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| Name | Class |
|---|---|
| Larix A/S | INDUSTRY |
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A proof-of-concept, dose finding, controlled, single-center, randomized, double-blind, fixed dose phase 2 trial with ZP1848 in patients with Short Bowel Syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ZP1848 High dose | Experimental | s.c. administration of high dose |
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| ZP1848 Medium dose | Experimental | s.c. administration of medium dose |
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| ZP1848 Low dose | Experimental | s.c. administration of low dose |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ZP1848 | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Primary endpoint is the absolute change from baseline to the end of three week treatment periods of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Relative change from baseline to the end of treatment of wet weight of ostomy output or diarrhea measured separately over each of the two treatment periods | 3 weeks | |
| Absolute change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gertrud Koefoed Rasmussen, MSc | Zealand Pharma A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet | Copenhagen | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34287979 | Derived | Hvistendahl MK, Naimi RM, Hansen SH, Rehfeld JF, Kissow H, Pedersen J, Dragsted LO, Sonne DP, Knop FK, Jeppesen PB. Bile acid-farnesoid X receptor-fibroblast growth factor 19 axis in patients with short bowel syndrome: The randomized, glepaglutide phase 2 trial. JPEN J Parenter Enteral Nutr. 2022 May;46(4):923-935. doi: 10.1002/jpen.2224. Epub 2021 Sep 1. | |
| 31326433 |
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| ID | Term |
|---|---|
| D012778 | Short Bowel Syndrome |
| ID | Term |
|---|---|
| D008286 | Malabsorption Syndromes |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 3 weeks |
| Relative change from baseline to the end of treatment of urine weight measured separately over each of the two treatment periods | 3 weeks |
| Absolute change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods | 3 weeks |
| Relative change from baseline to the end of treatment of wet weight absorption measured separately over each of the two treatment periods | 3 weeks |
| Absolute change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods | 3 weeks |
| Relative change from baseline to the end of treatment of the intestinal absorption of electrolytes measured separately over each of the two treatment periods | 3 weeks |
| Absolute change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods | 3 weeks |
| Relative change from baseline to the end of treatment of the intestinal absorption of macronutrients measured separately over each of the two treatment periods | 3 weeks |
| Change in SF-36 score | 3 weeks |
| Incidence of Adverse Events | 15 weeks |
| Incidence of Anti Drug Antibodies | 15 weeks |
| Absolute change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods | 3 weeks |
| Relative change from baseline to the end of treatment of urine weight minus oral intake measured separately over each of the two treatment periods | 3 weeks |
| Naimi RM, Hvistendahl M, Nerup N, Ambrus R, Achiam MP, Svendsen LB, Gronbaek H, Moller HJ, Vilstrup H, Steensberg A, Jeppesen PB. Effects of glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, on markers of liver status in patients with short bowel syndrome: findings from a randomised phase 2 trial. EBioMedicine. 2019 Aug;46:444-451. doi: 10.1016/j.ebiom.2019.07.016. Epub 2019 Jul 17. |
| 30880176 | Derived | Naimi RM, Hvistendahl M, Enevoldsen LH, Madsen JL, Fuglsang S, Poulsen SS, Kissow H, Pedersen J, Nerup N, Ambrus R, Achiam MP, Svendsen LB, Holst JJ, Hartmann B, Hansen SH, Dragsted LO, Steensberg A, Mouritzen U, Hansen MB, Jeppesen PB. Glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, for patients with short bowel syndrome: a randomised phase 2 trial. Lancet Gastroenterol Hepatol. 2019 May;4(5):354-363. doi: 10.1016/S2468-1253(19)30077-9. Epub 2019 Mar 15. |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |