QX1206 for Type 2 Diabetes and Fatty Liver Disease
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: 1Globe Health Institute
Must not be taking: Hepatotoxins, Anti-NAFLD supplements
Disqualifiers: Uncontrolled diabetes, Alcohol use, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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. In addition, the preliminary effects of QX1206 on antidiabetic activity and other metabolic parameters will also be evaluated.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you take drugs associated with fatty liver disease or certain supplements with potential anti-fatty liver effects.
What data supports the effectiveness of the drug QX1206 for Type 2 Diabetes and Fatty Liver Disease?
Research on similar drugs like empagliflozin, which is used for type 2 diabetes, shows it can improve liver health by reducing inflammation and liver fat in patients with non-alcoholic fatty liver disease. This suggests that QX1206 might have similar benefits for these conditions.
12345Eligibility Criteria
This trial is for adults aged 18-65 with Type 2 Diabetes Mellitus (T2DM) and Non-alcoholic Fatty Liver Disease (NAFLD). Participants must meet specific diabetes criteria, have a Body Mass Index (BMI) between 18 and 45, and functionally healthy kidneys. Women who can bear children need a negative pregnancy test and agree to use contraception.Inclusion Criteria
I have signed the consent form for this trial.
My BMI is between 18 and 45.
I agree to use birth control or avoid pregnancy during the study.
+6 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive QX1206 to evaluate its effects on antidiabetic activity and metabolic parameters
12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests QX1206's safety, proper dosage for Phase 2 trials, its effects on blood sugar control, and other metabolic outcomes in T2DM patients with NAFLD. It's an early-stage trial where everyone gets the drug; their health is closely monitored throughout.
1Treatment groups
Experimental Treatment
Group I: QX1206Experimental Treatment1 Intervention
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Centricity Research Toronto LMC.Toronto, Canada
Centricitv Research Toronto LMC.Toronto, Canada
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Who Is Running the Clinical Trial?
1Globe Health InstituteLead Sponsor
References
Empagliflozin Improves Metabolic and Hepatic Outcomes in a Non-Diabetic Obese Biopsy-Proven Mouse Model of Advanced NASH. [2021]Empagliflozin, an established treatment for type 2 diabetes (T2DM), has shown beneficial effects on liver steatosis and fibrosis in animals and in humans with T2DM, non-alcoholic fatty liver disease (NAFLD) and steatohepatitis (NASH). However, little is known about the effects of empagliflozin on liver function in advanced NASH with liver fibrosis and without diabetes. This study aimed to assess the effects of empagliflozin on hepatic and metabolic outcomes in a diet-induced obese (DIO) and insulin-resistant but non-diabetic biopsy-confirmed mouse model of advanced NASH. Male C57BL/6JRj mice with a biopsy-confirmed steatosis and fibrosis on AMLN diet (high fat, fructose and cholesterol) for 36-weeks were randomized to receive for 12 weeks: (a) Empagliflozin (10 mg/kg/d p.o.), or (b) vehicle. Metabolic outcomes, liver pathology, markers of Kupffer and stellate cell activation and lipidomics were assessed at the treatment completion. Empagliflozin did not affect the body weight, body composition or insulin sensitivity (assessed by intraperitoneal insulin tolerance test), but significantly improved glucose homeostasis as assessed by oral glucose tolerance test in DIO-NASH mice. Empagliflozin improved modestly the NAFLD activity score compared with the vehicle, mainly by improving inflammation and without affecting steatosis, the fibrosis stage and markers of Kupffer and stellate cell activation. Empagliflozin reduced the hepatic concentrations of pro-inflammatory lactosylceramides and increased the concentrations of anti-inflammatory polyunsaturated triglycerides. Empagliflozin exerts beneficial metabolic and hepatic (mainly anti-inflammatory) effects in non-diabetic DIO-NASH mice and thus may be effective against NASH even in non-diabetic conditions.
Statins, antidiabetic medications and liver histology in patients with diabetes with non-alcoholic fatty liver disease. [2022]Type-2 diabetes mellitus (T2DM) is a risk factor for progressive non-alcoholic fatty liver disease (NAFLD). Drugs commonly prescribed in patients with T2DM may affect liver histology by interfering with lipid metabolism and insulin resistance/secretion.
The Impact of an SGLT2 Inhibitor versus Ursodeoxycholic Acid on Liver Steatosis in Diabetic Patients. [2023]Non-alcoholic fatty liver disease (NAFLD) is related to metabolic syndrome via insulin resistance, where preventing disease progression is crucial in the management process. The study included 240 NAFLD patients with type 2 diabetes who were randomly allocated into empagliflozin 25 mg (EMPA group), ursodeoxycholic acid 250 mg (UDCA group), or the control group (placebo). The study outcomes included: changes in liver fat content (LFC; %) (utilizing the Dixon-based MRI-PDFF approach), liver enzymes, lipid and glycemic profiles, FIB-4 index, and non-alcoholic fatty liver score (NFS). All endpoints were assessed at baseline and after 6 months. EMPA outperformed UDCA and placebo in decreasing LFC (−8.73% vs. −5.71% vs. −1.99%; p
Impact of tofogliflozin on hepatic outcomes: a systematic review. [2023]Studies have demonstrated a high prevalence of non-alcoholic fatty liver disease (NAFLD) in type 2 diabetes mellitus (T2DM) patients. The aim was to review the effect of tofogliflozin on hepatic outcomes in T2DM patients.
Effects of dapagliflozin and n-3 carboxylic acids on non-alcoholic fatty liver disease in people with type 2 diabetes: a double-blind randomised placebo-controlled study. [2021]The EFFECT-II study aimed to investigate the effects of dapagliflozin and omega-3 (n-3) carboxylic acids (OM-3CA), individually or combined, on liver fat content in individuals with type 2 diabetes and non-alcoholic fatty liver disease (NAFLD).