HU6 for Fatty Liver Disease

(AMPLIFY Trial)

Recruiting at 32 trial locations

Overseen By VP, Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rivus Pharmaceuticals, Inc.

Must not be taking: Vitamin E, GLP-1 agonists, Insulin, others

Disqualifiers: Hepatitis, Malignancy, Cardiovascular conditions, others

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

Compensation: Varies

Number of Visits: 3

180 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Rivus Pharmaceuticals. Inc. is sponsoring this research study to assess the safety and tolerability of HU6 as a possible treatment for patients diagnosed with metabolic dysfunction-associated steatohepatitis (MASH). The study will also assess safety, pharmacokinetics (PK) and changes in liver fat content related to patients diagnosed with MASH.

Who Is on the Research Team?

Stefanie Mason, MD

Principal Investigator

Rivus Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

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.

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

How Is the Trial Designed?

Group I: HU6 450 mg Experimental Treatment 1 Intervention

450 mg Once Daily (QD)

Group II: HU6 300 mg Experimental Treatment 1 Intervention

300 mg Twice Daily (BID)

Group III: Placebo Once Daily Placebo Group 1 Intervention

Placebo Once Daily (QD)

Group IV: Placebo Twice Daily Placebo Group 1 Intervention

Placebo Twice Daily (BID)

Who Is Running the Clinical Trial?

Rivus Pharmaceuticals, Inc.

Lead Sponsor

Trials

9

Recruited

540+