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Fatty Acid Oxidation Inhibitor

Mavodelpar for Mitochondrial Myopathy (STRIDE Trial)

Phase 2
Waitlist Available
Led By Amel Karaa, MD
Research Sponsored by Reneo Pharma Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to week 24

Summary

This trial will test if a new drug, REN001, is effective and safe for treating PMM (a 24-week study).

Eligible Conditions
  • Mitochondrial Myopathy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Distance Walked During a 12 Minute Walk Test
Secondary study objectives
Change in PROMIS Short Form - Fatigue 13a (FACIT-fatigue) Scores
Other study objectives
Change Work Productivity and Activity Impairment Questionnaire: Specific Health Problem (WPAI:SHP) score
Change in 36-Item Short Form Health Survey (SF-36) score
Change in Brief Pain Inventory (BPI) score
+6 more

Side effects data

From 2023 Phase 2 trial • 213 Patients • NCT04535609
19%
Refraction Disorder
19%
COVID-19
10%
Blood Creatine Phosphokinase Increased
9%
Headache
9%
Nausea
9%
Diarrhea
8%
Back Pain
8%
Myalgia
8%
Vomiting
7%
Rash
6%
Fatigue
6%
Vitamin D Deficiency
6%
Dizziness
6%
Fall
2%
Cerebrovascular Accident
1%
Pancreatitis
1%
Pyelonephritis Acute
1%
Humerus Fracture
1%
Angina Pectoris
1%
Pneumonia
1%
Hospitalization
1%
Death
1%
Epilepsy
1%
Diabetic Ketoacidosis
1%
Seizure
1%
Concussion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Matched Placebo
Mavodelpar

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: MavodelparExperimental Treatment1 Intervention
Once daily
Group II: Matched placeboPlacebo Group1 Intervention
Once daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mavodelpar
2021
Completed Phase 2
~220

Find a Location

Who is running the clinical trial?

Reneo Pharma LtdLead Sponsor
5 Previous Clinical Trials
282 Total Patients Enrolled
Amel Karaa, MDPrincipal InvestigatorMassachusetts General Hospital (MGH)
4 Previous Clinical Trials
550 Total Patients Enrolled

Media Library

REN001 (Fatty Acid Oxidation Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04535609 — Phase 2
Mitochondrial Myopathy Research Study Groups: Mavodelpar, Matched placebo
Mitochondrial Myopathy Clinical Trial 2023: REN001 Highlights & Side Effects. Trial Name: NCT04535609 — Phase 2
REN001 (Fatty Acid Oxidation Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04535609 — Phase 2
~48 spots leftby Nov 2025
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