A Phase 2a Safety, Tolerability, and Pharmacodynamic Study of OMT-28 in PMD patients with myopathy and/or cardiomyopathy and inflammation (PMD-OPTION)

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508541-41-00

Enrollment

Registered

2023-12-12

Start date

2023-05-22

Completion date

2025-05-14

Last updated

2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Mitochondrial Disease

Brief summary

Primary Efficacy Endpoint: Number of patients (responder rate) with a between phase difference in GDF-15 of at least 20% decrease after 12 weeks of treatment., Primary Safety Endpoints: Incidence, severity, seriousness, reported causality, and duration of TEAEs, clinically significant changes in safety laboratory, vital signs, and 12-lead ECG

Interventions

DRUGOMT-28_24mg_cap

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Primary Efficacy Endpoint: Number of patients (responder rate) with a between phase difference in GDF-15 of at least 20% decrease after 12 weeks of treatment., Primary Safety Endpoints: Incidence, severity, seriousness, reported causality, and duration of TEAEs, clinically significant changes in safety laboratory, vital signs, and 12-lead ECG	—

Countries

Germany, Italy, Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026