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A phase 2a, randomi...
A phase 2a, randomized, double-blind 28-day study of TZP-102 a ghrelin receptor agonist for diabetic gastroparesis
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Ejskjaer, N. (author)
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Wo, J. M. (author)
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Esfandyari, T. (author)
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Mazen Jamal, M. (author)
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Dimcevski, G. (author)
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Tarnow, L. (author)
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Malik, R. A. (author)
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- Hellström, Per M. (author)
- Uppsala universitet,Gastroenterologi/hepatologi
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Mondou, E. (author)
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Quinn, J. (author)
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Rousseau, F. (author)
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Mccallum, R. W. (author)
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(creator_code:org_t)
- 2012-12-23
- 2013
- English.
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In: Neurogastroenterology and Motility. - : Wiley. - 1350-1925 .- 1365-2982. ; 25:2, s. e140-e150
- Related links:
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https://urn.kb.se/re...
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https://doi.org/10.1...
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Abstract
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- Background Gastroparesis causes significant morbidity and treatment options are limited. TZP-102 a novel, macrocyclic, selective, oral ghrelin receptor agonist, was evaluated in a randomized, double-blind, placebo-controlled trial in patients with diabetic gastroparesis. Methods A total of 92 outpatients were randomized to once-daily administrations of 10-mg (n=22), 20-mg (n=21), 40-mg (n=23) TZP-102 or placebo (n=26). The primary endpoint was the change from baseline in gastric half-emptying time (T1/2) utilizing 13C-breath test methodology and secondary endpoints included symptom improvement using patient-reported gastroparesis symptom scores (PAGI-SYM questionnaire) and patient and physician overall treatment evaluations (OTE). Key Results Gastric T1/2 changes were not statistically significant between TZP-102 and placebo after 28days of treatment at any dose. Clinical improvements (-1.0 to -1.4 point mean decrease in symptom severity) occurred in the Gastroparesis Cardinal Symptom Index (GCSI) component of the PAGI-SYM, which was significant vs placebo for all TZP-102 doses combined. Improvements became evident after 1week of treatment. Significantly, more patients given TZP-102 (any dose) had a 50% reduction in baseline GCSI score (28.8%vs 7.7% placebo). Safety profiles were similar across groups. All TZP-102 doses were well-tolerated with no adverse cardiac, weight, or glucose control outcomes. Conclusions & Inferences TZP-102 for 28days, at doses of 10-40mg once daily, was well-tolerated and resulted in a reduction in symptoms of gastroparesis. The lack of correlation between symptom improvement and gastric emptying change is consistent with previous studies in diabetic gastroparesis, and emphasizes the value of patient-defined outcomes in determining therapeutic benefit.
Keyword
- Diabetes type 1
- Diabetes type 2
- Diabetic gastroparesis
- Gastroparesis
- Oral ghrelin receptor agonist
Publication and Content Type
- ref (subject category)
- art (subject category)
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- By the author/editor
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Ejskjaer, N.
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Wo, J. M.
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Esfandyari, T.
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Mazen Jamal, M.
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Dimcevski, G.
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Tarnow, L.
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show more...
-
Malik, R. A.
-
Hellström, Per M ...
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Mondou, E.
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Quinn, J.
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Rousseau, F.
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Mccallum, R. W.
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show less...
- Articles in the publication
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Neurogastroenter ...
- By the university
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Uppsala University