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

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

July 9, 2025

Primary Completion Date

January 31, 2026

Study Completion Date

August 31, 2026

Conditions
Phosphomannomutase 2 DeficiencyPMM2-CDG
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

Trial Locations (16)

3000

RECRUITING

UZ Leuven, Campus Gasthuisberg, Leuven

10029

RECRUITING

Icahn School of Medicine at Mount Sinai, New York

19104

RECRUITING

The Children's Hospital of Philadelphia, Philadelphia

28041

NOT_YET_RECRUITING

Hospital Universitario 12 de Octubre, Madrid

48149

NOT_YET_RECRUITING

Universitaetsklinikum Muenster, Münster

55455

NOT_YET_RECRUITING

University of Minnesota, Minneapolis

56126

NOT_YET_RECRUITING

Azienda Ospedaliero Universitaria Pisana, Pisa

75015

RECRUITING

AP-HP Hopital Necker-Enfants Malades, Paris

95124

RECRUITING

Azienda Ospedaliero Universitaria Policlinico G. Rodolico-San Marco, Catania

98105

RECRUITING

Seattle Children's Hospital, Seattle

2, 128 0

RECRUITING

Vseobecna fakultni nemocnice v Praze, Prague

01-211

NOT_YET_RECRUITING

Instytut Matki i Dziecka, Warsaw

4099-001

RECRUITING

Unidade Local de Saúde de Santo António, Porto

08950

RECRUITING

Hospital Sant Joan de Déu, Esplugues de Llobregat

B4 6NH

RECRUITING

Birmingham Women's and Children's NHS Foundation Trust, Birmingham

WC1N 3JH

NOT_YET_RECRUITING

Great Ormond Street Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Glycomine, Inc.

INDUSTRY

NCT06892288 - A Study to Assess the Efficacy and Safety of Weekly Doses of GLM101 in Participants With PMM2-CDG | Biotech Hunter | Biotech Hunter