Status:

RECRUITING

A Phase 1b Study of QX1206 in T2DM Patients With NAFLD

Lead Sponsor:

1Globe Health Institute

Conditions:

Type 2 Diabetes Mellitus (T2DM)

Non-Alcoholic Fatty Liver Disease (NAFLD)

Eligibility:

All Genders

18-64 years

Phase:

PHASE1

Brief Summary

This is an open label phase 1b trial of QX1206 in patients with T2DM and with NAFLD. Laboratory tests and other measurements will be assessed prior to the first dose of study treatment and throughout ...

Eligibility Criteria

Inclusion Criteria:

  • Signed written informed consent must be obtained and documented
  • 18 years of age and < 65 years old
  • BMI ≥ 18 kg/m^2 and < 45 kg/m^2
  • T2DM diagnosed per 2021 American Diabetes Association criteria
  • Diagnosis of NAFLD
  • For male or female patients of child producing potential: must agree to use contraception or take measures to avoid pregnancy during the study
  • Women of child-bearing potential (WOCBP) must have a negative pregnancy test
  • Serum creatinine < 1.5×ULN or creatinine clearance ≥ 60 ml/min
  • Participating patients must be able to comply with all study requirements and the study center must have appropriate means of ensuring protocol compliance for each participating patient

Exclusion Criteria:

  • Uncontrolled diabetes
  • Patients with an active, serious medical disease that limit activities of daily living
  • Patients with current, significant alcohol consumption or a history of significant alcohol consumption
  • Patients with any of the following clinical laboratory abnormalities at screen and confirmed by a single repeat if deemed necessary:
  • Fasting triglycerides > 500 mg/dL
  • Fasting direct LDL-C > 190 mg/dL
  • AST > 5.0 × upper limit of normal (ULN)
  • ALT > 5.0 × ULN
  • Alkaline phosphatase (ALP) ≥ 2 × ULN
  • HbA1c > 10.5%
  • Fasting plasma glucose (FPG) > 240 mg/dL (13.3 mmol/L)
  • Platelets count < 140,000/mm^3
  • Patient takes drugs historically associated with NAFLD and other known hepatotoxins
  • Treatment with drugs (e.g., vitamin E > 400 IU/day) or herbal supplements with potential anti-NAFLD effect

Key Trial Info

Start Date :

January 6 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 1 2025

Estimated Enrollment :

52 Patients enrolled

Trial Details

Trial ID

NCT06694935

Start Date

January 6 2025

End Date

December 1 2025

Last Update

January 13 2025

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Centricity Research Toronto LMC.

Toronto, Canada