[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Neuvosyn Laboratories, LLC\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":41},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100650325","phase-3-an-open-label-single-arm-study-to-investigate-the-efficacy-and-safety-of-north-star-desiccated-porcine-thyroid-extract-tablets-100650325",false,"NCT07747103","An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets.","An Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of North Star Desiccated Porcine Thyroid Extract Tablets for the Treatment of Primary Hypothyroidism","Inclusion Criteria:\n\n* Diagnosed with primary hypothyroidism, including Hashimoto's Thyroiditis, and on therapy with a stable dose of LT4 (minimum 50 mcg per day, administered 7 days per week) for at least 12 weeks prior to Screening\n* Have had euthyroid status for at least 6 weeks and up to 12 months prior to Screening (Visit 1), with at least one documented minimum stable dose of 50 mcg LT4.\n* Agree to practice a method of contraception\n* Female patients not pregnant or lactating at Screening\n* Agree to practice a method of contraception of greater than 90% reliability\n* Willing to give written informed consent for the Study\n* Provide written authorization for use and disclosure of protected health information\n\nExclusion Criteria:\n\n* Any clinical condition or previous surgery that might affect the absorption, distribution, biotransformation or excretion of North Star\n* Hospitalization for a major illness within 5 weeks prior to Screening\n* Concomitant use of prohibited medications or supplements\n* Have uncontrolled diabetes\n* Taking or having taken prescription or over-the-counter weight loss medications within 6 weeks prior to Screening\n* Participated in another investigational new drug study within 30 days or 5 half-lives of the IMP, whichever is longer, prior to the first study drug administration.\n* For female subjects, be pregnant, nursing or planning to become pregnant during the study","ALL","18 Years","75 Years",{"count":20,"type":21},466,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The North Star study is a multi-center, Phase 3, open-label, single-arm clinical study to evaluate the Efficacy and Safety of North Star therapy.",[27],"Hypothyroidism","RECRUITING","2026-07-30",{"date":31,"type":32},"2026-08-05","ACTUAL",{"date":34,"type":32},"2026-06-30",{"date":36,"type":21},"2027-12",{"name":38,"class":39},"Neuvosyn Laboratories, LLC","INDUSTRY",25,""]