drugset / Trial / NCT05152641

Study to Evaluate Efficacy and Safety of BGE-117 in Moderately to Severely Anemic Older Individuals After Major Hip Surgery

NCT05152641 ↗

Phase 2 Withdrawn BioAge Labs, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this study is to explore the safety and tolerability of BGE-117 and gain information on the effectiveness of different doses when given to patients 65 years or older with moderate to severe anemia following major hip surgery. BGE-117 is given once daily in a capsule by mouth for up to 12 weeks. Patients are also given oral iron supplements. Anemia following surgery has been associated with decreases in patient functioning. This study will measure improvement of anemia, as well as various patient functioning.

Timeline

Start
2022-04
Primary completion
2023-04
Completion
2024-07

Outcome

Outcome not reported

Stopped (Enrollment): “The program priority for execution of this clinical trial changed prior to enrollment of the first patient. The study was not withdrawn due to any safety concerns.”

Drugs

EvaluationDrugModalityDoseRoute
Subject BGE-117 Unknown 4 mg Oral
Subject BGE-117 Unknown 8 mg Oral
Subject BGE-117 Unknown 16 mg Oral

Indications