ADI-PEG20, Obesity and Prediabetes

NCT05829239 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: 202304058
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Obesity; PreDiabetes

Outcome Measures

Primary Outcomes (1)

• Change in insulin sensitivity

  Insulin sensitivity will be assessed by using the hyperinsulinemic-euglycemic clamp procedure

  Baseline and 8 weeks of ADI-PEG20 or placebo

Secondary Outcomes (7)

• Change in oral glucose tolerance

  Baseline and 4 weeks of ADI-PEG20 or placebo

• Change in oral glucose tolerance

  Baseline and 8 weeks of ADI-PEG20 or placebo

• Change in β-cell function

  Baseline and 4 weeks of ADI-PEG20 or placebo

• Change in β-cell function

  Baseline and 8 weeks of ADI-PEG20 or placebo

• Change in resting energy expenditure

  Baseline and 8 weeks of ADI-PEG20 or placebo

Other Outcomes (2)

• Change in the transcriptome in muscle

  Baseline and 8 weeks of ADI-PEG20 or placebo

• Change in the transcriptome in adipose tissue

  Baseline and 8 weeks of ADI-PEG20 or placebo

Study Arms (2)

ADI-PEG20

EXPERIMENTAL

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.

Biological: ADI-PEG20

Placebo

PLACEBO COMPARATOR

Will be weekly intramuscularly for 8-week

Other: Placebo

Interventions

ADI-PEG20 BIOLOGICAL

Intramuscular injection weekly for 8 weeks

ADI-PEG20

Placebo OTHER

Intramuscular injection weekly for 8 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 22 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• HbA1C ≥6.5%;
• Intolerance or allergies to ingredients in ADI-PEG20 or placebo;
• Taking dietary supplements or medications known to affect our study outcomes;
• Evidence of significant organ system dysfunction or diseases,
• Metallic implants, which would preclude MRI

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Children's Discovery Institute: collaborator
• Polaris Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Obesity; Prediabetic State

Interventions

ADI PEG20

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Samuel Klein, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, randomized, double-blind, placebo-controlled study

Study Record Dates

• First Submitted: November 11, 2022
• First Posted: April 25, 2023
• Study Start: April 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)