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Follistatin 344

FS-344, Activin-Binding Protein, FST344

Quick Stats
Studies 2
Trials 73
Completed PHASE1 INTERVENTIONAL NCT04386304

Safety and Biomarker Response to (+)-Epicatechin in Becker Muscular Dystrophy

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

This is a Phase 1, open-label, dose escalation study aimed at evaluating the safety, early efficacy and potential biomarkers of (+)-epicatechin in patients with Becker or Becker-like Muscular Dystrophy (BMD).

Detailed Description

The safety and tolerability of three escalating doses of (+)-epicatechin will be assessed and early effectiveness measured by changes in plasma biomarkers, tissue biomarkers from muscle biopsies, cardiac imaging, and on clinical function assessments of participants' muscle strength. All patients will receive oral (+)-epicatechin for a total duration of approximately 52 weeks. Three doses of (+)-epicatechin will be tested in sequential 2 month periods with total daily doses of 75, 150, and 225 mg/day (+)-epicatechin. Doses will be escalated every 2 months, if tolerated, for the first 6 months of the study. Participants will then continue to receive the highest does they tolerated for an additional 6 months.

Interventions

Name: (+)-Epicatechin
Type: DRUG
Description: (+)-Epicatechin is a synthetic flavanol

Primary Outcomes

Measure: Number of participants with treatment-emergent adverse events (TEAEs)
TimeFrame: Through study completion, up to 1 year
Description: The TEAEs will be graded using the adult National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

Trial Information

NCT ID

NCT04386304

Status

Completed

Study Type

INTERVENTIONAL

Phases

PHASE1

Sponsor

Epirium Bio Inc.

Last Updated

December 15, 2025

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