Type 2 Diabetes Mellitus study: QX1206
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 oral medicine being studied for type 2 diabetes and fatty liver disease.
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 study aims to find the best dose of the drug for future testing and to see how it affects blood sugar and other health markers.
- Who it's for
- The study is looking for adults who have both type 2 diabetes and non-alcoholic fatty liver disease.
- What's involved
- Participants will take the study drug and undergo regular blood tests and other health checks to monitor safety and effects.
- Time commitment
- The study involves ongoing visits and tests to track the drug's effects, but the total duration is not specified.
- 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
- Fasting triglycerides \> 500 mg/dL
- Fasting direct LDL-C \> 190 mg/dL
- AST \> 5.0 × upper limit of normal (ULN)
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
- 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 is enrolling
- 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, but 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?
This study is enrolling now at Toronto, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.