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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
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
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I am 18 years old or older.
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I am not pregnant or breastfeeding and will use effective birth control during the study.
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I agree to use contraception during and 90 days after the study if I haven't had a confirmed vasectomy.
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I have type 2 diabetes.
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You have tried to lose weight through dieting before, but it did not work for you.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change from baseline in HbA1c at 6 months (26 weeks).
Percent change from baseline in body weight at 6 months (26 weeks)

Side effects data

From 2021 Phase 2 trial • 80 Patients • NCT04874233
42%
Flushing
32%
Diarrhoea
16%
Palpitations
16%
Night sweats
11%
Dizziness
11%
Abdominal Pain
5%
Nausea
5%
Myalgia
5%
Vessel puncture site haemorrhage
5%
Oropharyngeal pain
5%
Decreased appetite
5%
Presyncope
5%
Rhinitis
5%
Arthralgia
5%
Fatigue
5%
Dyspnoea
5%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active: HU6 450mg
Active: HU6 150mg
Active: HU6 300mg
Placebo Comparator

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Treatment: HU6 Planned doses of HU6Experimental Treatment1 Intervention
Group II: Placebo Comparator Non-active study drugPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
HU6
2021
Completed Phase 2
~180

Find a Location

Who is running the clinical trial?

Rivus Pharmaceuticals, Inc.Lead Sponsor
7 Previous Clinical Trials
274 Total Patients Enrolled
3 Trials studying Non-alcoholic Fatty Liver Disease
174 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Diane Jorkasky, MDStudy DirectorRivus Pharmaceuticals, Inc.

Media Library

HU6 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05979779 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Active Treatment: HU6 Planned doses of HU6, Placebo Comparator Non-active study drug
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: HU6 Highlights & Side Effects. Trial Name: NCT05979779 — Phase 2
HU6 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05979779 — Phase 2
Non-alcoholic Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT05979779 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there a great number of locations conducting this experiment in Canada?

"The six sites recruiting for this trial include Southwest General Healthcare Center in Fort Myers, Panax Clinical Research in Miami Lakes, and Advanced Clinical Research in Miami. Additionally, there are three other medical centres facilitating patient enrolment."

Answered by AI

Is recruitment still ongoing for this experiment?

"Unfortunately, according to clinicaltrials.gov, this medical experiment is not onboarding new patients at the time of writing. The trial was initially posted on August 1st 2023 and last edited a month later before ceasing recruitment efforts; however there are 2671 other studies actively enrolling participants right now."

Answered by AI

Has the FDA approved Active Treatment: HU6 Planned doses of HU6?

"Our team assessed the safety of Active Treatment: HU6 Planned doses of HU6 to be a 2, due to its Phase 2 trial status. That is, while there has been some research indicating this medication's security profile, no findings have yet corroborated efficacy."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
IMA Clinical Research-Austin
Eagle Clinical Research
Other
Mt Olympus Medical Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+
0

Why did patients apply to this trial?

I would like to have a better control of my diabetes. I've tried other drugs but nothing has helped my condition.
PatientReceived no prior treatments
Finding effective treatments as a VA patient requires one to be proactive..
PatientReceived 1 prior treatment
I have had liver cancer twice in the past year. Ablation was done on 01/12/23 and 12/26/23.
PatientReceived no prior treatments
I don't drink alcohol, yet have been diagnosed with Fatty Liver. I've tried clensing with herb and flower tea and others but nothing seems to do anything. I even have bone broth for lunch but again I am just too fat to be healthy. Fix me or let me go.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Most responsive sites:
  1. Mt Olympus Medical Research: < 48 hours
Average response time
  • < 2 Days
Recent research and studies
clinicaltrials.govStudy
Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Obese Subjects With Type 2 Diabetes at Risk of Nonalcoholic Steatohepatitis
2023. "Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Obese Subjects With Type 2 Diabetes at Risk of Nonalcoholic Steatohepatitis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05979779.
All > Fatty Liver Disease > Fargo
~102 spots leftby Sep 2024
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