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ACTIVE NOT RECRUITING
NCT06892288
PHASE2/PHASE3

A Study to Assess the Efficacy and Safety of Weekly Doses of GLM101 in Participants With PMM2-CDG

Sponsor: Glycomine, Inc.

View on ClinicalTrials.gov

Summary

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).

Official title: A Phase 2b, Multicenter, Double-blind, Randomized, Placebo Controlled Study to Assess the Efficacy and Safety of Weekly Doses of GLM101 Administered Intravenously to Participants With PMM2-CDG (POLAR Trial)

Key Details

Gender

All

Age Range

4 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2025-07-09

Completion Date

2027-04-30

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

DRUG

GLM101 (Part A, Double-blind)

IV infusions, 30 mg/kg once weekly for 24 weeks, for participants randomized to GLM101 in Part A

DRUG

Placebo (Part A, Double-blind)

IV infusions, 30 mg/kg once weekly for 24 weeks, for participants randomized to Placebo in Part A

DRUG

GLM101 (Part B, Open-label)

IV infusions, 30 mg/kg once weekly from week 25 to 48, to all participants

Locations (15)

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