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ADI-PEG20, Obesity and Prediabetes

NCT05829239 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-11-07

No results posted yet for this study

Summary

Th purpose of this study is to determine whether ADI-PEG20 (PEGylated arginine deiminase), an arginine catabolizing enzyme preparation, improves insulin sensitivity, mitochondrial respiration, and energy utilization in adolescents with prediabetes.

Conditions

Interventions

BIOLOGICAL

ADI-PEG20

Intramuscular injection weekly for 8 weeks

OTHER

Placebo

Intramuscular injection weekly for 8 weeks

Sponsors & Collaborators

  • Children's Discovery Institute

    collaborator OTHER

  • Polaris Pharmaceuticals, Inc.

    collaborator UNKNOWN

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Samuel Klein, MD · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-01
Primary Completion
2024-04-01
Completion
2024-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT05829239 on ClinicalTrials.gov