ADI-PEG20, Obesity and Prediabetes

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05829239
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 22 Years
Healthy Volunteers
Not accepted

Interventions

  • ADI-PEG20 — BIOLOGICAL
    Intramuscular injection weekly for 8 weeks
  • Placebo — OTHER
    Intramuscular injection weekly for 8 weeks

Study Details

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.

Key Dates

Start date
Apr 1, 2024
Status verified
Nov 2024
Primary completion
Apr 1, 2024
Completion
May 1, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: ADI-PEG20
    ADI-PEG20 (ADI-PEG20 is arginine deiminase (ADI) conjugated to polyethylene glycol (PEG) of 20,000 molecular weight) will be weekly intramuscularly at a dose of 18 mg/m2 body surface area/week for 8-week.
  • Placebo Comparator: Placebo
    Will be weekly intramuscularly for 8-week

Primary Outcome Measure

Change in insulin sensitivity [ Time Frame: Baseline and 8 weeks of ADI-PEG20 or placebo ]

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110-

Find similar trials in St Louis, MO

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Washington University School of Medicine· St Louis, MO

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