 9, and 12, and then quarter-annually.
- Conditions
- Autonomous Cortisol Secretion (ACS), ACTH-Independent Cushing Syndrome, ACTH-Independent Adrenal Cushing Syndrome, Somatic
- Being tested
- SPI-62 dose
- Keywords
- Autonomous Cortisol secretion (ACS), ACTH-independent adrenal Cushing's syndrome (aCs), benign adrenal tumor
- Medical subject headings
- Acth-Independent Macronodular Adrenal Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPI-62 doseDrug
SPI-62 is an 11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, supplied as oral tablets for dose 2 of drug (2mg).
| Study group | Role | What they receive |
|---|---|---|
| SPI-62 dose | Experimental | 2mg dose level of SPI-62. Active drug by mouth. Receives: Drug: SPI-62 dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c at Week 6
HbA1c change from baseline
Measured: Baseline to week 6
Change in HbA1c at week 12
HbA1c change from baseline
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Jul 2023
- Primary completion1 Dec 2024
- Study completion18 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autonomous Cortisol Secretion (ACS)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sparrow Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frank Czerwiec, MD, Study chair, Sparrow Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05436639
- Sponsor's protocol ID
- SPI-62-CL-2002
- Acronym
- ACSPIRE
- Status last verified
- May 2024
- First submitted
- 23 Jun 2022
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
- ClinicalTrials.gov ID
- NCT05436639
- Acronym / sponsor ID
- ACSPIRE / SPI-62-CL-2002
- Conditions
- Autonomous Cortisol Secretion (ACS), ACTH-Independent Cushing Syndrome, ACTH-Independent Adrenal Cushing Syndrome, Somatic
- Keywords
- Autonomous Cortisol secretion (ACS), ACTH-independent adrenal Cushing's syndrome (aCs), benign adrenal tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sparrow PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 29 Jun 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 study with SPI-62 to evaluate the efficacy, safety, and pharmacological effect of SPI-62 in subjects with hypercortisolism related to a benign adrenal tumor. Each subject will receive 2mg of SPI-62 daily.
Detailed description
This is a multicenter, open-label, single-arm study, Phase 2 study to estimate SPI-62's effect on clinical features of hypercortisolism related to a benign adrenal tumor, including diabetes/impaired glucose tolerance, hyperlipidemia, hypertension, and osteopenia. Each subject who provides consent and meets all inclusion and exclusion criteria will participate in a screening period and an open-ended treatment period. Visits occur at screening/baseline, months 1, 3, 6, 9, and 12, and then quarter-annually.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPI-62 dose | Experimental | Drug: SPI-62 dose2mg dose level of SPI-62. Active drug by mouth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Adults able to provide informed consent.
- Documented characteristically benign adrenal nodule, with diameter ≤ 4 cm, homogenous texture, and non-contrast computerized tomography ≤ 20 HU attenuation or proven to be non malignant.
- Diagnosis of diabetes mellitus, pre-diabetes or impaired glucose tolerance, either untreated or on stable standard of care treatment, based on at least one of:
- At least one additional documented cortisol-related morbidities, either untreated or on stable standard of care treatment:
- Poorly suppressible hypercortisolemia:
Key exclusion criteria (12 listed)
- Diagnosis of ACTH-dependent Cushing's syndrome, pheochromocytoma, aldosteronoma, adrenocortical carcinoma, or congenital adrenal hyperplasia, or other malignancy associated hypercortisolism including history of adrenal carcinoma.
- History of adrenalectomy or planned adrenalectomy within 4 months after randomization.
- Exogenous hypercortisolism.
- Uncontrolled, clinically significant hypo- or hyperthyroidism.
- History of idiopathic thrombocytopenia.
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 |
|---|---|---|
| SPI-62 doseSPI-62 is an 11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, supplied as oral tablets for dose 2 of drug (2mg). | Drug | SPI-62 dose |
Primary outcome
Change in HbA1c at Week 6
Time frame: Baseline to week 6
HbA1c change from baseline
Change in HbA1c at week 12
Time frame: Baseline to week 12
HbA1c change from baseline
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 13 Feb 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. This study is not recruiting at the moment.
Frank Czerwiec, MD study chair
Sparrow Pharmaceuticals
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SPI-62 dose in people with Autonomous Cortisol Secretion (ACS) and ACTH-Independent Cushing Syndrome, run by Sparrow Pharmaceuticals at 5 sites in 3 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 18 inclusion and 12 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 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Romania, United Kingdom. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in HbA1c at Week 6 (time frame: Baseline to week 6). The study lists 2 primary outcomes in all. 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 13 Feb 2026.