[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Amylyx Pharmaceuticals Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":83},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":17,"phases":4,"briefSummary":18,"conditions":19,"keywords":21,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":45,"locationsCount":48},"100639974","an-expanded-access-protocol-to-provide-avexitide-in-patients-with-post-bariatric-hypoglycemia-100639974",false,"NCT07582874","An Expanded Access Protocol to Provide Avexitide in Patients With Post-Bariatric Hypoglycemia","Patients in this EAP will be eligible in one of two categories (Category A and Category B) as defined below:\n\n* Category A: Individuals who have completed the LUCIDITY trial through the Week 48 OLE Part B end-of-treatment visit on avexitide.\n* Category B: Individuals who participated in previous avexitide clinical trials conducted in PBH following RYGB; or documented LUCIDITY participants who signed ICF and were eligible for LUCIDITY based on screening and run-in, but were unable to be randomized due to completion of recruitment.\n\nKey Inclusion Criteria:\n\nApplicable to all patients:\n\n* Male or female, at least 18 years of age; able to understand the purpose and risks of the program, and provides written informed consent to participate.\n* Not eligible for or otherwise able to obtain access to avexitide via a clinical trial, and does not have access to satisfactory, alternative treatment options.\n* If female, cannot be breastfeeding or lactating, and if of childbearing potential must agree to use a highly effective method of birth control during EAP participation. A negative urine pregnancy test is required at time of entry.\n* If male, must agree to use a highly effective method of birth control during EAP participation.\n\nFor Category A:\n\n* Have completed the LUCIDITY trial through the Week 48 OLE Part B end-of-treatment visit on avexitide.\n\nFor Category B:\n\n* Have clinical diagnosis of PBH, and underwent documented RYGB ≥ 12 months prior to EAP eligibility assessment.\n* Has body mass index (BMI) of up to 40 kg\u002Fm2.\n* Treating physician confirmation of either participation in previous avexitide clinical trials conducted in PBH following RYGB; or documented LUCIDITY participant who signed ICF and was eligible for LUCIDITY based on screening and run-in, but was unable to be randomized due to completion of recruitment.\n\nKey Exclusion Criteria:\n\nApplicable to all patients:\n\n* Use of GLP-1 receptor agonists, glucose-dependent insulinotropic polypeptide (GIP)\u002FGLP-1 receptor dual agonists, and other GLP-1 receptor agonist combination therapies.\n* Presence of any clinically relevant condition which, per the judgment of the treating physician, may preclude the patient from safe treatment.\n\nFor Category B:\n\n* Have received another investigational drug for any indication within 5 half-lives of that drug or have participated in another interventional clinical study within 30 days prior to entry visit.\n* History of upper GI surgery affecting RYGB anatomy or function, other than RYGB.\n* Any known or suspected allergy to the investigational medicinal product (avexitide) or any related product (e.g., exenatide).\n* Abnormal liver function defined as AST and\u002For ALT \\> 5 times the upper limit of the normal and\u002For bilirubin level \\>3 times the upper limit of the normal within 12 weeks from entry.\n* Renal impairment, defined as an estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2 within 12 weeks from entry.\n* History or presence of insulinoma or other cause of endogenous hyperinsulinism other than PBH.\n* Presence of acute or chronic pancreatitis, history of idiopathic acute pancreatitis, or pancreatic cancer.","ALL","18 Years","EXPANDED_ACCESS","The Expanded Access Program will provide access to avexitide for people with post-bariatric hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) who meet the eligibility criteria for this program. The safety of avexitide and patient treatment experience will be monitored during this program.",[20],"Post-bariatric Hypoglycemia",[22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"AVX","avexitide","PBH","post-bariatric hypoglycemia","hypoglycemia post bariatric surgery","reactive hypoglycemia","hypoglycemia","low blood sugar","Roux-en-Y gastric bypass (RYGB)","Roux-en-Y gastric bypass","Roux-en-Y","RYGB","gastric bypass","LUCIDITY","PREVENT","exendin","exendin 9-39","exendin 939","AVAILABLE","2026-05-05",{"date":43,"type":44},"2026-05-13","ACTUAL",{"name":46,"class":47},"Amylyx Pharmaceuticals Inc.","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":66,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},"100567206","phase-1-amx0114-in-adult-participants-with-amyotrophic-lateral-sclerosis-100567206","NCT06665165","AMX0114 in Adult Participants With Amyotrophic Lateral Sclerosis","Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study to Evaluate Safety, Tolerability, PK and PD of Antisense Oligonucleotide AMX0114 Administered to Adult Participants With Amyotrophic Lateral Sclerosis","LUMINA","Inclusion Criteria:\n\n1. Ability to understand the purpose and risks of this study, willingness to comply with the study and to provide informed consent in accordance with local laws and regulations.\n2. Male or female, at least 18 years of age.\n3. Diagnosis of clinically definite or clinically probable ALS, made by a physician who is experienced with management of ALS.\n4. Time since onset of first symptom of ALS should be \\\u003C24 months prior to beginning the study. Date of ALS symptom onset is defined as the onset of weakness (in the limbs, bulbar region, or trunk).\n5. If the participant is to be treated with riluzole and\u002For edaravone before or during the trial, then treatment must be previously started and maintained at a stable regimen for at least 30 days prior to starting the study and through the end of the study.\n6. Women of childbearing potential (e.g., not post-menopausal for at least one year or surgically sterile) must agree to use an acceptable birth control method for the duration of the trial and 60 days after the last dose of Study Drug or be of non-childbearing potential.\n7. Female participants or female partners of male participants must not be pregnant or plan to become pregnant for the duration of the trial and for up to 90 days after the last dose of Study Drug.\n8. Male participants must agree to abstain from sperm donation for the duration of the trial and practice contraception with a female partner, for at least 90 days after last dose of Study Drug.\n\nExclusion Criteria:\n\n1. Presence of tracheostomy or permanent assisted ventilation.\n2. SVC less than 65%.\n3. Abnormal liver function defined as aspartate aminotransferase and\u002For alanine aminotransferase \\> 3 times the upper limit of normal (ULN) and\u002For total bilirubin \\> 1.5 times the ULN (obtained within 4 weeks of first dose) except when a result of Gilbert syndrome.\n4. Abnormal renal function defined as estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73m2.\n5. Other laboratory abnormalities, including abnormalities in platelet count, international normalized ratio, prothrombin time, and activated partial thromboplastin time.\n6. Pregnant women (confirmed by a pregnancy test within 7 days prior to first dose) or women currently breastfeeding.\n7. Current or previous clinically significant, unstable medical condition (other than ALS), that in the opinion of the Investigator could affect a participant's safety or ability to comply with the study.\n8. Significant abnormalities in physical\u002Fneurological examination, vital signs, or electrocardiogram (ECG), which in the opinion of the Investigator could affect the safety of the participant.\n9. Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that could affect the participant's ability to provide informed consent or comply with study procedures.\n10. Current or previous enrollment in another trial involving use of an investigational therapy, in most cases within 30 days after the last dose of the study drug, prior to starting this study.\n11. Current or previous treatment with small interfering ribonucleic acid, stem cell therapy, any ASO or gene therapy.\n12. Any contraindications for lumbar puncture or repeated intrathecal injection and\u002For underlying disorders that could be affected by intrathecal injections.\n13. Prior severe reaction or known hypersensitivity to any part of the Study Drug.",{"count":58,"type":59},48,"ESTIMATED","INTERVENTIONAL",[62],"PHASE1","This study is a placebo-controlled Phase I study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of the antisense oligonucleotide (ASO) AMX0114 in adult participants with amyotrophic lateral sclerosis (ALS).",[65],"ALS",[67,68,69,70,71,72],"Amyotrophic Lateral Sclerosis","Sporadic ALS","Motor Neuron Disease","Antisense oligonucleotide","ASO","Calpain-2","RECRUITING","2026-04-09",{"date":76,"type":44},"2026-04-14",{"date":78,"type":44},"2025-04-07",{"date":80,"type":59},"2027-10",{"name":46,"class":47},14,""]