HU6 for Type 2 Diabetes with Risk of Fatty Liver Disease

Verified Trial

Phase 2

Recruiting

Research Sponsored by Rivus Pharmaceuticals, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure.

Willing and able to comply with the requirements of the study protocol.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Summary

This trial tests an experimental drug to treat obese people with type 2 diabetes and risk of NASH. Six months of dosing will be monitored for safety, efficacy, and more.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common ones associated with clinical trials like this could include gastrointestinal issues, headaches, fatigue, allergic reactions, and potential impacts on liver function which will be monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

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

Select...

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

Select...

I have type 2 diabetes.

Select...

You have tried to lose weight through dieting before, but it did not work for you.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent change from baseline in liver fat, as assessed by magnetic resonance imaging liver proton density fat fraction (MRI-Liver PDFF) at 6 months (26 weeks)

Secondary study objectives

Change from baseline in HbA1c at 6 months (26 weeks).

Percent change from baseline in body weight at 6 months (26 weeks)