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SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor (ACSPIRE)

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ClinicalTrials.gov Identifier: NCT05436639
Recruitment Status : Recruiting
First Posted : June 29, 2022
Last Update Posted : April 19, 2024
Sponsor:
Information provided by (Responsible Party):
Sparrow Pharmaceuticals

Study Description
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Brief Summary:
This will be a 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.

Condition or disease Intervention/treatment Phase
Autonomous Cortisol Secretion (ACS) ACTH-Independent Cushing Syndrome ACTH-Independent Adrenal Cushing Syndrome, Somatic Drug: SPI-62 dose1 Drug: SPI-62 dose 2 Drug: SPI-62 dose 3 Drug: SPI-62 dose 4 Drug: Placebo Phase 2

Detailed Description:
This is a multicenter, 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
Actual Study Start Date : July 1, 2023
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : December 1, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SPI-62 dose 1
0.2mg dose level of SPI-62. Active drug by mouth each morning for up to 12 weeks.
 Drug: SPI-62 dose1
SPI-62 is an 11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, supplied as oral tablets for dose 1 of drug (0.2mg).
Experimental: SPI-62 dose 2
0.6mg dose level of SPI-62. Active drug by mouth each morning for up to 12 weeks.
 Drug: SPI-62 dose 2
SPI-62 is an 11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, supplied as oral tablets for dose 2 of drug (0.6mg).
Experimental: SPI-62 dose 3
2mg dose level of SPI-62. Active drug by mouth each morning for up to 12 weeks.
 Drug: SPI-62 dose 3
SPI-62 is an 11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, supplied as oral tablets for dose 2 of drug (2mg).
Experimental: SPI-62 dose 4
6mg dose level of SPI-62. Active drug by mouth each morning for up to 12 weeks.
 Drug: SPI-62 dose 4
SPI-62 is an 11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, supplied as oral tablets for dose 2 of drug (6mg).
Placebo Comparator: Placebo
Placebo by mouth each morning for up to 12 weeks.
 Drug: Placebo
Inactive tablets identical to SPI-62 tablets.


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c at Week 6 [ Time Frame: Baseline to week 6 ]
    HbA1c change from baseline

  2. Change in HbA1c at week 12 [ Time Frame: Baseline to week 12 ]
    HbA1c change from baseline


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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%
    • 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.

Exclusion Criteria:

  • 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).
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05436639


Contacts
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Contact: Frank Czerwiec, MD +1-617-465-0328 fczerwiec@sparrowpharma.com
Contact: Sarah Hooper +1-617-465-0328 shooper@sparrowpharma.com

Locations
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Sponsors and Collaborators
Sparrow Pharmaceuticals
Investigators
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Study Chair: Frank Czerwiec, MD Sparrow Pharmaceuticals
More Information
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Responsible Party: Sparrow Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05436639    
Other Study ID Numbers: SPI-62-CL-2002
First Posted: June 29, 2022    Key Record Dates
Last Update Posted: April 19, 2024
Last Verified: April 2024

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sparrow Pharmaceuticals:
Autonomous Cortisol secretion (ACS)
ACTH-independent adrenal Cushing's syndrome (aCs)
benign adrenal tumor
Additional relevant MeSH terms:
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Adrenal Gland Neoplasms
Cushing Syndrome
Adrenocortical Hyperfunction
Syndrome
Disease
Pathologic Processes
 Adrenal Gland Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms