NCT05095727 is a Phase 1, PHASE2 clinical trial of mRNA-3745 in Glycogen Storage Disease, sponsored by ModernaTX, Inc..

Who is sponsoring NCT05095727?

NCT05095727 is sponsored by ModernaTX, Inc..

What drugs are being tested in NCT05095727?

Interventions in NCT05095727: mRNA-3745.

What condition does NCT05095727 study?

NCT05095727 studies Glycogen Storage Disease.

Is NCT05095727 still recruiting?

NCT05095727 is currently active, enrolled. Last updated 15 December 2025.

Last reviewed 2025-12-15 · How we verify

NCT05095727

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of mRNA-3745 in Adult and Pediatric Participants With Glycogen Storage Disease Type 1a (GSD1a)

Active, enrolled Phase 1, PHASE2 Last updated 15 December 2025

What this trial tests

Phase 1, PHASE2 trial testing mRNA-3745 in Glycogen Storage Disease in 15 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 June 2022

Primary endpoint
30 November 2026

30 November 2026

Quick facts

Lead sponsor	ModernaTX, Inc.
Phase	Phase 1, PHASE2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	15
Start date	1 June 2022
Primary completion	30 November 2026
Estimated completion	30 November 2026
Sites	16 locations across France, Netherlands, Poland, Canada, United States, Spain

Drugs / interventions tested

mRNA-3745 — full drug profile →

Conditions studied

Glycogen Storage Disease — all drugs for Glycogen Storage Disease →

Sponsor

ModernaTX, Inc. — full company profile →

Who can join

6 and older, any sex, with Glycogen Storage Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The main goal of this trial is to evaluate the safety and tolerability of mRNA-3745 via intravenous (IV) administration in adult and pediatric participants with GSD1a.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

mRNA vaccines in disease prevention and treatment.
Zhang G, Tang T, Chen Y, Huang X, et al · · 2023 · cited 148× · PMID 37726283 · DOI 10.1038/s41392-023-01579-1
mRNA nanomedicine: Design and recent applications.
Kubiatowicz LJ, Mohapatra A, Krishnan N, Fang RH, et al · · 2022 · cited 88× · PMID 36249890 · DOI 10.1002/exp.20210217
Amplifying gene expression with RNA-targeted therapeutics.
Khorkova O, Stahl J, Joji A, Volmar CH, et al · · 2023 · cited 78× · PMID 37253858 · DOI 10.1038/s41573-023-00704-7
Progress and prospects of mRNA-based drugs in pre-clinical and clinical applications.
Shi Y, Shi M, Wang Y, You J. · · 2024 · cited 67× · PMID 39543114 · DOI 10.1038/s41392-024-02002-z
Targeting materials and strategies for RNA delivery.
Lin L, Su K, Cheng Q, Liu S. · · 2023 · cited 36× · PMID 37649616 · DOI 10.7150/thno.87316
mRNA and gene editing: Late breaking therapies in liver diseases.
Zabaleta N, Torella L, Weber ND, Gonzalez-Aseguinolaza G. · · 2022 · cited 32× · PMID 35243655 · DOI 10.1002/hep.32441
Composition of lipid nanoparticles for targeted delivery: application to mRNA therapeutics.
Vasileva O, Zaborova O, Shmykov B, Ivanov R, et al · · 2024 · cited 29× · PMID 39508050 · DOI 10.3389/fphar.2024.1466337
Clinical development of therapeutic mRNA applications.
Żak MM, Zangi L. · · 2025 · cited 28× · PMID 40143545 · DOI 10.1016/j.ymthe.2025.03.034

Verify or expand the search:

Other recruiting trials for Glycogen Storage Disease

Currently open trials in the same condition.

NCT06813443 — Characterization of Patients With Cardiomyopathy to Identify Critical Patients Candidates for Cardiac Transplantation · recruiting
NCT07336394 — Precision Diagnosis and Risk Stratification of Rare Cardiomyopathies Based on Novel Cardiac Magnetic Resonance Technique · recruiting

Other ModernaTX, Inc. trials

Trials by the same sponsor.

NCT07496450 — A Study of mRNA-1018-H5 Pandemic Influenza Vaccine in Healthy Adults · Phase 3 · recruiting
NCT07478952 — A Study of an Epstein-Barr Virus (EBV) Candidate Vaccine, mRNA-1189 in Healthy Adults 18 to 30 Years of Age · Phase 1 · recruiting
NCT07266558 — A Study to Evaluate the Efficacy and Safety of mRNA-1283 and mRNA-1273 in Participants 50 to 64 Years of Age Without Hig · Phase 4 · recruiting
NCT07116616 — A Study of mRNA-2808 in Participants With Relapsed or Refractory Multiple Myeloma · Phase 1, PHASE2 · recruiting
NCT07117487 — A Study of mRNA-1345 Following a Primary Dose of a Licensed Protein Subunit Respiratory Syncytial Virus (RSV) Vaccine in · Phase 3 · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05095727 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ModernaTX, Inc.
Last refreshed: 15 December 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05095727.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing