Study to Evaluate Efficacy and Safety of BGE-117 in the Treatment of Unexplained Anemia of Aging (UAA)

Summary

Participation Requirements

Description

This is a randomized, placebo-controlled, multicenter, double- blind study of BGE-117 administered PO in participants ? 65 years of age for the treatment of unexplained anemia in aging (UAA). UAA is a diagnosis of anemia where a definitive cause for the anemia cannot be found despite standard invest...

This is a randomized, placebo-controlled, multicenter, double- blind study of BGE-117 administered PO in participants ? 65 years of age for the treatment of unexplained anemia in aging (UAA). UAA is a diagnosis of anemia where a definitive cause for the anemia cannot be found despite standard investigations. This study's planned size is 160 evaluable subjects (80 subjects randomized to BGE-117 and 80 subjects randomized to placebo). After signing informed consent, participants will be screened for study eligibility. Screening will include full physical examination, vital signs, safety and study-related laboratory evaluation, ophthalmic exam, ECG, vascular doppler ultrasound, and clinical outcome assessment. Two-screening visits are required at least 7 days apart for laboratory assessments. If confirmed that the participant qualifies for this protocol according to listed inclusion and exclusion criteria, participants will be randomized to BGE-117 or placebo, PO, once per day, for a treatment period duration of approximately 12 weeks. Dose adjustments for study medication during the treatment period are made according to a dosing algorithm to achieve and maintain hemoglobin (Hb) within the target range (12.0-13.0 g/dL). Study procedures and assessments are performed at various timepoints during the treatment period per the schedule outlined in the study protocol. Participants will undergo follow-up assessments for approximately 4 weeks after administration of the last dose.

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