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HU6 for Type 2 Diabetes with Risk of Fatty Liver Disease

Verified Trial
Phase 2
Waitlist Available
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
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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

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

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%
Decreased appetite
5%
Nausea
5%
Dyspnoea
5%
Presyncope
5%
Fatigue
5%
Pyrexia
5%
Vessel puncture site haemorrhage
5%
Oropharyngeal pain
5%
Rhinitis
5%
Myalgia
5%
Arthralgia
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
~250

Find a Location

Who is running the clinical trial?

Rivus Pharmaceuticals, Inc.Lead Sponsor
8 Previous Clinical Trials
319 Total Patients Enrolled
Rob Schott, MDStudy DirectorRivus Pharmaceuticals, Inc.
Diane Jorkasky, MDStudy DirectorRivus Pharmaceuticals, Inc.

Media Library

HU6 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05979779 — Phase 2
Fatty Liver Disease Research Study Groups: Active Treatment: HU6 Planned doses of HU6, Placebo Comparator Non-active study drug
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
Fatty Liver Disease Patient Testimony for trial: Trial Name: NCT05979779 — Phase 2
~14 spots leftby Feb 2025
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