Oral administration of the growth hormone secretagogue NN703 in adult patients with growth hormone deficiency

Summary objective Little is known of the usefulness of GH secretagogues (GHSs) in GH-deficient (GHD) adults. The objective of this study was to determine the number of responders to treatment with NN703 in GHD adults. design A multicentre, randomized, double-blind, and placebo-controlled study. patients Ninety-seven GHD adults were included. measurements The GH response before and after 1 week of oral treatment with NN703 (n = 83) or placebo (n = 14) was determined. The first and last dose of NN703 was 3 mg/kg, whereas the dose of NN703 was 1·5 mg/kg/day during the 6 days between the first and last doses. Furthermore, all 97 patients received 1 µg/kg GH-releasing hormone (GHRH) 3 weeks after the last dose of NN703. results Serum GH peak and area under curve (AUC) values after the first NN703 administration were greater than those after placebo administration (P < 0·05). However, after correction for the lower body mass index (BMI) in the NN703 group, this difference lost statistical significance. After 1 week of therapy, GH peak and AUC values were similar following the final doses of NN703 and placebo. Serum peak and AUC values of other anterior pituitary hormones were similar between the NN703 and placebo groups both after the first and last administration of study drug. Nine of the 83 patients (11%) responded with a serum peak GH concentration ≥ 5 µg/l after the first and/or last NN703 administration, whereas no patient responded after placebo administration. Serum IGF-I was unaffected by 1-week NN703 treatment, whereas serum IGFBP-3 was increased (P