HU6 for Type 2 Diabetes with Risk of Fatty Liver Disease

Not currently recruiting at 23 trial locations

Overseen By Pavla Bednarek, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rivus Pharmaceuticals, Inc.

Must not be taking: Insulin, Antidiabetics, Stimulants, Anticoagulants

Disqualifiers: Cirrhosis, Pancreatitis, Bariatric surgery, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 26 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HU6 to determine its effectiveness for people with type 2 diabetes who are at risk of developing fatty liver disease. The study will compare different doses of HU6 to a placebo (a non-active treatment) to assess its safety in reducing liver fat. Participants must have type 2 diabetes and show signs of fatty liver disease, such as increased liver fat on scans. The trial seeks individuals who have been managing these conditions and are willing to participate in a 6-month study. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

Yes, you may need to stop certain medications to join the trial. Specifically, some oral antidiabetic drugs, weight loss medications, certain stimulants, and other specified drugs are prohibited within 3 months prior to screening and during the study.

Is there any evidence suggesting that HU6 is likely to be safe for humans?

Research has shown that HU6 has been tested in people with non-alcoholic fatty liver disease (NAFLD) and high body weight, conditions similar to those in this trial. In these studies, participants generally tolerated HU6 well. Most side effects were mild and temporary, such as headaches or mild stomach issues, while serious side effects were rare. This suggests that HU6 is reasonably safe for humans. However, individual experiences can vary with any treatment. Participants should maintain close contact with the trial team if they choose to participate. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Type 2 Diabetes?

Most treatments for type 2 diabetes focus on managing blood sugar levels, often using drugs like metformin or insulin. But HU6 is different because it not only targets diabetes but also addresses the risk of fatty liver disease, which is a common concern for people with diabetes. HU6 works by potentially enhancing the body's energy metabolism, helping to reduce fat buildup in the liver. Researchers are excited about HU6 because it offers a dual approach, tackling both blood sugar management and liver health, which could lead to better overall outcomes for patients.

What evidence suggests that HU6 might be an effective treatment for Type 2 Diabetes with risk of fatty liver disease?

Research has shown that HU6, which participants in this trial may receive, yields promising results in reducing liver fat in people with nonalcoholic fatty liver disease (NAFLD). In earlier studies, participants taking HU6 experienced a significant drop in liver fat compared to those on a placebo. HU6 accelerates fat breakdown, potentially leading to weight loss and improved liver health. This is particularly important because NAFLD often coexists with type 2 diabetes, making HU6 potentially beneficial for individuals with both conditions. These findings suggest that HU6 could be a viable treatment option for reducing liver fat and enhancing overall health. ^{2 3 5 6 7}

Who Is on the Research Team?

Rob Schott, MD

Principal Investigator

Rivus Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

This trial is for obese adults with type 2 diabetes who may be at risk of developing a liver condition called nonalcoholic steatohepatitis (NASH). Participants must have tried and failed to lose weight through diet, use effective contraception, and not have had significant weight changes or cancer treatment within the last five years.

Inclusion Criteria

I agree to use contraception during and 90 days after the study if I haven't had a confirmed vasectomy.

I have type 2 diabetes.

I am not pregnant or breastfeeding and will use effective birth control during the study.

Exclusion Criteria

I have gained or lost more than 5% of my weight in the last 3 months.

I have not been treated for any type of cancer in the last 5 years.

I have lost more than 10 pounds between my screening and first visit.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

7 weeks

Multiple visits (in-person)

Treatment

Participants receive one of three dose levels of HU6 or placebo for 26 weeks

26 weeks

Regular visits for safety, efficacy, PD, and PK monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

End-of-study visit approximately 4 weeks after last dose

What Are the Treatments Tested in This Trial?

Interventions

• HU6
• Placebo

Trial Overview The study tests three different doses of a drug named HU6 against a placebo in managing NASH risk in obese patients with type 2 diabetes. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real drug or placebo during the six-month trial period.

How Is the Trial Designed?

Group I: Active Treatment: HU6 Planned doses of HU6 Experimental Treatment 1 Intervention

Group II: Placebo Comparator Non-active study drug Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Rivus Pharmaceuticals, Inc.

Lead Sponsor

Trials

9

Recruited

540+

Citations

1. thelancet.com thelancet.com/journals/langas/article/PIIS2468-1253(23)00198-X/abstract

Safety and efficacy of once-daily HU6 versus placebo in ... Loomba, R ∙ Kayali, Z ∙ Noureddin, M ∙ et al. GS-0976 reduces hepatic steatosis and fibrosis markers in patients with nonalcoholic fatty liver ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04874233

Phase 2a Study of HU6 in Subjects With Elevated Liver Fat ... Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and ... Fatty Liver. Liver Diseases. Digestive System Diseases. Non-alcoholic Fatty Liver Disease ...

3. prnewswire.com prnewswire.com/news-releases/phase-2a-study-of-hu6-rivus-pharmaceuticals-investigational-controlled-metabolic-accelerator-demonstrates-clinical-benefit-in-patients-with-high-body-mass-index-and-nonalcoholic-fatty-liver-disease-301949019.html

Phase 2a Study of HU6, Rivus Pharmaceuticals ... ... Nonalcoholic Fatty Liver Disease. Rivus Pharmaceuticals Logo. News ... Results showed that HU6 significantly reduced liver fat compared ...

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

Nonalcoholic Fatty Liver Disease and Type 2 Diabetes ... Nonalcoholic fatty liver disease (NAFLD) and type 2 diabetes (T2DM) often coexist.[1] The prevalence of NAFLD is 59.67% in T2DM patients.[1] This results in ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S246812532300198X

Safety and efficacy of once-daily HU6 versus placebo in ... ... fatty liver disease (NAFLD), NASH, diabetes, and obesity. Added value of ... HU6 results in fat-specific weight loss due to preferential oxidation of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37806314/

Safety and efficacy of once-daily HU6 versus placebo in ... We aimed to assess the safety and efficacy of HU6 compared with placebo in people with non-alcoholic fatty liver disease (NAFLD) and high BMI.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05979779

Ph 2 Study of the Safety and Efficacy of Three HU6 Dose ... This is a phase 2 randomized, double-blind, placebo-controlled parallel group study of 3 dose levels of HU6 in subjects with nonalcoholic steatohepatitis ...