[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Biomed Industries, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":76},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100580684","phase-3-to-investigate-the-efficacy-of-treatment-with-oral-na-921-bionetide-versus-placebo-in-females-with-rett-syndrome-100580684",false,"NCT06840496","To Investigate the Efficacy of Treatment With Oral NA-921 (Bionetide) Versus Placebo in Females With Rett Syndrome","A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Bionetide for the Treatment of Girls and Women With Rett Syndrome","INCLUSION CRITERIA\n\n1. Female subjects 5 to 20 years of age, inclusive, at Screening\n2. Body weight ≥12 kg at Screening\n3. Can swallow the study medication provided as a liquid solution or can take it by gastrostomy tube\n4. Has classic\u002Ftypical Rett syndrome (RTT)\n5. Has a documented disease-causing mutation in the MECP2 gene\n6. Has a stable pattern of seizures, or has had no seizures, within 8 weeks of Screening\n7. Subjects of childbearing potential must abstain from sexual activity for the duration of the study and for at least 30 days thereafter or must agree to use acceptable methods of contraception. Subject must not be pregnant or breastfeeding.\n8. The subject's caregiver is English-speaking and has sufficient language skills to complete the caregiver assessments\n9. Subject and caregiver(s) must reside at a location to which study drug can be delivered and have been at their present residence for at least 3 months prior to Screening\n\nEXCLUSION CRITERIA\n\n1. Has been treated with insulin within 12 weeks of Baseline\n2. Has current clinically significant cardiovascular, endocrine (such as hypo- or hyperthyroidism, Type 1 diabetes mellitus, or uncontrolled Type 2 diabetes mellitus), renal, hepatic, respiratory or gastrointestinal disease (such as celiac disease or inflammatory bowel disease) or has major surgery planned during the study\n3. Has a history of, or current, cerebrovascular disease or brain trauma\n4. Has significant, uncorrected visual or uncorrected hearing impairment\n5. Has a history of, or current, malignancy\n6. Has a known history or symptoms of long QT syndrome","FEMALE","5 Years","20 Years",{"count":20,"type":21},210,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","Primary Objective • To investigate the efficacy of treatment with oral Bionetide versus placebo in girls and women with Rett syndrome\n\nKey Secondary Objective\n\n• To investigate the efficacy of treatment with oral Bionetide versus placebo on ability to communicate in girls and women with Rett syndrome",[27],"Rett Syndrome",[29,30],"Rett syndrome,","Genetic Diseases, X-Linked","RECRUITING","2026-03-24",{"date":34,"type":35},"2026-03-27","ACTUAL",{"date":37,"type":21},"2026-09-30",{"date":39,"type":21},"2027-12-30",{"name":41,"class":42},"Biomed Industries, Inc.","INDUSTRY",18,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":69,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100572359","phase-2-safety-and-efficacy-of-na-931-and-tirzepatide-in-adults-who-are-overweight-or-obese-100572359","NCT06732245","Safety and Efficacy of NA-931 and Tirzepatide in Adults Who Are Overweight or Obese","A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Oral NA-931, Alone or in Addition to Open Label Subcutaneous Tirzepatide , to Investigate the Efficacy and Safety in Overweight or Obese Men and Women","Inclusion Criteria:\n\n* A written informed consent must be obtained before any study-related assessments are performed.\n* Men and women between 18 and 80 years, inclusive; women of child-bearing potential (defined as those who are not post-menopausal or post-surgical sterilization) must meet both of the following criteria:\n\n  * Two negative pregnancy tests (at screening and at randomization, prior to dosing)\n  * Use of intrauterine device, from at least 3 months before the baseline visit through at least 4 months after the last dose of NA-931\u002Fplacebo oral, and an additional contraceptive (barrier) method from screening through at least 4 months after the last dose of NA-931\u002Fplacebo oral.\n* Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia)\n* Stable body weight (± 5 kg) within 90 days of screening, and body weight \\\u003C150 kg\n* Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight\n* Able to communicate well with the Investigator, comply with the study requirements and adhere to the diet and activity programs for the study duration\n\nExclusion Criteria:\n\n* • History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to Tirzepatide (Zepbound® or Mounjaro®)\n\n  * Use of other investigational drugs at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer, or longer if required by local regulations\n  * Treatment with any medication for the indication of obesity within the past 30 days before screening\n  * Diagnosis of diabetes requiring current use of any antidiabetic drug or HbA1c ≥ 6.5% Note: Metabolic syndrome is not an exclusion, even if managed with an anti-diabetic drug such as metformin or an SGLT2 inhibitor. A diagnosis of prediabetes or impaired glucose tolerance managed exclusively with non-pharmacologic approaches (e.g., diet and exercise) is not an exclusion.\n  * Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV). History of hepatitis A or hepatitis C successfully treated is not exclusionary. Active COVID-19 infection.\n  * Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation, or plasma donation (\\> 250 mL) within 14 days prior to the first dose\n  * Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol","ALL","19 Years","80 Years",{"count":55,"type":21},224,[57],"PHASE2","A phase 2 study to assess the efficacy of NA-931 alone or in addition to Tirzepatide to assess efficacy and safety in overweight or obese men and women",[60],"Obesity and Overweight",[62,63,64,65,66,67],"NA-931","Obesity","Biomed Industries, Inc","overweight","Tirzepatide","Zepbound","NOT_YET_RECRUITING",{"date":34,"type":35},{"date":71,"type":21},"2026-08-15",{"date":73,"type":21},"2027-12-15",{"name":41,"class":42},17,""]