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

NCT05436639 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: SPI-62-CL-2002
• Study Type: interventional
• Target: 30
• Locations: 3 countries
• Sites: 5

Brief 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.

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

Outcome Measures

Primary Outcomes (2)

• Change in HbA1c at Week 6

  HbA1c change from baseline

  Baseline to week 6

• Change in HbA1c at week 12

  HbA1c change from baseline

  Baseline to week 12

Study Arms (1)

SPI-62 dose

EXPERIMENTAL

2mg dose level of SPI-62. Active drug by mouth.

Drug: SPI-62 dose

Interventions

SPI-62 dose DRUG

SPI-62 is an 11β hydroxysteroid dehydrogenase type 1 (HSD-1) inhibitor, supplied as oral tablets for dose 2 of drug (2mg).

SPI-62 dose

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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%
• 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).

Sponsors & Collaborators

• Sparrow Pharmaceuticals: lead

Study Sites (5)

Mayo Clinic Cancer Center (MCCC) - Rochester

Rochester, Minnesota, 55905, United States

Location

Ohio State McCampbell Outpatient Care

Columbus, Ohio, 43210, United States

Location

C.M.D.T.A. Neomed

Brasov, 500283, Romania

Location

Institutul National de Endocrinologie

Bucharest, 11863, Romania

Location

King's College Hospital

London, SW9 8RR, United Kingdom

Location

MeSH Terms

Conditions

Acth-Independent Macronodular Adrenal Hyperplasia

Study Officials

• Frank Czerwiec, MD

  Sparrow Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 29, 2022
• Study Start: July 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: February 18, 2025
• Last Updated: February 13, 2026

Record last verified: 2024-05

Locations

US (2); GB (1); RO (2)