[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zealand Pharma\",\"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,[8,51],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100608160","phase-3-efficacy-and-safety-evaluation-of-glepaglutide-in-treatment-of-sbs-100608160",false,"NCT07197944","Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS","A Phase 3, Double-blind, Randomized, Parallel Group, Placebo-controlled, Multicenter Trial to Confirm the Efficacy and Safety of Glepaglutide 10 mg Twice Weekly, Followed by a Long-term, Open-label Safety Evaluation in Patients With Short Bowel Syndrome-intestinal Failure (SBS-IF)","EASE SBS 5","Key Inclusion Criteria:\n\n* Signed informed consent;\n* Age of 18 to 90 years;\n* A diagnosis of SBS, defined as having a small bowel with an estimated length of less than 200 cm (equal to 79 inches) in continuity (latest intestinal resection ≥6 months before screening);\n* Stable PS need of ≥3 days per week;\n* No restorative surgery planned during the trial period;\n* Having a stoma or colon in continuity.\n\nKey Exclusion Criteria:\n\n* More than 2 SBS- or PS-related hospitalizations within 6 months before screening;\n* Poorly controlled Inflammatory Bowel Disease (IBD) that is moderately or severely active or a fistula that can interfere with the measurements or examinations required in the trial;\n* History of colorectal cancer or any other type of cancer (except for margin-free resected cutaneous basal, squamous cell carcinoma or adequately treated in situ cervical cancer) unless the patient has been disease-free for at least 5 years; ongoing bowel obstruction;\n* BMI \\\u003C18.5 kg\u002Fm\\^2.","ALL","18 Years","90 Years",{"count":21,"type":22},90,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The purpose of the present Phase 3 trial is to confirm the efficacy and safety of glepaglutide 10 mg twice weekly in a patient population with SBS-IF and generate additional long-term safety data.\n\nGlepaglutide is the International Nonproprietary Name and United States Adopted Name (USAN) for ZP1848.",[28],"Short Bowel Syndrome",[30,31,32,33,34,35,36,28,37],"Intestinal Failure","Pathologic Processes","Malabsorption Syndromes","Intestinal Diseases","Gastrointestinal Diseases","Digestive System Diseases","Postoperative Complications","Syndrome","RECRUITING","2026-04-17",{"date":41,"type":42},"2026-04-20","ACTUAL",{"date":44,"type":42},"2026-02-11",{"date":46,"type":22},"2032-02-28",{"name":48,"class":49},"Zealand Pharma","INDUSTRY",23,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":58,"sex":17,"minAge":18,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":23,"phases":62,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":75},"100568572","phase-1-a-research-study-looking-at-the-safety-of-single-and-multiple-doses-of-zp9830-and-how-it-works-in-the-body-of-healthy-participants-100568572","NCT06682975","A Research Study Looking at the Safety of Single and Multiple Doses of ZP9830 and How it Works in the Body of Healthy Participants","A First-in-human, Randomized and Double-blind Within Cohorts, Placebo-controlled, Single and Multiple Ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ZP9830 Administered to Healthy Participants.","Inclusion Criteria:\n\n* Healthy participants.\n* 18-45 years of age (inclusive).\n* Body weight ≥50 kg.\n* SAD part B only: Fitzpatrick skin type I-III (Caucasian).\n* C-reactive protein ≤10 mg\u002FL.\n* Further inclusion criteria apply.\n\nExclusion Criteria:\n\n* Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of it might interfere with, the conduct or the interpretation of the results of the trial, or that would pose an unacceptable risk to the subject in the opinion of the Investigator \\[following a detailed medical history, physical examination, vital signs (systolic and diastolic blood pressure, pulse rate, body temperature) and 12-lead ECG\\].\n* Any disease associated with immune system impairment, including immune mediated diseases and transplantation patients.\n* Any confirmed significant allergic reactions (urticaria or anaphylaxis) to insect bites.\n* History of neurological disorders including neuropathy, as judged by the investigator.\n* Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug or food (in particular any level of severity of allergy to shellfish), or multiple drug allergies (non-active hay fever is acceptable).\n* Further exclusion criteria apply.",true,"45 Years",{"count":61,"type":22},124,[63],"PHASE1","The primary object in this research study is to investigate the safety and tolerability of ZP9830 in healthy study participants, and in addition, the study will investigate how ZP9830 works in the body (pharmacokinetics, PK and pharmacodynamics, PD) compared to placebo.",[66],"Healthy Volunteers","2026-02-12",{"date":69,"type":42},"2026-02-17",{"date":71,"type":42},"2024-11-12",{"date":73,"type":22},"2026-08",{"name":48,"class":49},1,""]