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AEZS-130 · 1 trial · 1 indication
The primary endpoint for each individual is the peak GH concentration following AEZS-130 (macimorelin) administration.
| Arm | Type | Description |
|---|---|---|
| AEZS-130 ( formerly ARD-07) | EXPERIMENTAL | A single oral administration of AEZS-130 (0.5 mg/kg po) as Growth Hormone Stimulation Test |
| L-ARG+GHRH | ACTIVE_COMPARATOR | This trial was set up as a multi-center, randomized, cross-over study investigating AEZS-130 as a Growth Hormone Stimulation Tests in terms of safety and efficacy compared to L-ARG+GHRH. When GHRH became unavailable on the US market, this comparator arm was no longer available, which was addressed by Amendment No. 3 (version 27-March-2010). Control subject enrolled under Amendment No. 3 were not randomized as there was no cross-over due to unavailability of L-ARG+GHRH. These control subjects received only AEZS-130 |
| Name | Type | Description |
|---|---|---|
| AEZS-130 (formerly ARD-07) | DRUG | A single oral administration of AEZS-130 as Growth Hormone Stimulation Test |
| L-ARG+GHRH | DRUG | A single administration of L-ARG+GHRH (iv bolus) followed by a 30min infusion of L-ARG as Growth Hormone Stimulation Test |
Inclusion for Matched Control Subjects: * Undergone normal growth and development * Normal serum prolactin (PRL) concentrations * Females should have a history of regular, age-appropriate menses * Males should have normal serum testosterone concentrations * Matched GHD subject already enrolled in s...
AEZS-130 is used for the diagnosis of Adult Growth Hormone Deficiency (AGDH). It is an oral small molecule being developed as a growth hormone stimulation test to help diagnose this condition in adults.
AEZS-130 is a growth hormone secretagogue, which means it stimulates the release of growth hormone. It is used as a diagnostic agent to test for Adult Growth Hormone Deficiency (AGDH) by provoking a growth hormone response.
AEZS-130 is being developed by COSCIENS Biopharma Inc., a company traded under the ticker CSCI. The drug is an investigational small molecule intended for use in diagnosing Adult Growth Hormone Deficiency.
AEZS-130 is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. It is being studied for its use in diagnosing Adult Growth Hormone Deficiency (AGDH).
AEZS-130 has one completed Phase 3 clinical trial, identified as NCT00448747. This trial investigated the drug as an oral growth hormone secretagogue for use as a growth hormone stimulation test in diagnosing Adult Growth Hormone Deficiency. The trial enrolled 101 participants in the United States.
AEZS-130 is also known as macimorelin. It is an orally administered growth hormone secretagogue being developed for the diagnosis of Adult Growth Hormone Deficiency (AGDH). The drug is currently in Phase 3 clinical development.