BGE-105-003: Study of Azelaprag in COPD Patients
Research type
Research Study
Full title
A Randomised, Double-blind, Placebo-controlled, Parallel-group, Phase 2A, Trial to Assess the Efficacy, Safety, and Tolerability of Azelaprag (BGE-105) to Prevent Acute Skeletal Muscle Atrophy in Participants Hospitalised with an Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)
IRAS ID
1009088
Contact name
Sabine Vukelich
Contact email
Sponsor organisation
BioAge Labs, Inc.
Research summary
Chronic obstructive pulmonary disease (COPD) is a common disease wherein muscle weakness during repeated hospitalisations leads to a range of poor clinical outcomes, including longer hospital stay, higher risk of rehospitalisation, and poor health. This trial will be a randomised, double-blind study of the drug azelaprag compared to a matching placebo during, and immediately following, hospitalisation for an acute exacerbation of COPD (AECOPD) in patients who are at risk of acute muscle wasting. All participants will receive standard of care treatment throughout the study. The proposed trial provides an opportunity to investigate the efficacy and safety of azelaprag on muscle wasting, as well as physical function, quality of life, and future risk of readmission to hospital. Participants must be 60 years of age or older and hospitalised for AECOPD. The study will be conducted at a single site at the University Hospitals of Leicester. The study duration will be up to approximately 18 months from first participant enrolled to last participant visit. The treatment duration will be 10 days for each participant. Participants will have clinic visits daily from Day 1 through Day 10 and return for visits on Days 30, 60, and 90.
REC name
London - Chelsea Research Ethics Committee
REC reference
24/LO/0017
Date of REC Opinion
23 Feb 2024
REC opinion
Further Information Favourable Opinion