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Found 7 results

  1. Corcept Therapeutics is recruiting participants for its Phase 3 clinical trial evaluating relacorilant as a potential treatment for Cushing’s syndrome-related side effects such as high blood pressure and impaired glucose tolerance. Also, findings from the study “A Randomized-Withdrawal, Placebo-Controlled, Phase 3 Study to Assess the Efficacy and Safety of Selective Glucocorticoid Receptor Antagonist, Relacorilant, in Patients with Cushing Syndrome (GRACE Study),” were presented at the 2019 Annual Meeting of the Endocrine Society (ENDO), in New Orleans, Louisiana. In endogenous Cushing’s syndrome there is an “internal” culprit — usually a benign tumor — that makes the body produce too much of the hormone cortisol. The excessive amount of circulating cortisol can lead to serious problems, such as type 2 diabetes and high blood pressure. Relacorilant is designed to prevent the effects of excess cortisol by blocking one of its receptors, the glucocorticoid receptor. Results from a Phase 2 trial (NCT02804750) suggest that relacorilant may manage the effects of prolonged cortisol excess in Cushing’s patients faster and without the known side effects of approved medications like Korlym (mifepristone). Also, the treatment improved glucose tolerance and improved blood pressure in patients, suggesting it could be used to treat those with endogenous Cushing’s syndrome and concurrent type 2 diabetes mellitus, impaired glucose tolerance, and/or uncontrolled high blood pressure (hypertension). Corcept has now designed the GRACE Phase 3 trial (NCT03697109), a multicenter, double-blind, placebo-controlled, randomized-withdrawal study, to evaluate relacorilant’s safety and effectiveness in these patients. GRACE will be conducted in two stages. First, all patients will be given oral relacorilant each day for 22 weeks, at doses rising from 100 mg to a maximum of 400 mg. Those who complete that stage and show improvements in pre-specified parameters of glucose tolerance or hypertension will move into the second, randomized phase of the trial. Here, they will be randomly assigned to placebo or relacorilant at the same dose they received at the end of the first stage. This new round of treatment will last 12 weeks. Treatment-related adverse events (side effects) also will be assessed for up to 48 weeks (about 11 months) as a main outcome. Additional primary goals include changes in glucose tolerance and blood pressure between the end of the first and second stages of the study. Secondary objectives include identifying the proportion of patients achieving a response in glucose tolerance and high blood pressure criteria and the proportion of those who worsened at the end of the first stage, and the changes in quality of life throughout the study. Researchers plan to enroll 130 people in these U.S. cities: Indianapolis, Indiana; Metairie, Louisiana; Jackson, Mississippi; Albany, New York; Jamaica, New York; Wilmington, North Carolina; Miami, Florida; Summerville, South Carolina; El Paso, Texas; Oklahoma City, Oklahoma, and; Aurora, Colorado. More detailed information is available here. “We look forward to presenting new findings concerning cortisol modulation in patients with hypercortisolism,” Joseph K. Belanoff, MD, Corcept’s CEO, said in a press release.
  2. The glucocorticoid receptor antagonist CORT125134 is safe and has shown preliminary signs of efficacy in healthy volunteers participating in a Phase 1 trial, say researchers in England. Their study, “Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacological Effect of Orally Administered CORT125134: An Adaptive, Double-Blind, Randomized, Placebo-Controlled Phase 1 Clinical Study,” appeared in the journal Clinical Pharmacology in Drug Development.” Cortisol signaling is indirectly controlled by the glucocorticoid receptor (GR). When cortisol binds the GR, the receptor becomes activated and migrates to the nucleus, where it regulates the expression of many genes. This influences a myriad of processes, including inflammation, immune response and brain function. CORT125134, also known as relacorilant, is being developed by Corcept Therapeutics of Menlo Park, California, for Cushing’s disease patients and others who may benefit from it. The drug is a GR antagonist, blocking the receptor’s activity. In order to evaluate the safety and tolerability of CORT125134, and learn how it behaves in the body, Corcept researchers conduced a Phase 1 trial in healthy subjects. The British study, conducted at the Quotient Clinical in Nottingham, included 81 adults who received a single ascending-dose of CORT125134 or placebo, and 48 subjects who received multiple-ascending doses of the drug versus placebo. Single doses were tested in nine distinct groups. Six tested six different doses of CORT125134, one tested a 150 mg dose in subjects receiving a high-fat meal, and two groups included patients receiving prednisone (a well-known GR activator), prednisone plus Korlym (mifepristone), or prednisone plus CORT125134. Korlym is a medicine approved for Cushing’s patients with high blood sugar levels due to high cortisol in circulation. But the drug targets the progesterone receptor and is associated with side effects like pregnancy termination and irregular vaginal bleeding. Multiple doses, given for up to 14 days, were tested in four additional cohorts. Researchers observed that CORT125134 was rapidly absorbed and eliminated, presenting a suitable profile for once-daily dosing. Efficacy was determined by CORT125134’s ability to counteract the effects of prednisone. In addition, a single dose of 500 mg or multiple dosing with 250 mg had similar effects as those seen with 600 mg of Korlym — the therapeutic dose used for Cushing’s treatments. Most common treatment-related adverse events reported in the single-ascending dose part of the study were nausea, vomiting and thirst; most were mild. In those given multiple-ascending doses, adverse events included mild musculoskeletal and connective tissue disorders, as well as gastrointestinal system disorders. Multiple 500 mg doses exceeded the maximum tolerated dose, as it led to musculoskeletal symptoms that forced researchers to stop treatment. “This first-in-human study has demonstrated that CORT125134 is well tolerated following single doses up to 500 mg and repeated doses up to 250 mg once daily for 14 days,” researchers wrote. “Pharmacological activity was confirmed following the administration of a single 500-mg dose and daily administration of 250 mg.” Corcept is now enrolling participants into a Phase 2 open-label trial (NCT02804750) to evaluate CORT125134 in patients with Cushing’s syndrome. This trial is being conducted in the United States and Europe and will include 80 participants. Top-line results are expected in the first quarter of 2018. From https://cushingsdiseasenews.com/2017/10/10/phase-1-data-demonstrates-efficacy-safety-of-cort125134-in-healthy-volunteers/
  3. ISRCTN71291784 DOI 10.1186/ISRCTN71291784 A study to investigate the prevalence of pituitary gland dysfunction and it's risk factors following traumatic brain injuries (TBI) Condition category Nervous System Diseases Date applied 28/08/2017 Date assigned 14/09/2017 Last edited 14/09/2017 Prospective/Retrospective Prospectively registered Overall trial status Ongoing Recruitment status Not yet recruiting Plain English Summary Background and study aims The number of patients that are hospitalised or that die as a result of traumatic brain injury (TBI) is between 150 to 250 patients per 100,000 population per year. In Scotland this equates to 7,500 patients per year. Up to one third of these patients have long-term problems with their pituitary gland (a gland that regulations vital body function and hormones) function (also known as post TBI pituitary dysfunction or PTPD). This would make PTPD by far the commonest cause of hypopituitarism (when the pituitary gland fails to produce enough hormones). The pituitary gland sits at underneath the brain, where it is surrounded by bones of the skull base. It is therefore susceptible to damage during TBI as it may be injured by the surrounding bones. The pituitary gland is a key part of the endocrine system. The endocrine system is important for maintaining metabolism but also has key roles in regulating stress, energy, libido, bone and muscle strength. It also involved in regulating mental health and wellbeing. Pituitary hormone dysfunction is therefore a serious illness that can cause physical and neuropsychiatric disabilities that can affect the way people recover following TBI. PTPD can be reversed if diagnosed early treatment and an effective screening programme for diagnosing the patients most at risk could represent one of the most important interventions in the management of patient with TBI in the last few decades. The aim of this study is to investigate how common is pituitary dysfunction following traumatic brain injury (TBI). Who can participate? Patients aged 17 and older who have a primary TBI. What does the study involve? Participants undergo blood tests to assess their pituitary gland function one week, within the first month, between three and six months and between six and 12 months after TBI. Participants are checked for their hormones levels at the first stage of the study. During this first stage, 20 participatns receive an MRI (a scan using magnetics) or their brain. During the follow up stages, participants also have tests to assess their levels of growth hormone deficiencies (GHD) and secondary hypoadrenaism (SH). During the third and fourth stages of follow up, participants are asked to fill out questionnaires to assess their recovery following a TBI. What are the possible benefits and risks of participating? Not provided at time of registration. Where is the study run from? 1. Western General Hospital (UK) 2. Royal Infirmary of Edinburgh (UK) When is the study starting and how long is it expected to run for? September 2016 to August 2020 Who is funding the study? Edinburgh and Lothians Health Foundation (UK) Who is the main contact? Dr John Emelifeonwu Trial website Contact information Type Public Primary contact Dr John Emelifeonwu ORCID ID Contact details Bramwell Dott Building Western General Hospital Crewe Road South Edinburgh EH4 2XU United Kingdom Additional identifiers EudraCT number ClinicalTrials.gov number Protocol/serial number 2017/0146 Study information Scientific title Pituitary gland deficiencies after traumatic brain injury: An Outcomes and Prevalence Study Acronym PitSTOP Study hypothesis Post- traumatic brain injury (anterior) pituitary gland dysfunction (PTPD) is common following traumatic brain injury and clinical and radiological factors at the time of trauma may predict the risk of developing long-term PTPD. Ethics approval South East Scotland Regional Ethics Committee 02, 18/07/2017, ref: 17/SS/0043 Study design Multi-centre cross-sectional longitudinal cohort study Primary study design Observational Secondary study design Cross sectional study Trial setting Hospitals Trial type Diagnostic Patient information sheet See additional fiels Condition Traumatic brain injury Intervention After informed consent, recruited participants have blood tests to assess the function of their brain. These tests are all performed between 8am and 10am and the patients have to be 'fasted' (nothing to eat from midnight the night before) before the blood test. The blood tests are performed at four stages during follow up: Stage 1. In the first week after Traumatic brain injury (TBI) Stage 2. Within the first month after TBI Stage 3. At six months after TBI Stage 4. At 12 months after TBI Baseline levels of the following hormones are checked at all 4 stages. These include tests for: cortisol, insulin-like growth factor 1 (IGF-1), growth hormone (GH), prolactin, sodium, thyroid-stimulation hormone (TSH) and free thyroxine (fT4), testosterone levels in men and oestrogen levels in premenopausal women who do not have a regular menstrual cycle. All of these blood tests can be performed using 3.5mLs (approximately half a tablespoon) of blood. Also, during the first stage, a subset of participants will also have an magnetic resonance imaging (MRI) of their brain. These scans will be done at every stage of follow-up and will be done on the same day that the patients have their blood test. The MRI scans will be done to check whether there are any structural changes in the pituitary gland that can help predict likelihood of developing long-term PTPD. The MRI protocol lasts less than 30 minutes and will include the following sequences: T1-weighted 3-D volumetric sequences of the whole brain T2-weighted 2D sequences of the whole brain 3-D Susceptibility weighted imaging (SWI) sequences of the whole brain T1-weighted and T2-weighted fine slices (2mm) of pituitary gland 30 direction diffusion-tensor imaging (DTI) with axial and sagittal sequences During the second, third and fourth stages of follow up, in addition to the baseline blood tests, participants also have stimulation tests for growth hormone deficiencies (GHD) and secondary hypoadrenaism (SH): 1. Stimulation test for GHD: GHRH + Arginine test is used to test for GHD. During this test, a dose of a hormone called growth hormone release hormone (GHRH) (1 micrograms per Kg) is given with a protein called Arginine ( 30g in 100mLs) as an infusion over 30 minutes. Blood samples to check GH levels are then taken at 30 minutes and at 60 minutes after the start of the infusion. 2. Stimulation test for SH: Short Synacthen test (SST) is used to test for SH. During this test, a sample of blood is taken and then an intramuscular injection (into muscle, usually the shoulder muscle) of Synacthen is given. Synacthen is a synthetic hormone that mimics one of the hormones of the pituitary gland called ACTH. After it has been injected, two further blood tests are done 30 minutes and 60 minutes after the injection to analyse whether the Synacthen has caused an appropriate rise in the level of a hormone called cortisol. The injections that are given during the stimulation tests are either naturally occurring or synthetic versions of naturally occurring substances. They are tolerated by most patients but the tests are done under the supervision of an appropriate clinician, in case of any adverse reactions. The patients selected to have an MRI scan at the first stage have the scan repeated at all follow ups stages. Finally, during the third and fourth stages, participants are asked to complete the extended Glasgow Outcome Score (GOSE) to assesses functional recovery following TBI. This feasibility study is planned to test all aspects of the PitSTOP protocol prior to starting the main study. During this feasibility study, the first follow up stage will be omitted. Intervention type Biological/Vaccine Phase Drug names Primary outcome measures Prevalence of post TBI pituitary gland dysfunction (PTPD) is measured with pituitary function test (baseline measurements of serum thyroid stimulating hormone, free T4, testosterone, IGF-1 and cortisol) acutely (within 7 days), sub-acutely (within one month) and long-term (up to 6 months and up to 12 months) after TBI. Also a short synacthen test and GHRH + Arginine tests will be performed in the sub-acutely (within one month) and long-term (6 month and 12 months). Secondary outcome measures 1. Clinical and radiological markers are measured using the clinical information available at the time of presentation to hospital and serial MRI of the pituitary gland performed acutely, within one month and long-term (6 to 12 months) in a subset of patients to try to predict the occurrence of PTPD 2. Optimal timing for surveillance for PTPD using the clinical and radiological information detailed above 3. Functional recovery of patients with PTPD using Glasgow Outcome Score (eGOS) at end of study period (six to 12 months) Overall trial start date 01/09/2016 Overall trial end date 01/08/2020 Reason abandoned Eligibility Participant inclusion criteria 1. Primary traumatic Brain Injury (TBI) including multi trauma 2. Patients aged 17 years at the time of TBI 3. Informed consent obtained from participant Participant type Patient Age group Adult Gender Both Target number of participants 100 Participant exclusion criteria 1. Patients with a pre-existing endocrine diagnosis 2. Morbidly obese patients with BMI > 35 3. Unlikely to survive for the next 24 hours in the opinion of the Intensive care or Neurosurgical team treating the patient 4. Patients with known epilepsy 5. Patients on medications that are known to affect the hypothalamic-pituitary axis 6. Patients who are not able to consent Recruitment start date 01/12/2017 Recruitment end date 01/12/2019 Locations Countries of recruitment United Kingdom Trial participating centre Western General Hospital Crewe Road South Edinburgh EH4 2XU United Kingdom Trial participating centre Royal Infirmary of Edinburgh 51 Little France Crescent Old Dalkeith Road Edinburgh EH16 4SA United Kingdom Sponsor information Organisation University of Edinburgh Sponsor details Academic and Central Clinical Office for Research and Development College of Medicine & Veterinary Medicine University of Edinburgh The Queen's Medical Research Institute 47 Little France Crescent Edinburgh EH16 4TJ United Kingdom Sponsor type University/education Website http://www.accord.scot/ Funders Funder type Charity Funder name Edinburgh and Lothians Health Foundation Alternative name(s) ELHF Funding Body Type private sector organisation Funding Body Subtype foundation Location United Kingdom Results and Publications Publication and dissemination plan We intend to publish the results of this study by February 2020. IPD sharing statement: The datasets generated during and/or analysed during the current study are/will be available upon request from John Emelifeonwu johnemelifeonwu@gmail.com), Investigator Intention to publish date 01/02/2020 Participant level data Available on request Results - basic reporting Publication summary Publication citations From https://www.isrctn.com/ISRCTN71291784
  4. CLCI699C2302: A Phase III, Multi-center, Randomized, Double-blind, 48 Week Study with an Initial 12 Week Placebo-controlled Period to Evaluate the Safety and Efficacy of Osilodrostat in Patients with Cushing’s Disease Purpose In people with a disorder known as Cushing’s disease, levels of the hormone cortisol are very high in the urine and blood. Lowering cortisol levels relieves the symptoms of Cushing’s disease. Osilodrostat is an investigational drug that inhibits an enzyme needed for cortisol to be made. In this study, researchers are assessing the safety and effectiveness of osilodrostat in patients with Cushing¿s disease and observing its ability to reduce cortisol levels. In the first 12 weeks of the study, patients will receive osilodrostat or a placebo (inactive drug). After week 12 and continuing through week 48, all patients will receive osilodrostat. Patients will then have the option to continue taking osilodrostat for up to 100 weeks into the study, if they wish. Osilodrostat is taken orally (by mouth). Eligibility To be eligible for this study, patients must meet several criteria, including but not limited to the following: Patients must have Cushing¿s disease with elevated levels of cortisol in the urine. An acceptable amount of time must have passed between the completion of prior therapies and entry into the study, to allow for a sufficient “washout” period. This study is for patients ages 18 to 75. For more information about this study and to inquire about eligibility, please contact Dr. Eliza Geer at 646-888-2627. Protocol 17-351 Phase III Investigator Eliza B. Geer Co-Investigators Monica Girotra Diseases Pituitary Tumor Locations Memorial Sloan Kettering Memorial Hospital From https://www.mskcc.org/cancer-care/clinical-trials/17-351
  5. Participant enrollment has concluded for a phase 3 trial investigating the safety and efficacy of levoketoconazole, a cortisol synthesis inhibitor, for the treatment of endogenous Cushing’s syndrome, according to a press release from Strongbridge Biopharma, the drug’s developer. The single-arm, open-label SONICS study will include the 90 enrolled participants and may allow a small number of other patients to enroll also, according to the release. After titration to a therapeutic dose of levoketoconazole (Recorlev), participants will maintain treatment for 6 months, the primary efficacy endpoint. Longer-term evaluation for safety will extend to 1 year. A planned 6-month double blind, placebo-controlled, randomized withdrawal extension, dubbed LOGICS, will include approximately half of the participants from SONICS. “The need for a safe and effective, next-generation cortisol synthesis inhibitor, such as Recorlev, in the treatment of Cushing’s syndrome is substantial. Through achieving target enrollment in the SONICS study, we are one step closer to better understanding the clinical value of Recorlev and potentially bringing a new therapeutic treatment option to this community,” said Matthew Pauls, president and chief executive officer of Strongbridge Biopharma. The company expects to announce results of SONICS in the second quarter of 2018 and of LOGICS in the third quarter, according to the release. For more information: Clinicaltrials.gov/ct2/show/NCT01838551
  6. DESCRIPTION This trial is testing the safety and effectiveness of a new investigational drug for the treatment of Cushing's Syndrome. Under the supervision of qualified physicians, cortisol levels and symptoms of Cushing’s Syndrome will be closely followed along with any signs of side effects. The link below will take you to the trial website where you can review additional information and the patient screener. http://curec.lk/1X0J6kT
  7. RESEARCH STUDY SUMMARY An Open Label Study to Assess the Safety and Efficacy of COR-003 (2S, 4R ketoconazole) in the Treatment of Endogenous Cushing's Syndrome PURPOSEThe primary objectives of this study are to evaluate the efficacy of ascending doses of COR-003 in subjects with elevated levels of cortisol due to endogenous Cushing's Syndrome by assessment of reduction in Urinary Free Cortisol (UFC) concentrations and to identify the range of safe and effective doses of COR-003 that reduce mean UFC concentrations ≤ULN (upper limit of normal) of the assay at month 6 of the maintenance phase of dosing without a prior dose increase in that phase. TO LEARN MORE Review research study eligibility criteria » Contact information for clinical study » CW ID: 208654 Date Last Changed: June 25, 2015 Inclusion Criteria: Subjects eligible for enrollment in the study must meet all the following criteria: Male or female, ≥18 year of age Confirmed diagnosis of persistent or recurrent CS (with or without therapy) or newly diagnosed disease, if they are not candidates for surgery. Subjects in whom surgery will be delayed beyond 5 months will be permitted to participate. CS will be defined according to the criteria in the guidelines for diagnosis of CS (Nieman 2008). Previous medical records will be collected and used to support the diagnosis. The diagnostic criteria for appropriateness of inclusion of each subject into the study will be reviewed by the Medical Monitor. Diagnosis of the disease will be based on the association of clinical features of endogenous CS (see Appendix G in clinical protocol), review of past medication history, excluding exogenous sources of glucocorticoids, and abnormal values from two of the three following tests: Elevated 24-hour UFC levels ≥1.5X ULN of assay based on a minimum of 4 measurements from adequately collected urine. Urine may be collected on sequential days. Abnormal DST: Elevated 8 AM serum cortisol ≥1.8 ug/dL (50 nmol/L) after 1 mg dexamethasone orally at 11 PM the evening prior (if not conducted already in the diagnostic workup of the subject within the previous 6 months; previous test results and details of conduct will need to be available; normal serum cortisol ≤ 1.4 ug/dL) Elevated late night salivary cortisol concentrations (at least 2 measurements) >ULN at screening [NOTE: For subjects with estimated glomerular filtration rate (eGFR as determined by MDRD equation >40 and <60 mL/min) a late night salivary cortisol test (≥2 measurements) MUST be conducted in addition to measuring UFC levels to demonstrate evidence of CS.] Previously irradiated subjects will be allowed as long as the radiation treatment occurred ≥2 years ago and they do have stable UFC levels based on 24-hour urine collections for at least 6 months. The total number of previously irradiated subjects will not exceed 10.In the vast majority of subjects treated with radiation, efficacy is observed in <2 years. Confirmed diagnosis of persistent or recurrent endogenous hypercortisolemia as defined by UFC concentrations on repeated determinations (described in Inclusion #2) caused by either ACTH-dependent or ACTH-independent etiologies. Subjects on treatment for CS for whom treatment has been inadequate or not well tolerated must agree to the following minimum washout periods as determined by the nature of their treatment before baseline assessments are performed for participation in this study: Inhibitors of steroidogenesis: 2weeks; subjects on ketoconazole will be considered inadequately treated if they had failed to normalize UFC with a dose lower than or equal to 600 mg/day (also see Exclusion 7 below). Dopamine agonists: bromocriptine (2 week), cabergoline (8 weeks) Octreotide acetate LAR and lanreotide Autogel®: 12 weeks Lanreotide SR/long-acting pasireotide: 8 weeks Octreotide acetate (immediate release formulation) or short-acting pasireotide: 1 week Mifepristone (RU 486): 4 weeks Subjects on megasterol acetate (medroxyprogesterone acetate) must agree to a wash out of ≥6 weeks prior to receiving the first dose of the study medication. Female subjects should be either post-menopausal, surgically sterile, or women of child-bearing potential (WOCP) with a negative serum beta human chorionic gonadotropin (ßhCG) pregnancy test prior to entering the study and who agree to use an acceptable method of contraception, for the duration of the study. Condoms will be considered an acceptable form of contraceptive. 12-lead ECGs show no acute ischemia or clinically significant abnormality needing medical intervention Ability to comprehend and comply with procedures Agree to commit to participate in the current protocol Subjects provide written informed consent prior to any study procedures being performed (all subjects should be able to understand the informed consent form and any other documents that subjects are required to read) Exclusion Criteria: Subjects will be excluded from the study if any of the following criteria are met: De novo Cushing´s disease AND a candidate for pituitary surgeryIf surgery is to be delayed for >5 months, subjects may be allowed to participate in the trial while awaiting surgery, but must agree to complete this study prior to surgery. Subjects treated with radiation within the previous 2 years.In the vast majority of subjects treated with radiation, efficacy is observed in <2 years. Characteristics of pseudo-CS (see Appendix H in clinical protocol) Subjects with adrenal carcinoma Body Mass Index (BMI) exceeding 50 kg/m2 Body habitus preventing repeated venipuncture as required by protocol Subject is currently in another study or has received any investigational treatment (drug, biological agent or device) within 30 days or 5 half lives of screening, whichever is longer History of significant abnormalities in liver function tests on ketoconazole; history of therapeutic response failure to ketoconazole as defined by lack of normalization of UFC at a dose greater than 800 mg/day; lack of therapeutic response failure at maximum dose of mitotane Male and female subjects with QTc interval of >470 msec History of Torsades des Pointes or ventricular tachycardia or ventricular fibrillation Subjects with a non-endogenous source of hypercortisolemia such as exogenous source of glucocorticoids or therapeutic use of ACTH History of malignancy, other than thyroid, early stage prostate, squamous cell and basal cell carcinoma, within 3 years prior to the initial dose of the study medication. Subjects with history of carcinoma must have a life expectancy of >1 year and must be on stable doses of their specific therapies. Subjects with early stage prostate cancer undergoing no treatment due to low grade potential may be enrolled. Diagnosis of HIV History of persistent uncontrolled hypertension (>210/110 mmHg) despite medical intervention Subjects with hypercholesterolemia who are on current atorvastatin or simvistatin and not willing or unable to change to alternative therapies as noted (pravastatin, fluvastatin, and rosuvastatin) with 2 weeks of study screening Subjects with T2DM or with a history of hyperglycemic episodes requiring repeated, frequent hospitalizations Subjects with decreased renal function as defined by eGFR ≤40 mL/min, using Modified Diet in Renal Disease (MDRD) equation for estimating renal function (eGFR). Any other clinically significant medical condition, as determined by the Investigator that precludes enrollment and participation in the study through completion (for example, New York Heart Association (NYHA) class III or IV congestive heart failure). Known hepatic disease, other than mild to moderate hepatic steatosis consistent with fatty infiltration (non-alcoholic steatohepatitis [NASH]), with ongoing sustained biochemical activity (subjects with CS would be at risk for NASH) History of recurrent gall stone attacks or pancreatitis Positive for hepatitis B surface antigen (HbsAg) or positive hepatitis C test Liver function tests (LFT) must not be above the following cut-offs at screening: ALT and/or AST >3.0X ULN, alkaline phosphatase (AP) >1.5X ULN and total bilirubin >ULN. If all LFTs are within normal limits (WNL) and total bilirubin is elevated, examination of direct and indirect bilirubin may be conducted. Subjects with indirect total bilirubin up to 3X ULN are presumed to have Gilbert's syndrome and may be enrolled if all other LFTs are WNL. Presence of any other clinically significant medical condition, as determined by the Investigator that would preclude the subject from being able to follow instructions or to perform the necessary procedures (for example, psychiatric instability or severe disability) Compression of the optic chiasm Abnormal free T4. Subjects with TSH Excessive alcohol intake (>20 g per day for females (1.5 standard alcohol drinks) or >30 g per day for males (2.0 standard alcohol drinks) (a standard drink contains 14 g of alcohol: 12 oz of beer, 5 oz of wine or 1.5 oz of spirits) or drug abuse. (1.0 fluid oz (US) = 29.57 ml) The subject is currently taking any H2 receptor antagonists or proton-pump inhibitors (which inhibit absorption of COR-003). Only over-the- counter liquid and tablet antacids are allowed which should be used in moderation and taken a minimum of 2 hours after dosing of COR-003. The subject is receiving the following concomitant therapies: Weight loss medications (prescription or over the counter) Coadministration of COR-003 and drugs primarily metabolized by the cytochrome P450 3A4 enzyme system may result in increased plasma concentrations of the drugs that could increase or prolong both therapeutic and/or adverse effects. Therefore, appropriate dosage adjustments may be necessary. Medications with metabolism largely mediated by CYP3A4 and a narrow therapeutic margin include: cyclosporine, midazolam, triazolam, alprazolam, digoxin, coumarin-derivatives, phenytoin, rifampin, erythromycin, clarithromycin, loratadine, astemizole, terfenadine, nicotinic acids, resins, orlistat, sibutramine, HIV protease inhibitors, thiazolidinodiones, aliskiren, and spironolactone. A complete list of medications metabolized by or with an effect on cytochrome P450 3A4 is provided in Appendix K. Also see Section 10.2. Coadministration of strong inducers or inhibitors of CYP3A4 enzyme system that may interfere with COR-003 and cannot be discontinued prior to the start of the study (see Appendix K for the list) Statins other than pravastatin, fluvastatin and rosuvastatin Following herbal medicines should be avoided: St John's Wort, yohimbe and red rice yeast Potent topical steroids, containing urea or salicylic acid, which are applied over 20% of the body Inhaled steroid medications that exceed minimal to moderate use Carbamazipine, fenofibrate, carbenoxolone Excessive ingestion of genuine licorice Pregnant or lactating women Any other condition which would increase the risk of participation in the trial in the opinion of the Investigator ContactAdrine Gdakian UCLA School of Medicine 700 Tiverton Avenue, Factor Building Rm 9-240 Los Angeles, CA 90095 Phone: 310-825-5874 Fax: 310-206-5553 Jessica Rios-Santiago Coastal Metabolic Research Center University Medical Center, Dept. of Endocrinology 3454 Loma Vista Rd. Ventura, CA 93003 Phone: 805-658-8460 Fax: 805-658-8462 Betsy Parrott, RN, CCRC Rhode Island Hospital, Hallett Center for Diabetes and Endocrinology 900 Warren Avenue, Suite 300 East Providence, RI 02914 Phone: 401-444-2091 Fax: 401-444-4921 Becky Wood, CCRP Swedish Neuroscience Research 500 17th Ave Professional Bldg 303 Seattle, WA 98122 Phone: 206-320-7115
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