HU6 for Type 2 Diabetes with Risk of Fatty Liver Disease

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

219 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a phase 2 randomized, double-blind, placebo-controlled parallel group study of 3 dose levels of HU6 in subjects with nonalcoholic steatohepatitis (NASH). Six months (26 weeks) of dosing is planned, and subjects will be followed for safety, efficacy, pharmacodynamics (PD), and pharmacokinetics (PK) during this time. The end-of-study visit will take place approximately 4 weeks after the last dose of the study drug (Week 30).

Research Team

Rob Schott, MD

Principal Investigator

Rivus Pharmaceuticals, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+