Aeterna Zentaris Inc. (AEZS, AEZ.TO) said that final Phase 3 results for its oral ghrelin agonist, AEZS-130, show that the drug is safe and effective in diagnosing adult growth hormone deficiency, or AGHD.
The multicenter open label study was originally designed as a cross-over trial of AEZS-130 vs growth hormone-releasing hormone (GHRH)+L-Arginine (ARG) in AGHD patients and in controls, matched for body mass index, estrogen status, gender and age. After 43 AGHD patients and 10 controls had been tested, GHRH became unavailable. The study was completed by testing 10 more AGHD patients and 38 controls with AEZS-130 alone.
The objective of the clinical trial was to determine the efficacy and safety of AEZS-130 in the diagnosis of AGHD.
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