SPI-62 dose1 for Cushing Syndrome

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Eastern Virginia Medical School - Strelitz Diabetes Center, Norfolk, VA
Cushing Syndrome+6 More
SPI-62 dose1 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This will be a randomized, double-blind study to evaluate the efficacy, safety, and pharmacological effect of SPI-62 in subjects with hypercortisolism related to a benign adrenal tumor.

Eligible Conditions

  • Cushing Syndrome
  • hydrocortisone
  • ACTH-Independent Adrenal Cushing Syndrome, Somatic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cushing Syndrome

Study Objectives

2 Primary · 0 Secondary · Reporting Duration: Baseline to week 12

Baseline to week 12
Change in HbA1c at week 12
Baseline to week 6
Change in HbA1c at Week 6

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Cushing Syndrome

Trial Design

5 Treatment Groups

SPI-62 dose 3
1 of 5
SPI-62 dose 1
1 of 5
SPI-62 dose 2
1 of 5
SPI-62 dose 4
1 of 5
Placebo
1 of 5
Experimental Treatment
Non-Treatment Group

150 Total Participants · 5 Treatment Groups

Primary Treatment: SPI-62 dose1 · Has Placebo Group · Phase 2

SPI-62 dose 3
Drug
Experimental Group · 1 Intervention: SPI-62 dose 3 · Intervention Types: Drug
SPI-62 dose 1
Drug
Experimental Group · 1 Intervention: SPI-62 dose1 · Intervention Types: Drug
SPI-62 dose 2
Drug
Experimental Group · 1 Intervention: SPI-62 dose 2 · Intervention Types: Drug
SPI-62 dose 4
Drug
Experimental Group · 1 Intervention: SPI-62 dose 4 · Intervention Types: Drug
Placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline to week 12
Closest Location: Eastern Virginia Medical School - Strelitz Diabetes Center · Norfolk, VA
Photo of virginia 1Photo of virginia 2Photo of virginia 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Cushing Syndrome
0 CompletedClinical Trials

Who is running the clinical trial?

Sparrow PharmaceuticalsLead Sponsor
3 Previous Clinical Trials
86 Total Patients Enrolled
1 Trials studying Cushing Syndrome
26 Patients Enrolled for Cushing Syndrome
Frank Czerwiec, MDStudy ChairSparrow Pharmaceuticals
1 Previous Clinical Trials
26 Total Patients Enrolled
1 Trials studying Cushing Syndrome
26 Patients Enrolled for Cushing Syndrome

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
A patient with a documented benign adrenal nodule, with a size of ≤ 4 cm, homogenous texture, and non-contrast computerized tomography ≤ 20 HU attenuation or proven to be non malignant.
You have a HbA1c level of at least 5.7% but not at least 9.5%.
You have a 2-hour glucose level ≥ 7.
You have hypercholesterolemia with a total cholesterol > 3.9 mM (150 mg/dL).
You have hypertriglyceridemia with triglycerides > 2.3 mM (200 mg/dL).
You have osteopenia with a BMD Z-score < -2.0 or T-score < -1.
You have a history of minimally traumatic or osteoporotic fracture or hypertension with resting supine blood pressure > 130 but < 180 mmHg systolic or > 85 but < 120 mmHg diastolic.
A morning serum cortisol > 50 nM (1.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.