---
title: SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
nct_id: NCT05436639
overall_status: COMPLETED
phase: PHASE2
sponsor: Sparrow Pharmaceuticals
study_type: INTERVENTIONAL
primary_condition: Autonomous Cortisol Secretion (ACS)
countries: United States, Romania, United Kingdom
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05436639.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05436639"
ct_last_update_post_date: 2026-02-13
last_seen_at: "2026-05-12T06:27:40.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor

**NCT ID:** [NCT05436639](https://clinicaltrials.gov/study/NCT05436639)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Sparrow Pharmaceuticals
- **Conditions:** Autonomous Cortisol Secretion (ACS), ACTH-Independent Cushing Syndrome, ACTH-Independent Adrenal Cushing Syndrome, Somatic
- **Start Date:** 2023-07-01
- **Completion Date:** 2025-02-18
- **CT.gov Last Update:** 2026-02-13

## 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.

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **SPI-62 dose** (EXPERIMENTAL) — 2mg dose level of SPI-62. Active drug by mouth.

## 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).

## Primary Outcomes

- **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

## Locations (5)

- Mayo Clinic Cancer Center (MCCC) - Rochester, Rochester, Minnesota, United States
- Ohio State McCampbell Outpatient Care, Columbus, Ohio, United States
- C.M.D.T.A. Neomed, Brasov, Romania
- Institutul National de Endocrinologie, Bucharest, Romania
- King's College Hospital, London, United Kingdom

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.mayo clinic cancer center (mccc) - rochester|rochester|minnesota|united states` — added _(2026-05-12)_
- `locations.ohio state mccampbell outpatient care|columbus|ohio|united states` — added _(2026-05-12)_
- `locations.c.m.d.t.a. neomed|brasov||romania` — added _(2026-05-12)_
- `locations.institutul national de endocrinologie|bucharest||romania` — added _(2026-05-12)_
- `locations.king's college hospital|london||united kingdom` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05436639.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05436639*  
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