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

NCT06892288 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-02-27

No results posted yet for this study

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).

Conditions

  • Phosphomannomutase 2 Deficiency
  • PMM2-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

Sponsors & Collaborators

  • Glycomine, Inc.

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Glycomine, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-09
Primary Completion
2026-09-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • Portugal
  • Spain
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06892288 on ClinicalTrials.gov