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HU6 for Type 2 Diabetes and Obesity

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights

Study Summary

This trial is testing a drug to see if it helps people with overweight/obesity and type 2 diabetes; it's monitored for safety and effectiveness.

Who is the study for?
This trial is for adults aged 18 to 70 who are overweight or obese with Type 2 Diabetes (BMI >28.0 kg/m2). Participants must understand the study, consent to it, and fit into an MRI machine. They shouldn't exercise more than 3 hours a week or have had significant weight changes (>5% gain/loss) in the last three months.Check my eligibility
What is being tested?
The trial is testing HU6's effects on energy metabolism, muscle and liver substrate metabolism, and mitochondrial function in subjects with obesity and Type 2 Diabetes. It's a randomized, double-blind study comparing HU6 against a placebo over four stages.See study design
What are the potential side effects?
Potential side effects of HU6 aren't specified here but could include reactions typical of metabolic treatments such as gastrointestinal discomfort, changes in blood sugar levels, fatigue, or other metabolic disturbances.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sleeping Metabolic Rate (SMR) change from Baseline to 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 HU6Experimental Treatment1 Intervention
Subjects who are randomized to active study drug will receive 450mg of HU6 for 14 day and then 600mg of HU6 for 168 days. N = 24
Group II: PlaceboPlacebo Group1 Intervention
Placebo Comparator is non-active study drug. N = 24
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
554 Total Patients Enrolled
Rachel Garner, PhDStudy DirectorRivus Pharmaceuticals, Inc.

Frequently Asked Questions

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

Who has the opportunity to participate in this clinical experiment?

"Eligibility for this clinical study requires patients to have Type 2 diabetes and be between 18-70 years old. This trial is accepting 48 individuals in total."

Answered by AI

Is the age cutoff for this trial higher than twenty-five years old?

"This clinical trial is accepting participants aged 18 to 70. Separately, 246 trials are being conducted for minors and 1436 studies are dedicated to those older than 65 years old."

Answered by AI

Has the FDA approved Active Treatment HU6 for medical use?

"Our team at Power believes that Active Treatment HU6 has a safety rating of 2, as it is currently in Phase 2 testing and there exists no data for efficacy but some supporting its safety."

Answered by AI

Are there still opportunities for volunteers to participate in the trial?

"Unfortunately, the study is no longer recruiting patients. According to clinicaltrials.gov, this investigation was first posted on November 1st 2023 and its last edit occurred October 23rd of that same year. However, there are plenty of other trials with open recruitment at present; 2001 in total!"

Answered by AI

Who else is applying?

What site did they apply to?
AdventHealth Translational Research Institute
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Ph 2a Study of HU6 on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function in Subjects Who Are Overweight or Obese With Type 2 Diabetes
2023. "Ph 2a Study of HU6 on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function in Subjects Who Are Overweight or Obese With Type 2 Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06104358.
~0 spots leftby Feb 2025
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