Study record · Ipamorelin
Ipamorelin for postoperative ileus after bowel resection
Median time was 25.3 hours with ipamorelin versus 32.6 hours placebo; difference was not statistically significant (P=0.15). Key and secondary efficacy.
Key result
Median time was 25.3 hours with ipamorelin versus 32.6 hours placebo; difference was not statistically significant (P=0.15). Key and secondary efficacy analyses were not significant.
Study details
Study designMulticenter, randomized, double-blind, placebo-controlled proof-of-concept trial
PhasePhase II
PopulationAdults undergoing small or large bowel resection
Sample size117 enrolled; 114 safety/mITT
RouteIntravenous
Regimen / exposure0.03 mg/kg twice daily from postoperative day 1 through day 7 or discharge
DurationUp to 7 days
ComparatorPlacebo
Primary endpoint / questionTime from first dose to tolerance of a standardized solid meal
Safety resultAny treatment-emergent adverse event occurred in 87.5% versus 94.8% placebo; FDA later cited serious adverse events including death in the IV clinical programme.
Key limitationsPost-surgical inpatient population and IV route; cannot be extrapolated to subcutaneous wellness/bodybuilding use.
Registry / identifierPMID 25331030 / NCT00672074