NCT04815603

Study to Evaluate Efficacy and Safety of BGE-117 in the Treatment of Anemia of Aging

A Phase 2a, 12-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Efficacy and Safety of BGE-117 in the Treatment of Anemia of Aging

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: BioAge Labs, Inc. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study to evaluate the safety, tolerability and efficacy of BGE-117 in the treatment of anemia of aging in participants ≥ 65 years of age.

Detailed 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 anemia of aging. Anemia of aging accounts for approximately one-third of anemia in patients over 65 years of age, defined as a suboptimal hemoglobin level due to different underlying characteristics. 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 may be Pre-screened for hemoglobin using HemoCue, and subsequently will be screened for study eligibility. Screening will include full physical examination, vital signs, safety and study-related laboratory evaluation, ophthalmic exam, ECG, Wells score for DVT, and clinical outcome assessment. 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 (12.5-13.0 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.

Conditions

• Anemia

Interventions

Type	Name	Description
DRUG	BGE-117	Active Treatment
OTHER	Placebo	Placebo

Timeline

• Start date: 2021-03-22
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2021-03-25
• Last updated: 2022-05-05

Locations

13 sites across 1 country: Australia

Regulatory

• FDA-regulated drug study