WithdrawnPhase 2
ADI-PEG20, Obesity and Prediabetes
Key facts
- Who runs it
- Washington University School of Medicine
- Where
- St Louis, United StatesSee the site
- Trial code
- Status
- Withdrawn
- Phase
- Phase 2
- Started
- 1 Apr 2024
- Ended
- 1 May 2024
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- ADI-PEG20
- Placebo
- Record updated
- 7 November 2024
- Why it stopped
- Unable to obtain study drug to be able to perform the study
Who can take part
- Age
- 18 years to 22 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 8 criteriaShow less
Who can take part
- age: ≥18 and ≤22 years
- BMI 25.0 - 44.9 kg/m2
- Prediabetes, defined as fasting plasma glucose of ≥100 mg/dL, or HbA1C ≥5.7%, or HOMA-IR ≥2.5
Who cannot take part
- Taking dietary supplements or medications known to affect our study outcomes
- Metallic implants, which would preclude MRI
- Intolerance or allergies to ingredients in ADI-PEG20 or placebo
- Evidence of significant organ system dysfunction or diseases,
- HbA1C ≥6.5%
Where in United States
- Washington University School of MedicineSt Louis, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- ADI-PEG20Treatment being tested
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.
- PlaceboPlacebo, for comparison
Will be weekly intramuscularly for 8-week
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized Trial Using ADI-PEG20 to Improve Insulin- and Energy Homeostasis in Adolescents With Obesity
- Record updated
- 7 November 2024