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• W2922431383 abstract "Introduction: In two Phase 2 trials of relamorelin (RLM), a ghrelin receptor agonist, results showed acceleration of gastric emptying and suggested symptom improvement in diabetic gastroparesis (DG) patients. Study participants maintained their usual diabetic regimen, although intensive glycemic monitoring was not required. This study assessed the safety and tolerability of RLM in the Phase 2 trials.1206_A Figure 1. Summary of treatment—emergent adverse events in the relamorelin Phase 2a and 2b trialsMethods: Randomized, double—blind, placebo—controlled Phase 2 trials (NCT01571297, NCT02357420; results published previously) were conducted in DG patients aged 18—75 years over 4 weeks (subcutaneous [SC] RLM 10ug once or twice daily [BID] or placebo BID) and 12 weeks (SC RLM 10, 30, or 100ug or placebo BID) with 1— and 2—week, single—blind placebo run—ins, respectively. Safety assessments included weight, adverse events (AEs), and laboratory tests, including blood glucose and HbA1c measurements. Analysis of covariance on change from baseline (CFB) values assessed RLM effect on HbA1c and glucose post hoc; a linear trend test was also performed. All other data are descriptive. Results: Of 204 Phase 2a and 393 Phase 2b patients, mean age was 56 years, 36% were male, 90% had type 2 diabetes, and mean (range) BMI was 32 (18—60) kg/m2. Proportions of patients with ≥1 treatment—emergent AE (TEAE) were largely similar across treatment groups (Table, TEAEs in ≥5% of RLM—treated patients). No cardiac TEAE occurred in ≥2% of any RLM—treated group. In Phase 2b, discontinuation due to TEAEs was higher in RLM groups than placebo. Serious TEAE incidence was broadly similar across groups. No specific serious TEAE occurred in ≥1 Phase 2a patient; 1 developed diabetic ketoacidosis (DKA) during the placebo run—in period (not treatment emergent). In Phase 2b, 2 patients on RLM 30ug had unstable angina,1 on RLM 100ug died from urosepsis, and 3 developed DKA, all unrelated to RLM. CFB to Week 12 HbA1c levels (%) in Phase 2b increased with RLM dose: mean (SD) values were —0.03 (0.86), 0.48 (1.03), 0.92 (1.53), and 0.81 (1.77) for placebo, RLM 10, 30, and 100ug, respectively (linear trend test p<0.0001). There was a dose—related linear trend in fasting blood glucose (p=0.0043). Conclusion: Phase 2 results indicate that RLM 10—100ug BID is generally safe and well tolerated in adults with DG, although ghrelin agonists may stimulate hyperglycemia. Planned Phase 3 trials will study the 10ug BID dose only and will involve proactive glycemic management due to elevated blood glucose observed in RLM—treated patients.1206_B Figure 2. Summary of treatment—emergent adverse events in the relamorelin Phase 2a and 2b trials" @default.
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• W2922431383 date "2018-10-01" @default.
• W2922431383 modified "2023-09-23" @default.
• W2922431383 title "Overall Safety and Tolerability of Relamorelin in Adults With Diabetic Gastroparesis: Analysis of Phase 2a and Phase 2b Trial Data" @default.
• W2922431383 doi "https://doi.org/10.14309/00000434-201810001-01206" @default.
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