QX1206 for Type 2 Diabetes and Fatty Liver Disease

Recruiting at 1 trial location

Overseen By 1Globe Health Institute

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: 1Globe Health Institute

Must not be taking: Hepatotoxins, Anti-NAFLD supplements

Disqualifiers: Uncontrolled diabetes, Alcohol use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

52 Participants Needed

Trial Summary

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. ^{1 2 3 4 5}

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.

Research Team

Andrew Keates, PhD

Principal Investigator

1Globe Health Institute

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

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.

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

Treatment Details

Interventions

• QX1206

Trial Overview 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.

Participant Groups

Group I: QX1206 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

1Globe Health Institute

Lead Sponsor

Trials

1

Recruited

50+

Findings from Research

Empagliflozin, when tested in a mouse model of advanced NASH without diabetes, improved glucose homeostasis and reduced inflammation, indicating its potential benefits for liver health even in non-diabetic conditions.

The treatment did not significantly change body weight or insulin sensitivity but positively affected liver pathology by improving the NAFLD activity score, particularly through anti-inflammatory effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Empagliflozin Improves Metabolic and Hepatic Outcomes in a Non-Diabetic Obese Biopsy-Proven Mouse Model of Advanced NASH. Perakakis, N., Chrysafi, P., Feigh, M., et al.[2021]

In a study of 346 patients with type-2 diabetes and biopsy-proven non-alcoholic fatty liver disease (NAFLD), statin use was found to be negatively associated with the presence of non-alcoholic steatohepatitis (NASH) and significant fibrosis (SF), suggesting that statins may help protect against liver damage in these patients.

Conversely, the use of insulin and sulfonylureas was positively associated with NASH and SF, indicating that these medications may contribute to worsening liver conditions in individuals with diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Statins, antidiabetic medications and liver histology in patients with diabetes with non-alcoholic fatty liver disease. Nascimbeni, F., Aron-Wisnewsky, J., Pais, R., et al.[2022]

In a study of 240 NAFLD patients with type 2 diabetes, empagliflozin (EMPA) significantly reduced liver fat content by 8.73%, outperforming both ursodeoxycholic acid (UDCA) and placebo, indicating its efficacy in managing liver steatosis.

While EMPA improved liver fat reduction and beta-cell function, UDCA was more effective in reducing liver fibrosis scores and insulin resistance, suggesting that both treatments have unique benefits in managing NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Impact of an SGLT2 Inhibitor versus Ursodeoxycholic Acid on Liver Steatosis in Diabetic Patients. Elhini, SH., Wahsh, EA., Elberry, AA., et al.[2023]

Tofogliflozin significantly reduced liver enzymes (AST and ALT) and other hepatic markers (GGT, ALP, and MRI-PDFF) in type 2 diabetes patients, indicating potential benefits for liver health.

The review included four randomized clinical trials with 226 subjects, but further studies are needed to confirm tofogliflozin's efficacy on liver outcomes in T2DM patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of tofogliflozin on hepatic outcomes: a systematic review. Pathak, M., Parveen, R., Khan, P., et al.[2023]

In the EFFECT-II study involving 84 participants with type 2 diabetes and non-alcoholic fatty liver disease (NAFLD), the combination of dapagliflozin and omega-3 carboxylic acids significantly reduced liver fat content by 21% compared to placebo, indicating a strong therapeutic effect.

Dapagliflozin alone also demonstrated a disease-modifying effect by reducing biomarkers of hepatocyte injury, suggesting it may help improve liver health in patients with NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Eriksson, JW., Lundkvist, P., Jansson, PA., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Empagliflozin Improves Metabolic and Hepatic Outcomes in a Non-Diabetic Obese Biopsy-Proven Mouse Model of Advanced NASH. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Statins, antidiabetic medications and liver histology in patients with diabetes with non-alcoholic fatty liver disease. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

The Impact of an SGLT2 Inhibitor versus Ursodeoxycholic Acid on Liver Steatosis in Diabetic Patients. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Impact of tofogliflozin on hepatic outcomes: a systematic review. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

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]