Overall safety of relamorelin in adults with diabetic gastroparesis: Analysis of phase 2a and 2b trial data

Michael Camilleri, Anthony Lembo, Richard McCallum, Stavros Tourkodimitris, Lara Kemps, Matthew B. Miller, Kirk Bertelsen, Alexandru Iacob

Research output: Contribution to journalArticle

Abstract

Background: Relamorelin, a pentapeptide ghrelin receptor agonist, accelerated gastric emptying significantly and improved symptoms in adults with diabetic gastroparesis in phase 2 trials. Aim: To assess the safety and tolerability of relamorelin across phase 2 trials. Methods: Safety assessments in patients aged 18-75 years (weight, adverse events [AEs] and laboratory tests) from two randomised, double-blind phase 2 trials (NCT01571297, NCT02357420; results published previously) were reviewed descriptively. Analysis of covariance assessed treatment effect on glycated haemoglobin (HbA1c) and blood glucose post hoc. Phase 2a and 2b trial durations were, respectively, 4 weeks (relamorelin 10 µg once or twice daily [b.d.] or placebo b.d.) and 12 weeks (relamorelin 10, 30 or 100 µg or placebo b.d.) with 1- and 2-week, single-blind placebo run-ins. Results: Among 204 phase 2a and 393 phase 2b patients, respectively, 67% and 62% were female, and 88% and 89% had type 2 diabetes. Proportions of patients reporting serious AEs were similar across treatment groups, as were those with ≥1 treatment-emergent AE (TEAE). TEAE-related discontinuations were proportionally higher in relamorelin groups than placebo. Of 12 serious TEAEs in phase 2a, none occurred in >1 patient. In phase 2b, five serious TEAEs were reported in >1 patient, and one (100 µg) died (urosepsis), all unrelated to relamorelin. In phase 2b, increased HbA1c and fasting blood glucose levels were dose-related (P < 0.0001 and P = 0.0043, respectively). Conclusions: Relamorelin showed acceptable safety and tolerability in phase 2 trials. Relamorelin may elevate blood glucose: this should be managed proactively in relamorelin-treated patients.

Original languageEnglish (US)
Pages (from-to)1139-1148
Number of pages10
JournalAlimentary Pharmacology and Therapeutics
Volume51
Issue number11
DOIs
StatePublished - Jun 1 2020

ASJC Scopus subject areas

  • Hepatology
  • Gastroenterology
  • Pharmacology (medical)

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    Camilleri, M., Lembo, A., McCallum, R., Tourkodimitris, S., Kemps, L., Miller, M. B., Bertelsen, K., & Iacob, A. (2020). Overall safety of relamorelin in adults with diabetic gastroparesis: Analysis of phase 2a and 2b trial data. Alimentary Pharmacology and Therapeutics, 51(11), 1139-1148. https://doi.org/10.1111/apt.15711