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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

Summary

This trial is testing a new drug called ASP0367 to see if it can help people exercise better by improving how their bodies use oxygen. It targets individuals who need better aerobic capacity and aims to make exercising easier for them.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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 study objectives
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
200 Previous Clinical Trials
122,520 Total Patients Enrolled
Senior Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
54 Previous Clinical Trials
12,885 Total Patients Enrolled
~7 spots leftby Nov 2025
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