Testing QX1206 in patients with Type 2 Diabetes and fatty liver disease
A Phase 1b Study of QX1206 in Type 2 Diabetes Mellitus (T2DM) Patients With Non-Alcoholic Fatty Liver Disease (NAFLD)
This study is testing a new treatment called QX1206 to see if it can help adults with Type 2 diabetes and fatty liver disease manage their blood sugar and improve their health.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | 1Globe Health Institute Industry-sponsored |
| Locations | 1 site (Toronto) |
| Trial ID | NCT06694935 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a diagnosis of T2DM and NAFLD.
Not a fit: Patients with uncontrolled diabetes or significant alcohol consumption may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve metabolic health and manage diabetes in patients with fatty liver disease.
How similar studies have performed: While this approach is novel, similar studies targeting metabolic conditions have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.