Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
52 participants
INTERVENTIONAL
2025-01-06
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Semaglutide Treatment in the Real-world for Fibrosis Due to NAFLD in Obesity and T2DM
NCT06005012
A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease
NCT05970640
Study of Liraglutide Versus Insulin on Liver Fat Fraction in Patients With Type 2 Diabetes
NCT01399645
A Phase 1 Study of DD01 in Overweight/Obese Subjects With T2DM and NAFLD
NCT04812262
A Study of Efinopegdutide (MK-6024) in Participants With Nonalcoholic Fatty Liver Disease (NAFLD) (MK-6024-001)
NCT04944992
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
QX1206
QX1206
QX1206 will be administered orally before bedtime
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
QX1206
QX1206 will be administered orally before bedtime
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
64 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
1Globe Health Institute
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrew Keates, PhD
Role: STUDY_DIRECTOR
1Globe Health Institute
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centricity Research Toronto LMC.
Toronto, , Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
T2DM-QX1206-1
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.