A Study to Assess the Efficacy and Safety of Weekly Doses of GLM101 in Participants With PMM2-CDG
Running, not enrolling · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Phosphomannomutase 2 Deficiency, PMM2-CDG
In brief
This study is evaluating the safety, effectiveness, and how the body absorbs, distributes, and eliminates GLM101, for participants with PMM2-CDG, including children, adolescents, and adults. Researchers will compare participants receiving GLM101 to those receiving a placebo to see if GLM101 improves symptoms of PMM2-CDG. The study includes two treatment parts: a 24-week double blind placebo-controlled treatment period (Part A), and a 24-week open-label phase where every participant will receive GLM101(Part B).
Key facts
- Study ID
- NCT06892288
- Run by
- Glycomine, Inc.
- People needed
- 50
- Starts
- 2025-07-09
- Expected to finish
- 2027-04-30
- Last updated by the study team
- 2026-02-27
Who can join
Age: 4 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- University of Minnesota — Minneapolis, Minnesota, United States
- Icahn School of Medicine at Mount Sinai — New York, New York, United States
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Seattle Children's Hospital — Seattle, Washington, United States
- UZ Leuven, Campus Gasthuisberg — Leuven, Belgium
- Vseobecna fakultni nemocnice v Praze — Prague, Czechia
- AP-HP Hopital Necker-Enfants Malades — Paris, France
- Universitaetsklinikum Muenster — Münster, Germany
- Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco — Catania, Italy
- Azienda Ospedaliero Universitaria Pisana — Pisa, Italy
- Instytut Matki i Dziecka — Warsaw, Poland
- Unidade Local de Saúde de Santo António — Porto, Portugal
- Hospital Sant Joan de Déu — Esplugues de Llobregat, Spain
- Hospital Universitario 12 de Octubre — Madrid, Spain
- Birmingham Women's and Children's NHS Foundation Trust — Birmingham, United Kingdom
Full record on ClinicalTrials.gov
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