Testing QX1206 in patients with Type 2 Diabetes and fatty liver disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label phase 1b trial evaluates the safety and efficacy of QX1206 in patients diagnosed with Type 2 Diabetes Mellitus (T2DM) and Non-Alcoholic Fatty Liver Disease (NAFLD). Participants will undergo laboratory tests and assessments before and during the treatment to determine the recommended dose for future studies. The trial aims to observe the preliminary effects of QX1206 on blood sugar control and other metabolic parameters. The study will include adults aged 18 to 65 with specific health criteria.

Why it matters

Who can join: the full rules

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

Where it's running

• Centricity Research Toronto LMC.
  Toronto, Canada Recruiting

Study contacts

• Study coordinator: 1Globe Health Institute
• Email: T2DM-QX1206-1_Study@1globe-usa.com
• Phone: 617-649-1157

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.