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Bocidelpar for Reduced Maximum Oxygen Uptake Syndrome

Phase 1
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to week 7
Awards & highlights

Study Summary

This trial will study ASP0367, a potential new drug, to see if it is better than placebo at improving aerobic capacity, as well as safety and tolerability. It will also compare the drug to placebo in terms of other measures of aerobic capacity and functional capacity.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline up to week 7
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to week 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cardiopulmonary Exercise Test
Number of Participants With 12-lead Electrocardiogram (ECG) Abnormalities and/or Adverse Events (AEs)
Number of Participants With Laboratory Value Abnormalities and/or Adverse Events (AEs)
+3 more
Secondary outcome measures
Change from baseline in multivariable gas exchange index (MGI) during SHAPE Test.
Change from baseline in percent predicted VO2max during aCPET
Change from baseline in systemic oxygen extraction (SOE)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Bocidelpar (ASP0367)Experimental Treatment1 Intervention
Participants will receive Bocidelpar (ASP0367) once daily in the morning for 6 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo once daily in the morning for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bocidelpar
2021
Completed Phase 1
~40

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
195 Previous Clinical Trials
121,466 Total Patients Enrolled
Senior Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
54 Previous Clinical Trials
13,046 Total Patients Enrolled
~8 spots leftby Jun 2025
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