180 Participants NeededMy employer runs this trial

HU6 for Fatty Liver Disease

(AMPLIFY Trial)

Recruiting at 32 trial locations
CO
VC
Overseen ByVP, Clinical Operations
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a potential new treatment called HU6 for individuals with metabolic dysfunction-associated steatohepatitis (MASH), a liver condition linked to metabolic issues. The study aims to assess the safety of HU6 and its impact on liver fat levels. Participants will receive either a low or high dose of the treatment or a placebo for comparison. Ideal candidates have a MASH diagnosis and a body mass index (BMI) between 27 and 44, indicating they are overweight. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant medical advancements.

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

Yes, you may need to stop certain medications. The trial excludes participants using specific medications like high-dose vitamin E, certain diabetes medications, weight loss drugs, and others. It's best to discuss your current medications with the trial team to see if they are allowed.

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

Research has shown that HU6 is generally safe for humans. Studies comparing HU6 to a placebo in people with non-alcoholic fatty liver disease (NAFLD) have yielded promising results. Participants taking HU6 experienced significant reductions in liver fat. Specifically, those taking doses of 150 mg, 300 mg, and 450 mg saw average decreases in liver fat of 26.8%, 35.6%, and 33.0%, respectively.

While these reductions in liver fat are encouraging, the safety of HU6 remains crucial. In these studies, HU6 was generally safe with no unexpected side effects. Researchers specifically examined safety and tolerance, finding no major negative effects. This suggests that HU6, in these doses, is well-tolerated by patients with NAFLD.12345

Why do researchers think this study treatment might be promising for fatty liver disease?

Researchers are excited about HU6 for fatty liver disease because it represents a novel approach compared to current treatments. Most existing options focus on lifestyle changes or medications that aim to improve insulin sensitivity or reduce lipid levels indirectly. HU6, however, works differently by targeting mitochondrial uncoupling, which could directly enhance energy expenditure and reduce liver fat more efficiently. This unique mechanism of action offers hope for potentially faster and more effective results in managing fatty liver disease.

What evidence suggests that HU6 might be an effective treatment for fatty liver disease?

Research has shown that HU6 may help reduce liver fat in people with fatty liver disease. One study found that participants taking HU6 experienced a decrease in liver fat by 26.8% to 35.6%, depending on the dose. In this trial, participants will receive either HU6 at different dosages or a placebo. In contrast, those who took a placebo in previous studies experienced an increase in liver fat. HU6 helps the body burn fat more efficiently. These encouraging results suggest that HU6 could effectively treat fatty liver disease and its related issues.12346

Who Is on the Research Team?

SM

Stefanie Mason, MD

Principal Investigator

Rivus Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

This trial is for adults aged 30 and older who have been diagnosed with metabolic dysfunction-associated steatohepatitis (MASH) and have a BMI between 27 and 44. Women must not be pregnant or breastfeeding, and must use effective birth control during the study.

Inclusion Criteria

I am 30 years old or older.
I have been diagnosed with MASH (metabolic dysfunction-associated steatohepatitis).
* Women of childbearing potential must not be pregnant or breastfeeding and must use and agree to continue to use a highly effective contraceptive method throughout time on study.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Blinded Intervention

Participants receive either HU6 or placebo in a double-blind manner

12 weeks
Weekly visits (in-person)

End of Treatment/Early Termination

Final assessment of participants who complete or terminate early from the blinded intervention

Safety Follow-up

Participants are monitored for safety after the end of treatment

4 weeks
1 visit (in-person)

Long-term Follow-up

Participants are monitored for long-term safety and efficacy

6 months
2 visits (in-person)

Open-label Extension (optional)

Participants may opt into continuation of treatment with HU6 long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

  • HU6

Trial Overview

The study compares HU6, a new medication, to a placebo in people with MASH. Participants are randomly assigned to receive either HU6 or an inactive pill to see how safe it is and if it helps reduce liver fat.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: HU6 450 mgExperimental Treatment1 Intervention
Group II: HU6 300 mgExperimental Treatment1 Intervention
Group III: Placebo Once DailyPlacebo Group1 Intervention
Group IV: Placebo Twice DailyPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rivus Pharmaceuticals, Inc.

Lead Sponsor

Trials
9
Recruited
540+

Citations

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.

2.

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.

Safety and efficacy of once-daily HU6 versus placebo in ...

HU6 is a drug with a novel mechanism of action that resulted in significant reductions in liver fat, together with reductions in bodyweight and other ...

Study met primary endpoint, with a statistically significant ...

Study met primary endpoint, with a statistically significant reduction in liver fat observed in all HU6 treatment groups. – Treatment with HU6 significantly ...

Safety and efficacy of once-daily HU6 versus placebo in ...

There were no deaths.INTERPRETATION: HU6 could be a promising pharmacological agent for treating patients with obesity and NAFLD and its metabolic complications ...

HU6 Reduces Liver Fat, Body Weight in Patients with ...

Participants treated with HU6 150 mg, 300 mg, and 450 mg experienced –26.8%, –35.6%, and –33.0% mean change in liver fat content from baseline ...