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New treatment option for Type 2 Diabetes Mellitus (T2DM)
Official title A Phase 1b Study of QX1206 in T2DM Patients With NAFLD
ClinicalTrials.gov ID: NCT06694935
What this study is testing
What is QX1206?
QX1206 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for type 2 diabetes mellitus (t2dm).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.