madman
Super Moderator
Objective
To compare GH responses to an oral GH secretagogue, LUM-201 (ibutamoren, formerly MK-0677) and standard GH stimulation tests used for diagnosis of pediatric growth hormone deficiency (PGHD)
Introduction
LUM-201 is an orally administered agonist of the growth hormone secretagogue receptor (GHSR1a). A clinical study is underway (NCT04614337) to determine if LUM-201 is a safe and effective alternative to injections of recombinant human growth hormone (rhGH) in PGHD.
LUM-201 is an agonist of the growth hormone secretagogue receptor (GHSR1a) in the hypothalamus that diminishes inhibitory signals via somatostatin and increases stimulatory signals via GHRH to augment endogenous GH pulsatility (Fig 1).
Methods
• GH responses measured to a single, oral 0.8 mg/kg dose of LUM-201 and to two standard GH stimulation tests (arginine, clonidine, glucagon, insulin, L-Dopa)
• 68 subjects (40 M, 28 F) had GH responses measured to a single, oral 0.8 mg/kg dose of LUM-201 and to two standard GH stimulation tests (arginine, clonidine, glucagon, insulin, L-Dopa)
• Median (interquartile range) values for patient characteristics are shown in Table 1
Summary and Conclusions
In prepubertal subjects diagnosed with Pediatric Growth Hormone Deficiency
- GH responses to single, oral doses of LUM-201 are substantially higher than observed in two standard GH stimulation tests.
- The difference in GH responses increases with higher baseline concentrations of IGF-I and higher GH stimulation test results.
- A differential response between LUM-201 and standard GH stimulation tests are more likely in patients with more moderate forms of PGHD
To compare GH responses to an oral GH secretagogue, LUM-201 (ibutamoren, formerly MK-0677) and standard GH stimulation tests used for diagnosis of pediatric growth hormone deficiency (PGHD)
Introduction
LUM-201 is an orally administered agonist of the growth hormone secretagogue receptor (GHSR1a). A clinical study is underway (NCT04614337) to determine if LUM-201 is a safe and effective alternative to injections of recombinant human growth hormone (rhGH) in PGHD.
LUM-201 is an agonist of the growth hormone secretagogue receptor (GHSR1a) in the hypothalamus that diminishes inhibitory signals via somatostatin and increases stimulatory signals via GHRH to augment endogenous GH pulsatility (Fig 1).
Methods
• GH responses measured to a single, oral 0.8 mg/kg dose of LUM-201 and to two standard GH stimulation tests (arginine, clonidine, glucagon, insulin, L-Dopa)
• 68 subjects (40 M, 28 F) had GH responses measured to a single, oral 0.8 mg/kg dose of LUM-201 and to two standard GH stimulation tests (arginine, clonidine, glucagon, insulin, L-Dopa)
• Median (interquartile range) values for patient characteristics are shown in Table 1
Summary and Conclusions
In prepubertal subjects diagnosed with Pediatric Growth Hormone Deficiency
- GH responses to single, oral doses of LUM-201 are substantially higher than observed in two standard GH stimulation tests.
- The difference in GH responses increases with higher baseline concentrations of IGF-I and higher GH stimulation test results.
- A differential response between LUM-201 and standard GH stimulation tests are more likely in patients with more moderate forms of PGHD
