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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called QX1206 for individuals with Type 2 Diabetes and fatty liver disease. The main goal is to determine the optimal dose of QX1206 and assess its effects on blood sugar and other health markers. Individuals with Type 2 Diabetes and a diagnosis of fatty liver disease may be suitable candidates for this trial. Participants must follow all study procedures and commit to using effective birth control if pregnancy is possible. As a Phase 1 trial, this research aims to understand how QX1206 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that QX1206 is likely to be safe for humans?

Research shows that QX1206 remains in the early stages of testing to determine its safety for people. As a result, there is limited information about its tolerability and potential side effects. In these early trials, researchers primarily focus on assessing the treatment's safety and identifying the appropriate dose for future studies.

Since QX1206 has not been approved for any conditions, safety data from other uses is unavailable. However, reaching this stage of testing suggests that initial lab and animal studies did not reveal major safety issues. Researchers will closely monitor participants for any side effects during the trial to ensure it is safe to proceed with further testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

QX1206 is unique because it targets both type 2 diabetes and fatty liver disease, two conditions that often occur together. Most treatments for type 2 diabetes focus on controlling blood sugar levels, like metformin or insulin therapy, and typically don't address liver health. QX1206, however, is thought to work by influencing pathways that affect both glucose metabolism and liver fat accumulation. This dual action could potentially offer a more comprehensive approach to managing these interconnected conditions, which is why researchers are excited about its possibilities.

What evidence suggests that QX1206 might be an effective treatment for Type 2 Diabetes and Fatty Liver Disease?

Research shows that QX1206, the investigational treatment studied in this trial, might benefit people with Type 2 Diabetes (T2DM) and Non-Alcoholic Fatty Liver Disease (NAFLD). Early results suggest it targets the body's systems often imbalanced in these conditions. Both T2DM and NAFLD involve issues with sugar and fat management, and QX1206 is designed to address these problems. Although human studies provide limited data, the treatment aims to improve sugar and fat handling, potentially reducing symptoms and complications. Initial research indicates potential benefits in managing these issues. ^{2 6 7 8 9}

Who Is on the Research Team?

Andrew Keates, PhD

Principal Investigator

1Globe Health Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: QX1206 Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

1Globe Health Institute

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

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 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]

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]

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]

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]

Citations

1. adisinsight.springer.com adisinsight.springer.com/trials/700378512

A Phase 1b Study of QX1206 in Type 2 Diabetes Mellitus ... A Phase 1b Study of QX1206 in Type 2 Diabetes Mellitus (T2DM) Patients With Non-Alcoholic Fatty Liver Disease (NAFLD). Status: Recruiting.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6063173/

Nonalcoholic Fatty Liver Disease and Type 2 Diabetes ... Type 2 diabetes mellitus (T2DM) and nonalcoholic fatty liver disease (NAFLD) commonly exist together. It has been regarded as a manifestation of the metabolic ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT01002547?cond=%22Diabetes%20Mellitus,%20Noninsulin-Dependent%22&intr=%22Tocopherol%22&viewType=Table&rank=8&tab=results

Study Results | Prevalence of Non-alcoholic Fatty Liver ... A general description of the clinical trial arm. It identifies the role of the intervention that participants receive. Types of arms include experimental arm, ...

4. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-023-03129-6

a systematic review and Bayesian network meta-analysis of ... ... fat content in type 2 diabetes patients with non-alcoholic fatty liver disease. J Diabetes Investig. 2019;10(4):1004–11. Article CAS PubMed ...

5. frontiersin.org frontiersin.org/journals/endocrinology/articles/10.3389/fendo.2023.1156381/full

Nonalcoholic fatty liver disease and type 2 diabetes ... NAFLD and incident diabetes, and the results remained unchanged. ... hepatic steatosis led to a 30% increased risk of T2D (26). Since ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06694935

A Phase 1b Study of QX1206 in T2DM Patients With NAFLD A Phase 1b Study of QX1206 in Type 2 Diabetes Mellitus (T2DM) Patients With Non-Alcoholic Fatty Liver Disease (NAFLD). Conditions. Type 2 Diabetes Mellitus ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37491159/

Global prevalence of non-alcoholic fatty liver disease in ... This meta-analysis aims to quantify the prevalence of NAFLD and the prevalence of clinically significant and advanced fibrosis in people with T2DM.

8. bmcmedicine.biomedcentral.com bmcmedicine.biomedcentral.com/articles/10.1186/s12916-024-03315-0

Global epidemiology of type 2 diabetes in patients with ... Across diagnosis of NAFLD, the pooled prevalence of type 2 diabetes among patients with NAFLD was the lowest in index (n = 20; 17.4%; 95% CI ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34956080/

Efficacy and Safety of GLP-1 Receptor Agonists in Patients ... GLP-1RAs were an effective treatment that improved intrahepatic visceral and subcutaneous adipose tissue, inflammatory markers, the anthropometric profiles and ...