In a phase III randomized trial in 188 patients with acute ischemic stroke, adding EGF plus GHRP-6 to standard care did not improve the primary effectiveness endpoints overall. However, in the 27 patients with severe stroke (NIHSS≥15), the combination was linked to less disability and a lower mortality risk by 6 months. These subgroup findings were exploratory because the overall trial missed its primary endpoint.
Late-phase clinical trial — Phase III open-label randomized multicenter trial. Population: Patients with acute ischemic stroke within 12 hours of symptom onset, NIHSS 5-20. Sample size: 188 patients (95 combined therapy, 93 standard care). Follow-up: 3 and 6 months. Interventions: EGF plus GHRP-6, twice daily for 7 days.
In the intention-to-treat population, there were no differences in mRS, Barthel index, or survival between EGF+GHRP-6 and standard care. In severe-stroke patients (NIHSS≥15, n=27), treatment was associated with lower 6-month disability (mRS 2.6 vs 4.7; p=0.03) and lower mortality risk (HR=0.18; 95%CI 0.03-0.96; p=0.045). In the middle cerebral artery territory, treated patients had greater infarct volume reduction at 30 days (p=0.041), and similar outcomes were seen with an NIHSS≥12 threshold. Severe adverse events occurred in 48/188 patients (30/95 treated; OR=1.92; 95%CI 0.981-3.767), none judged treatment-related.
This is a phase III RCT of GHRP-6 combined with EGF in acute ischemic stroke, so it is directly relevant to evaluating GHRP-6's neuroprotective potential in a clinical population. It suggests possible benefit in moderate-to-severe stroke but does not establish efficacy for unselected acute ischemic stroke, nor does it provide dosing recommendations. Further studies targeting the severe-stroke subpopulation are needed.
Peptide profiles: GHRP-6.
All indexed evidence: GHRP-6 trials & papers.