[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Crinetics Pharmaceuticals Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":230},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,63,92,132,159,182,205],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100602879","phase-1-a-study-to-investigate-safety-and-effectiveness-of-crn09682-in-participants-with-sst2-expressing-nens-and-other-solid-tumors-100602879",false,"NCT07129252","A Study to Investigate Safety and Effectiveness of CRN09682 in Participants With SST2-Expressing NENs and Other Solid Tumors","A Phase 1\u002F2 Dose Escalation Study of CRN09682 With an Expansion Phase in Participants With Progressive Metastatic Somatostatin Receptor Type 2 (SST2)-Expressing Neuroendocrine Neoplasms (NENs) and Other SST2-Expressing Solid Tumors","BRAVESST2","Inclusion Criteria:\n\n* Have a histological diagnosis of metastatic or locally advanced inoperable NET, NEC, or other solid tumors that have confirmed radiological progression.\n* Have one or more measurable disease location per RECIST version 1.1.\n* Have a tumor that expresses SSR confirmed by SSR imaging.\n* Have an ECOG performance status of 0, 1, or 2.\n\nExclusion Criteria:\n\n* Have tumor progression while undergoing a course of PRRT or within 6 months of completing PRRT.\n* Have brain metastases unless asymptomatic and stable for at least one month for participants with SCLC or LCLC or at least 3 months for participants with other non-NET solid tumors.\n* Use of anticancer agents within specified intervals prior to the first dose of study drug.\n* Had surgery, chemoembolization, or radiofrequency ablation within 90 days prior to first dose of study drug.\n* Prior participation in any intervention clinical study within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug.\n* Participants with carcinoid syndrome.\n* Secondary malignancy: participants who have any other malignancy known to be active or treated within 3 years of the start of screening, with the exception of treated cervical intraepithelial neoplasia, superficial (noninvasive) bladder cancer, and non-melanoma skin cancer.\n* Have prior treatment with MMAE.\n* Have hypersensitivity or history of anaphylactic reaction to octreotide, other SSAs, and\u002For MMAE.","ALL","18 Years",{"count":20,"type":21},150,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This Phase 1\u002F2, multicenter, open-label, FIH study aims to evaluate the safety, tolerability, PK, and preliminary antitumor activity of CRN09682 in participants with SST2-expressing NENs and other solid tumors. The study includes a Dose Escalation Phase to determine the MTD and DLTs. Following MTD identification, additional participants will be enrolled at the expansion dose to further assess safety, tolerability, PK, and antitumor activity.",[28,29,30],"SST2-positive Neuroendocrine Neoplasms","Neuroendocrine Tumors","Neuroendocrine Neoplasm",[32,33,30,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49],"CRN09682","Crinetics","NEN","Neuroendocrine Tumor","NET","MMAE","SST2","Somatostatin","Metastatic","Solid Tumor","Dose Escalation","Dose Expansion","Phase 1","SSTR+","Phase 2","Phase 1\u002F2","Neuroendocrine Carcinoma","NEC","RECRUITING","2026-06-30",{"date":53,"type":54},"2026-07-01","ACTUAL",{"date":56,"type":54},"2025-11-26",{"date":58,"type":21},"2029-08",{"name":60,"class":61},"Crinetics Pharmaceuticals Inc.","INDUSTRY",26,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":90,"locationsCount":91},"100570867","phase-2-an-extension-study-to-evaluate-safety-and-efficacy-of-atumelnant-in-participants-with-congenital-adrenal-hyperplasia-100570867","NCT06712823","An Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia","An Open-label, Long-term Extension Study to Evaluate Safety and Efficacy of Atumelnant in Participants With Congenital Adrenal Hyperplasia (CALM2-CAH)","CALM2-CAH","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all the following criteria apply:\n\n1. Participants with CAH who have completed the Treatment Period in a Crinetics parent atumelnant CAH study, and in the opinion of the Investigator had an acceptable benefit-risk assessment in the completed study and would benefit from continued dosing in this extension study.\n\n   1. Group 1: Participants meeting the above criteria and did not have study drug administration interrupted between End of Trial (EOT) of the parent study and the commencement of the OLE study.\n   2. Group 2: Participants meeting the above criteria but had study drug administration interrupted between EOT of the parent study and the commencement of the OLE study.\n2. Female participants who engage in heterosexual intercourse must:\n\n   1. Be of nonchildbearing potential, defined as either surgically sterile (ie, hysterectomy, bilateral salpingectomy for at least 3 months, or bilateral oophorectomy), OR\n   2. Be postmenopausal with at least 1 year of amenorrhea. In participants with less than 1 year of amenorrhea, confirmation is required with 2 follicle-stimulating hormone (FSH) measurements. A documented, historical test result measured prior to Screening may be used as 1 of the 2 measurements. The FSH value should be ≥30 IU\u002FL to confirm menopausal status, OR\n   3. Agree to use a highly effective method of contraception from the beginning of Screening until at least 2 weeks after the last dose of study drug. Contraceptive use by men and women also should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Periodic abstinence (ie, calendar, ovulation, symptothermal, postovulation methods) and withdrawal are not acceptable methods of contraception.\n3. Male participants agree to use a condom when sexually active with a female partner of childbearing potential from Screening until at least 2 weeks after the last dose of study drug (or be surgically sterile \\[ie, vasectomy with a confirmed absence of sperm in ejaculate\\]; or agree to remain abstinent on a long-term and persistent basis). Male participants should also agree to not donate sperm for the duration of the study and until at least 2 weeks after the last dose of study drug.\n4. Participants are willing and able to give signed informed consent, including compliance with the requirements and restrictions listed in the Informed Consent Form (ICF).\n5. Participants are willing and able to comply with the study procedures as specified in the protocol and comply with the study treatment.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Any medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the participant's safety or ability to complete the study.\n2. Participants have known history of (that is within the past 12 months), or current alcohol or drug abuse.\n3. Participants have any mental condition rendering him\u002Fher unable to understand the nature, scope, and possible consequences of the study, and\u002For evidence of poor compliance with medical instructions.\n4. Participants have a known allergy or hypersensitivity to any of the test materials or related compounds, including being at high risk of adrenal insufficiency as judged by the Investigator.\n5. Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study.\n6. Participant is an employee or immediate family member of an employee of Crinetics.\n7. Participants who have been dosed with an investigational drug (other than atumelnant) in any prior clinical study within 60 days or 5 half-lives (whichever is longer) prior to informed consent or plan to use an investigational drug in another study.\n8. Participants who have had an active malignant disease within the last 5 years prior to Screening excluding dermal squamous or basal cell carcinoma of the skin with complete local excision or resected cervical carcinoma in situ.\n9. Participants who are committed to an institution by virtue of an order issued either by the judicial or the administrative authorities.\n\n   Specific for Participants Not Currently Receiving Atumelnant\n10. Participants with any clinically significant abnormal laboratory test during Screening or clinically significant concomitant disease other than CAH including but not limited to cardiovascular disease; moderate or severe renal insufficiency (estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m2 using Chronic Kidney Epidemiology Collaboration \\[CKD-EPI\\] formula) at Screening; or Significant liver disease or alanine aminotransferase (ALT) and\u002For aspartate aminotransferase (AST) \\>3× upper limit of normal (ULN), and\u002For total bilirubin \\>1.5×ULN during Screening. Participants with previously diagnosed Gilbert's syndrome not accompanied by other hepatobiliary disorders and associated with total bilirubin \\\u003C3.5 mg\u002FdL (\\\u003C51.3 μmol\u002FL) will be permitted.\n11. Participants with a history of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic glucocorticoid therapy.\n12. Participants with a history of major surgery\u002Fsurgical therapy for any cause within 4 weeks prior to Screening.\n13. Participants with poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5% (≥69 mmol\u002FmL).\n14. Participants with hypothyroidism who are not receiving adequate hormone replacement therapy based on thyroid hormone levels measured at the time of Screening, as determined by the Investigator.\n15. Participant has an average (of 3 electrocardiograms \\[ECGs\\]) Fridericia's corrected QT (QTcF) interval \\>450 milliseconds (msec) (men) or \\>470 msec (women), time interval between P and R waves (PR interval) \\>220 msec, time interval of the QRS complex (QRS) interval \\>120 msec, second- or third-degree atrioventricular block, left bundle branch block, or hemiblock at Screening.","16 Years","74 Years",{"count":74,"type":21},200,[25],"The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of atumelnant (CRN04894).",[78,79],"Congenital Adrenal Hyperplasia","Classic Congenital Adrenal Hyperplasia",[78,81,82,83],"CAH","CRN04894","atumelnant","2026-06-24",{"date":86,"type":54},"2026-06-29",{"date":88,"type":54},"2025-02-25",{"date":58,"type":21},{"name":60,"class":61},13,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":22,"phases":102,"briefSummary":104,"conditions":105,"keywords":115,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100599635","phase-3-carcinoid-syndrome-efficacy-study-featuring-an-oral-daily-paltusotine-regimen-100599635","NCT07087054","Carcinoid Syndrome Efficacy Study Featuring an Oral Daily Paltusotine Regimen","A Randomized, Parallel Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Paltusotine in Adults With Carcinoid Syndrome Due to Well-Differentiated Neuroendocrine Tumors","CAREFNDR","Inclusion Criteria:\n\n* Male or female ≥18 years of age, at the time of Screening.\n* Willing and able to comply with the study procedures as specified in the protocol, including at least 70% compliance with the study diary for the 2-week period.\n* Documented carcinoid syndrome requiring medical therapy. Participants must exhibit symptoms of flushing with or without frequent BMs as follows:\n\n  * For participants who are naïve\u002Fnot currently treated with somatostatin receptors ligands (SRL), they must exhibit an average of \\>1 flushing episode\u002Fday over a period of 14 days\n  * For participants who will wash out from SRL treatment, they must be symptomatically controlled and exhibit an increase in daily average flushing episodes and an average of \\>1 flushing episode\u002Fday over a period of 14 days during the Washout Period.\n* Evaluable documentation of locally advanced or metastatic histopathologically confirmed well-differentiated neuroendocrine tumor(s) \\[NETs\\].\n* No significant disease progression as assessed by the Investigator within the last 6 months before randomization.\n\nExclusion Criteria:\n\n* Diarrhea attributed to any condition(s) other than carcinoid syndrome.\n* Uncontrolled\u002Fsevere diarrhea associated with significant volume contraction, dehydration, or hypotension.\n* Requires second line treatments (eg, telotristat) for control of carcinoid syndrome symptoms in the opinion of the Investigator.\n* Treatment with specific NET therapy \\\u003C4 weeks before Screening (such as everolimus or sunitinib) or hepatic embolization, radiotherapy, peptide receptor radionuclide therapy (PRRT), and\u002For tumor debulking \\\u003C12 weeks before Screening.\n* Major surgery within 8 weeks before Screening.\n* History of another primary malignancy \\\u003C3 years prior to the date of randomization, except for adequately treated basal or squamous cell carcinoma of the skin, cancer of the breast has been completely locally excised and carcinoma in situ of the cervix has also been resected, previously treated malignancy, if all treatment for that malignancy was completed at least 3 years prior to first dose of study treatment, and no current evidence of disease, concurrent malignancy determined to be clinically stable and not requiring treatment.\n* Diabetes mellitus treated with insulin for less than 6 weeks prior to the study entry.\n* Poorly controlled diabetes mellitus defined as having a hemoglobin A1c (HbA1c) ≥8.5%\n* Unable to administer short-acting (SA) octreotide (octreotide acetate injection), or prior nonresponse documented with somatostatin agonists.\n* Clinically significant concomitant disease or indicator of disease that is not a result of the primary disease under study, including but not limited to cardiovascular disease, estimated glomerular filtration rate 2×upper limit of normal \\[ULN\\], and\u002For total bilirubin (TB) \\>1.5×ULN. (Participants with previously diagnosed Gilbert's syndrome not accompanied by other hepatobiliary disorders and associated with TB\n* Alcohol or drug abuse is not permitted at any time during the study\n* Diagnosed with symptomatic cholelithiasis",{"count":101,"type":21},141,[103],"PHASE3","A Phase 3, randomized, double-blinded, placebo-controlled study to evaluate the efficacy and safety of paltusotine treatment vs placebo as well as the long-term safety of paltusotine in adults with carcinoid syndrome due to well-differentiated neuroendocrine tumors. The purpose of this study is to continue the evaluation of the safety, efficacy, and pharmacokinetics (PK) of paltusotine in participants with carcinoid syndrome.",[106,107,108,109,110,111,112,113,114],"Carcinoid Syndrome","Carcinoid","Carcinoid Tumor","Carcinoid Tumor of Ileum","Carcinoid Tumor of Cecum","Carcinoid Tumor of Liver","Carcinoid Tumor of Pancreas","Carcinoid Syndrome Diarrhea","Carcinoid Intestine Tumor",[116,117,118,119,120,121,122],"Neuroendocrine tumor","Paltusotine","CRN00808","Carcinoid syndrome","Lanreotide","Octreotide","Somatostatin agonist","2026-06-23",{"date":125,"type":54},"2026-06-25",{"date":127,"type":54},"2025-11-19",{"date":129,"type":21},"2030-01",{"name":60,"class":61},51,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":17,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":146,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},"100605232","phase-2-a-study-in-pediatric-participants-with-congenital-adrenal-hyperplasia-balance-cah-100605232","NCT07159841","A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)","A Phase 2\u002F3 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Atumelnant Treatment in Pediatric Participants With Congenital Adrenal Hyperplasia Including a Long-Term Extension","Inclusion Criteria:\n\nPart A and B participants are eligible to be included in the study only if all of the following criteria apply:\n\n1. Male or female at birth, between 1 to \\\u003C18 years of chronological age at the time of signing the Informed Consent Form (ICF).\n2. Have a medically confirmed diagnosis of classic CAH due to 21-hydroxylase deficiency (21-OHD) based on standard medically accepted criteria such as elevated 17-OHP level, confirmed CYP21A2 genetic testing, positive newborn screening with confirmatory second tier testing, or cosyntropin stimulation.\n3. Participants must have an elevated morning serum A4 level \\>ULN during Screening obtained prior to morning glucocorticoid (GC) administration.\n4. Participants must be on a stable supraphysiologic GC replacement therapy for at least one month prior to Screening.\n5. Compliance, as judged per Investigator discretion, with GC replacement and mineralocorticoid replacement (if applicable) regimen documented during the Screening Period.\n6. Biochemical euthyroidism as determined by the Investigator.\n\nPart C inclusion criteria require participants to complete treatment in either Part A or Part B and in the Investigator's opinion it would benefit the participant to continue in Part C, regardless of age.\n\nExclusion Criteria:\n\nPart A and Part B: Individuals in Part A and Part B who meet any of the following criteria will be excluded from participation in this study:\n\n1. Diagnosis of any form of CAH other than classic 21-OHD.\n2. Participants treated with other GCs within 30 days of Screening.\n3. Stress dose of GC therapy within 2 weeks of start of Screening, defined as any dose above the normal maintenance dose, including but not limited to intravenous (IV) or intramuscular (IM) hydrocortisone.\n4. Use of growth hormones within 1 week of start of Screening for short acting, or within 6 weeks of start of Screening for long acting.\n5. Use of a corticotropin-releasing factor receptor antagonist within 14 days of Screening.\n6. History of cancer excluding cured\u002Ftreated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.\n7. Abnormal sleep\u002Fwake cycles (as determined by the Investigator).\n8. Female participants who are pregnant or lactating.\n9. Participants who have been dosed with an investigational drug (including atumelnant) in any prior clinical study within 60 days or 5 half-lives (whichever is longer) prior to the first dose.\n10. Individuals in Part C who do not meet the Part C Inclusion Criteria.","1 Year","17 Years",{"count":142,"type":21},153,[25,103],"The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of atumelnant treatment in pediatric participants with classic congenital adrenal hyperplasia (CAH).",[78,79],[78,81,82,147,148,149],"Atumelnant","Pediatric","Balance-CAH","2026-06-12",{"date":152,"type":54},"2026-06-16",{"date":154,"type":54},"2026-01-22",{"date":156,"type":21},"2030-03",{"name":60,"class":61},35,{"id":160,"slug":161,"hasResults":11,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":4,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":166,"targetDuration":4,"studyType":22,"phases":167,"briefSummary":168,"conditions":169,"keywords":170,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},"100604026","phase-3-a-study-to-evaluate-atumelnant-in-adults-with-congenital-adrenal-hyperplasia-100604026","NCT07144163","A Study to Evaluate Atumelnant in Adults With Congenital Adrenal Hyperplasia","A Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atumelnant in Adult Participants With Classic Congenital Adrenal Hyperplasia (Calm-CAH)","Inclusion Criteria:\n\n1. Male or female, between ≥18 to \\\u003C75 years of age at the time of signing the ICF.\n2. Willing and able to understand and adhere to the study procedures as specified in the protocol and comply with the study treatment.\n3. Have classic CAH due to 21-OHD confirmed by the Investigator.\n4. Participants with Visit 2 levels of morning serum A4 as follows:\n\n   * A4 \\>ULN and treated with \\\u003C11 mg\u002Fm2\u002Fday (physiologic) GC doses\n   * OR normal A4 (\\>0.5xULN to ≤1xULN) and treated with ≥14 mg\u002Fm2\u002Fday GC doses\n   * OR A4 \\>ULN and treated with ≥11 mg\u002Fm2\u002Fday GC doses.\n5. On a stable (defined as no dose change of \\>5 mg\u002Fday hydrocortisone equivalent within 2 months prior to Screening) regimen of GC replacement (e.g., hydrocortisone, prednisolone, prednisone, methylprednisolone, meprednisone, dexamethasone, cortisone acetate) at the time of informed consent.\n6. If treated with mineralocorticoids (fludrocortisone), the dose should be stable for at least 1 month prior to Screening without orthostatic hypotension, and with serum sodium and potassium in the normal range.\n7. If on estrogen therapy (any route), the dose must be stable for at least 3 months prior to Screening.\n\nExclusion Criteria:\n\n1. Diagnosis of any form of CAH other than classic 21-OHD.\n2. History of bilateral adrenalectomy, hypopituitarism, or other condition requiring chronic GC therapy.\n3. Clinically significant medical condition or abnormal laboratory tests, as judged by the Investigator, other than CAH.\n4. Concomitant mental condition rendering him\u002Fher unable to understand the nature, scope, and possible consequences of the study, and\u002For evidence of poor compliance with medical instructions.\n5. History of cancer excluding cured\u002Ftreated dermal squamous or basal cell carcinoma or cervical carcinoma in situ.\n6. Women who are pregnant or lactating or, if of childbearing potential, who are unwilling to use highly effective contraception as described in this study. Male participants who are unwilling to use highly effective contraception as described in this study.\n7. Known history of, or concern for, risk of hypersensitivity reaction to atumelnant or any of its excipients.\n8. Participants with an increased risk of developing adrenal insufficiency as judged by the Investigator.\n9. Severe erythrocytosis as judged by the Investigator.\n10. Use of atumelnant prior to screening.",{"count":20,"type":21},[103],"The purpose of this study is to evaluate the efficacy, safety, PK, and PD of atumelnant in adults with classic CAH due to 21-OHD.",[78,79],[78,81,82,147,171,172],"Adult","Calm-CAH","2026-06-02",{"date":175,"type":54},"2026-06-04",{"date":177,"type":54},"2025-12-11",{"date":179,"type":21},"2027-05",{"name":60,"class":61},45,{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":22,"phases":191,"briefSummary":192,"conditions":193,"keywords":197,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},"100501085","phase-1-a-study-to-evaluate-the-safety-and-pk-of-crn04894-for-the-treatment-of-cushings-syndrome-100501085","NCT05804669","A Study to Evaluate the Safety and PK of CRN04894 for the Treatment of Cushing's Syndrome","A Phase 1b\u002F2a Open-label Multiple-ascending Dose Exploratory Study of CRN04894 in ACTH-dependent Cushing's Syndrome (Cushing's Disease or Ectopic ACTH Syndrome)","Inclusion Criteria:\n\n1. Adult male or female, aged 18 years or more\n2. Evidence of chronic 'active' ACTH-dependent Cushing's syndrome\n3. Evidence of acutely 'active' ACTH-dependent Cushing's syndrome within 10 days of Day 1\n4. Participants with documented ACTH-dependent Cushing's syndrome taking short-acting steroidogenesis inhibitors (ketoconazole, levoketoconazole, osilodrostat, or metyrapone) may participate after a washout period of at least 5 days, if they meet other study inclusion criteria, relative to Investigator's judgment. Participants with documented ACTH-dependent Cushing's syndrome taking cabergoline may participate after a washout period of at least 14 days, if they meet other study inclusion criteria\n\nExclusion Criteria:\n\n1. Women who are pregnant or lactating\n2. History of bilateral adrenalectomy\n3. Previous pituitary MRI findings of a putative ACTH-secreting lesion within 3 mm of the optic chiasm\n4. Presence of any known malignancy\n5. Use of mitotane\n6. Previous unsuccessful surgery for Cushing's syndrome within 6 weeks",{"count":190,"type":21},18,[24,25],"A Phase 1b\u002F2a, first-in-disease, open-label, multiple-ascending dose exploratory study to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamic biomarker responses associated with CRN04894 (an adrenocorticotropic hormone \\[ACTH\\] receptor antagonist) in participants with ACTH-dependent Cushing's syndrome (Cushing's disease or Ectopic ACTH Syndrome \\[EAS\\])",[194,195,196],"Cushing Syndrome","Cushing Disease","Ectopic ACTH Syndrome",[194,195,196,82,83],{"date":175,"type":54},{"date":200,"type":54},"2023-10-12",{"date":202,"type":21},"2026-10",{"name":60,"class":61},1,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":212,"sex":17,"minAge":213,"maxAge":214,"enrollmentInfo":215,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":227,"leadSponsor":229,"locationsCount":204},"100636776","phase-1-drug-drug-interaction-study-of-atumelnant-in-healthy-participants-100636776","NCT07570082","Drug-Drug Interaction Study of Atumelnant in Healthy Participants","A Phase 1, Open-Label, Two-Cohort Study to Assess the Effect of a Strong CYP3A4 Inducer on the Pharmacokinetics of Atumelnant and the Effect of Atumelnant on the Pharmacokinetics of CYP3A4, P-gp, and MATE1\u002F2-K Substrates in Healthy Participants","Inclusion Criteria:\n\n1. Healthy adult females of non-childbearing potential (Section 14.2) or healthy adult males, 19-55 years of age, inclusive, at the screening visit.\n2. BMI ≥18.0 and ≤32.0 kg\u002Fm2 at the screening visit.\n3. Is willing and able to comply with all study procedures and restrictions, including fasting and consumption of protocol-specified standardized meal for required study measurements; inpatient admission; follow-up contact; receipt of rescue therapy, if necessary; abstinence from tobacco, alcohol, drugs, and from strenuous unaccustomed exercise and sports (defined as greater than 30 minutes per day) during the study period.\n4. Normal adrenocorticotropic hormone (ACTH)-stimulated cortisol test at the screening visit and does not have signs and symptoms of adrenal insufficiency as deemed by the PI or designee.\n\nExclusion Criteria:\n\n1. Is mentally or legally incapacitated or has significant emotional problems at the time of the screening visit or expected during the conduct of the study.\n2. History or presence of clinically significant medical or psychiatric condition or disease in the opinion of the PI or designee.\n3. Female participant with a positive pregnancy test at the screening visit or at first check-in or who is lactating.\n4. Female participant of childbearing potential.\n5. Had prior treatment with atumelnant.\n6. Participation in another clinical study within 30 days or received any investigational drug within 5 half-lives prior to the first dosing, whichever is longer. The time window will be derived from the date of the last blood collection or dosing, whichever is later, in the previous study to Day 1 of the current study.\n7. History or presence of hypersensitivity or idiosyncratic reaction to the study interventions or related compounds.\n8. Has a blood loss ≥500 mL or donated blood within 3 months prior to the first dosing.\n9. Unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, vitamin supplements, or other food supplements within 14 days or 5 half-lives prior to the first dosing, whichever is longer.",true,"19 Years","55 Years",{"count":216,"type":21},46,[24],"This study aims to evaluate the impact of strong CYP3A4 induction on the pharmacokinetics (PK) of atumelnant, as well as the effect of atumelnant on CYP3A4, P-gp, and MATE1\u002F2-K substrates in healthy participants.",[220],"Healthy Volunteers",[222,82,147],"Healthy volunteers","2026-04-29",{"date":225,"type":54},"2026-05-06",{"date":225,"type":21},{"date":228,"type":21},"2026-12-31",{"name":60,"class":61},""]