Recruiting
Phase 1

QX1206

Sponsor:

1Globe Health Institute

Code:

NCT06694935

Conditions

Type 2 Diabetes Mellitus (T2DM)

Non-Alcoholic Fatty Liver Disease (NAFLD)

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

QX1206

Study Details

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 the study to determine the recommended phase 2 dose. In addition, the preliminary effects of QX1206 on antidiabetic activity and other metabolic parameters will also be evaluated.

Conditions

Type 2 Diabetes Mellitus (T2DM)

Non-Alcoholic Fatty Liver Disease (NAFLD)

Study ID

NCT06694935

Start date

Jan 6, 2025

Status verified date

Jan, 2025

Completion date

Dec, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 64

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

52 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: QX1206

Interventions

QX1206

QX1206 will be administered orally before bedtime

Primary outcome measure

  • Recommended Phase 2 Dose (RP2D) [ Time Frame: Baseline Day 1 up to Week 12 ]

Central Contacts and Locations

Central contacts

1Globe Health Institute

617-649-1157T2DM-QX1206-1_Study@1globe-usa.com

Locations

Centricity Research Toronto LMC.

Recruiting

Toronto, Canada

Contacts

Clinical Research Coordinator

416-645-2929, Ext 9232arlene.vinas@centricityresearch.com

More Information

Sponsor

1Globe Health Institute

Last update posted

Jan 13, 2025

Last verified

Jan, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by 1Globe Health Institute on 2025-01-13.