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- Title
A phase 2a, randomized, double-blind 28-day study of TZP-102 a ghrelin receptor agonist for diabetic gastroparesis.
- Authors
Ejskjaer, N.; Wo, J. M.; Esfandyari, T.; Mazen Jamal, M.; Dimcevski, G.; Tarnow, L.; Malik, R. A.; Hellström, P. M.; Mondou, E.; Quinn, J.; Rousseau, F.; McCallum, R. W.
- Abstract
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 ( T½) 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 T½ changes were not statistically significant between TZP-102 and placebo after 28 days 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 1 week 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 28 days, at doses of 10-40 mg 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.
- Subjects
GASTROPARESIS; SYMPTOMS; GASTRIC emptying; GASTROINTESTINAL diseases; PHYSICIANS
- Publication
Neurogastroenterology & Motility, 2013, Vol 25, Issue 2, pe140
- ISSN
1350-1925
- Publication type
Article
- DOI
10.1111/nmo.12064