Do you have a benign adrenal tumor or Cushing’s Syndrome?
Are these conditions causing additional health concerns that you must manage daily?
If so, you may be eligible to participate in a clinical research study.
Why this Matters
If you have high blood pressure, high cholesterol, diabetes or pre-diabetes, osteoporosis (bone loss), or reproductive issues, and you have a benign tumor on your adrenal gland or pituitary gland, it is possible that these conditions are caused by elevated hormone levels produced by that tumor.
Sparrow Pharmaceuticals is conducting clinical trials of an investigational drug that may help patients who have excessive cortisol as a result of their tumor or Cushing’s disease.
The Science
Your body’s glands produce hormones that affect many physical and chemical processes in your body such as the control of blood pressure, blood sugar, and immune responses. Tumors on your adrenal glands or pituitary gland can cause too much of the hormone called cortisol to be produced in your body.
This is called hypercortisolism (excessive cortisol in the body) and has been linked to high blood pressure, high cholesterol, diabetes, osteoporosis (bone loss), reproductive issues, and more.
Certain tissues of the body, like the liver, brain, fat, and bone, produce a substance called “HSD-1” that helps to regulate cortisol. This is the target of Sparrow’s study drug SPI-62. SPI-62 is intended to regulate HSD-1 and therefore cortisol levels.
The goal of SPI-62 is to hopefully regulate the excess production of cortisol in the body and alleviate symptoms of hypercortisolism and the associated health concerns such as high blood pressure, high cholesterol, diabetes, and bone loss caused by the excessive cortisol levels.
Our Trials
Sparrow Pharmaceuticals currently has two ongoing studies for people with various forms of hypercortisolism. To learn more about the studies or find out if you may be eligible, click on the study-specific link:
Autonomous cortisol secretion (ACS) and adrenal Cushing’s syndrome (aCs)
Adrenocorticotropic hormone-dependent Cushing’s Syndrome (ACTH Cushing’s)
About the Study Drug
The investigational drug being tested in these studies is an oral tablet called SPI-62. It may reduce the conversion of cortisone into cortisol in the body’s tissues. The ACSpire and RESCUE studies will help to better understand the drug’s safety and efficacy as a potential treatment for hypercortisolism, as well as any other effects it might have.
The ACSpire study is for people with hypercortisolism (higher than normal levels of the adrenal “stress” hormone known as cortisol) related to a benign adrenal tumor. This is also known as autonomous cortisol secretion (ACS) or adrenal Cushing’s syndrome (aCs).
Participation will continue in an open-ended fashion until SPI-62 either becomes commercially available or is terminated.
You may qualify to participate if you:
- are an adult diagnosed with a benign (no cancer) adrenal tumor
- you complete a blood test that shows higher than normal cortisol levels (caused by the adrenal tumor)
- have one or more symptoms of elevated cortisol levels, such as high cholesterol, low bone density, and/or high blood pressure
- do not have high cortisol due to a tumor producing adrenocorticotropic hormone (ACTH) or from taking medications containing cortisol or cortisone
Your medical history and other criteria will be checked to see if you can take part in the ACSpire study.
The study is divided into several parts:
1: Screening Period
(up to 1 month)
Once you have been informed about the study and signed the informed consent form, you will become a participant in the study. All participants will provide samples of blood and urine as well as information about their medical history. Blood pressures, electrocardiogram (ECG), and DEXA (bone) scan will be done per standard of care. An ECG measures your heart rhythm, and a DEXA scan is an X-ray scan that measures the density of your bones and the amount of muscle and fat in your body.
2: Study Treatment Period
(3 months)
If you qualify, you will be prescribed SPI-62 throughout the study period or for as long as you are willing to take it and comply with follow-up requirements. During the first year, visits will occur at 1 month, 3, 6, 9, and 12 months after treatment initiation. Following the visit at 12 months, visits will be performed quarterly. All visits should be performed in person, however remote or telemedicine visits may be conducted if warranted.
3: End of Study Visit
At the end of the study or should you fully withdraw consent for further data collection a final study visit will be conducted.
For more study details visit https://clinicaltrials.gov/ct2/show/NCT05436639
The RESCUE study is for people with Cushing’s syndrome caused by a non-adrenal tumor (tumor in the pituitary gland or some other location). This is also called ACTH-dependent Cushing’s disease or syndrome (ACTH stands for adrenocorticotropic hormone).
Participation lasts 7 months and requires at least 11 visits to the research site. Four of these visits may be done remotely at your home.
You may qualify to participate if you:
- are an adult diagnosed with of ACTH-dependent Cushing’s disease or syndrome
- have one or more symptoms of Cushing’s syndrome, such as type 2 diabetes, pre-diabetes, or impaired glucose tolerance, high cholesterol, low bone density (osteoporosis), and/or high blood pressure (hypertension)
- have not had fractionated radiation therapy for Cushing’s within the past 2 years, or conventional radiation therapy within 4 years
- have not had both adrenal glands removed (bilateral adrenalectomy)
Your medical history and other criteria will be checked to see if you can take part in the study.
If you complete the trial, you may be eligible for the extended open-label portion of the trial.
The study is divided into several parts:
1: Screening and Baseline Period
(about 1 month)
You will provide samples of blood and urine as well as information about your medical history. Blood pressures, electrocardiogram (ECG), tumor MRI and DEXA (bone) scan will be done. An ECG measures your heart rhythm, and a DEXA scan is an X-ray scan that measures the density of your bones and the amount of muscle and fat in your body.
2: Study Treatment Period
(about 5 months)
If you qualify, you will be randomly assigned (like rolling dice) to 1 of 2 different dosing schedules that alternate between the study drug and placebo (an inactive substance). You will take the study treatment once each day. You will visit the study site 8 times during this period for study-related tests, questionnaires, and procedures. Four of these visits may occur at your home. Also, you will perform other tests (urine and home automatic blood pressures) between each visit to check on your health.
3: Follow-up Period
(3 weeks)
You will have one final visit about 3 weeks after your last dose of the study drug to check on your health, provide urine and blood samples.
4: Long Term Extension
(TBD)
Long term safety will be monitored during an open-label (all participants are on active study drug) extension designed to provide study drug to qualifying participants who completed the full 24 weeks of the main trial. During the extension trial, local laboratory testing will be limited to that used for standard of care follow-up of your clinical conditions.
For more study details visit https://clinicaltrials.gov/ct2/show/NCT05307328
Resources
What is a clinical study?
A clinical study (also known as a clinical trial) is designed to learn more about a drug’s ability to treat a specific disease or condition. Regulatory agencies such as the United States Food and Drug Administration (FDA) or the European Medicines Agency use the results of clinical studies to decide if an investigational treatment should be made available to patients and if changes should be made to how approved drugs should be prescribed.
How are my rights protected?
Every clinical study is reviewed by an Institutional Review Board (IRB) or Ethics Committee (EC), which helps ensure that the study is conducted properly and that the rights of study participants are protected. Clinical studies are conducted by trained medical professionals who monitor the health of participants throughout the study.