QX1206 for Type 2 Diabetes and Fatty Liver Disease
Palo Alto (17 mi)Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: 1Globe Health Institute
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.
What safety data exists for QX1206 in treating Type 2 Diabetes and Fatty Liver Disease?The provided research does not mention QX1206 or any safety data specifically related to it. The articles focus on the safety and efficacy of various treatments for Type 2 Diabetes and Fatty Liver Disease, but none specifically address QX1206.12348
What data supports the idea that QX1206 for Type 2 Diabetes and Fatty Liver Disease is an effective drug?The available research shows that empagliflozin, a drug similar to QX1206, has been effective in improving liver health and managing blood sugar levels in patients with Type 2 Diabetes and Fatty Liver Disease. In one study, empagliflozin significantly reduced liver fat content compared to other treatments like ursodeoxycholic acid and placebo. It also improved glucose control and reduced inflammation in the liver. These results suggest that QX1206 might have similar benefits for these conditions.15679
Is the drug QX1206 a promising treatment for type 2 diabetes and fatty liver disease?The drug QX1206 could be promising for treating type 2 diabetes and fatty liver disease because similar drugs have shown benefits. For example, empagliflozin, a drug for type 2 diabetes, has improved liver health and reduced inflammation in studies. This suggests that QX1206 might also help improve liver conditions and manage diabetes.145610
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you need to stop your current medications. However, you cannot participate if you take drugs associated with NAFLD or known hepatotoxins, or if you use treatments with potential anti-NAFLD effects like high doses of vitamin E.
Eligibility 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
My kidney function, measured by creatinine levels, is within normal limits.
I have been diagnosed with non-alcoholic fatty liver disease.
I am between 18 and 65 years old.
I am a woman who can have children and I have a negative pregnancy test.
Treatment Details
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
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.
Treatment with LY2409021, a glucagon receptor antagonist, increases liver fat in patients with type 2 diabetes. [2022]To evaluate whether treatment with LY2409021, a novel, selective glucagon receptor antagonist, is associated with changes in hepatic fat and other safety variables related to the benefit-risk profile for chronic use in patients with type 2 diabetes (T2D).
Treatment options for nonalcoholic steatohepatitis - a safety evaluation. [2017]There is an urgent as yet unmet need to develop highly effective and safe therapeutics for nonalcoholic fatty liver disease (NAFLD). The remarkable progress in understanding NAFLD pathogenesis allowed the identification of injury pathways which may be recruited as therapy targets. Areas covered: This article reviews the safety and tolerability data of the NAFLD therapies and explains the mechanistic basis for each of the established and investigational drugs. Treatment targets include: weight loss, anti-metabolic agents such as lipid lowering and anti-diabetic drugs, inflammation, fibrosis and others such as targeting gut microbiota, immune modulation and apoptosis. Expert opinion: Current therapies continue to remain suboptimal. Weight loss is effective but hard to achieve. Traditional and endoscopic bariatric procedures are promising although more randomized trials are needed and the long-term safety remains to be established. Clinical trials have demonstrated the efficacy of several drugs for the treatment of NASH. Of these, there remains some uncertainty about the long-term safety of vitamin E. Pioglitazone is associated with osteopenia, fluid retention and weight gain. Obeticholic acid causes pruritus in a substantial proportion of subjects and elafibranor has been associated with transient rises in creatinine. Several exciting therapies are under development and results of clinical and post-marketing trials will help elucidate their safety.
Treating nonalcoholic fatty liver disease in patients with type 2 diabetes mellitus: a review of efficacy and safety. [2022]To review current literature for the efficacy and safety of treatment for nonalcoholic fatty liver disease (NAFLD) in patients with type 2 diabetes mellitus (T2DM).
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).
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.
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
New anti-diabetic agents for the treatment of non-alcoholic fatty liver disease: a systematic review and network meta-analysis of randomized controlled trials. [2023]This network meta-analysis aims to compare the efficacy and safety of new anti-diabetic medications for the treatment of non-alcoholic fatty liver disease (NAFLD).
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.
Effect of dapagliflozin against NAFLD and dyslipidemia in type 2 diabetic albino rats: possible underlying mechanisms. [2023]The aim was to investigate the effect of dapagliflozin on non-alcoholic fatty liver disease and dyslipidemia in type 2 diabetic rats by studying the histopathological structure of the liver and detecting possible underlying mechanisms for this impact by evaluating the potential anti-inflammatory action of dapagliflozin.