67 Participants Needed

Exploratory Ph 2A, Double-Blind, Placebo-Controlled Dose Escalation Study of Safety, Tolerability, PD, & PK of HU6 for Subjects With Obese HFpEF

(HFpEF Trial)

Recruiting at 14 trial locations
CM
JP
SB
JD
Overseen ByJanice Durden
Age: 18+
Sex: Any
Travel: May Be Covered
Trial Phase: Phase 2
Sponsor: Rivus Pharmaceuticals, Inc.
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants have stable doses of their current medications for at least 30 days before screening, meaning no new medications or significant changes in dosage. If you are on diuretics, you must be on a stable regimen that allows for flexible dosing.

What safety data exists for the treatment evaluated under names like HU6, Placebo, Control, and Dummy Treatment?

The safety reporting in clinical trials is often inadequate, with only a small percentage of trials providing detailed information on adverse effects and reasons for withdrawal due to toxicity. Placebos, often used in trials, are not always harmless as their contents are not always inert, which can affect safety data interpretation.12345

What makes the drug HU6 unique compared to other treatments?

The drug HU6 is unique because it is a synthetic cannabinoid that acts as a non-competitive NMDA receptor blocker, providing pain relief without the psychotropic effects typically associated with cannabinoids. This mechanism of action, combined with its ability to scavenge free radicals, makes it distinct from other treatments.678910

What is the purpose of this trial?

This trial tests a new drug called HU6 by giving participants increasing doses to find the safest and most effective amount. It involves individuals who meet specific health criteria.

Research Team

SK

Shaharyar Khan, PhD

Principal Investigator

Rivus Pharmaceuticals, Inc.

Eligibility Criteria

Inclusion Criteria

Adult male or female, ≥40 years of age.
Competent to understand the information given in the Institutional Review Board (IRB) or Independent Ethics Committee (IEC) approved Informed Consent Form (ICF) and must sign the form prior to the initiation of any study procedures.
You have to meet at least one of the following criteria for heart failure:
See 3 more

Exclusion Criteria

You have a currently active autoimmune disease affecting your connective tissues.
You have a specific type of heart condition called primary cardiomyopathy as determined by the doctor.
You have a current case of heart inflammation, either caused by COVID or another reason.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

40 days
1-2 visits (in-person)

Treatment

Participants receive HU6 or placebo in a dose escalation manner: 150 mg daily for 20 days, followed by 300 mg daily for 20 days, and 450 mg daily for 94 days if safety and tolerability are demonstrated.

134 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks
1 visit (in-person)

Treatment Details

Interventions

  • HU6
  • Placebo
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Treatment: HU6 Planned doses of HU6; N = 31Experimental Treatment1 Intervention
Group II: Placebo Comparator Non-active study drug N = 31Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Rivus Pharmaceuticals, Inc.

Lead Sponsor

Trials
9
Recruited
540+

Findings from Research

A review of 192 randomized clinical trials revealed that safety information is often underreported, with only 46% specifying reasons for withdrawals due to toxicity and only 39% adequately reporting clinical adverse effects.
To enhance safety reporting, the study emphasizes the need for standardized scales for adverse effects, systematic data collection, and detailed reporting of severe reactions, suggesting that improved practices could lead to better safety insights in clinical trials.
Improving safety reporting from randomised trials.Ioannidis, JP., Lau, J.[2018]
The study systematically analyzed placebo effects from randomized, placebo-controlled trials, revealing that while placebos can influence clinical symptoms, they do not affect laboratory values like blood glucose in diabetics.
Placebo side effects were found to be similar to those of active treatments, highlighting the importance of careful placebo use in clinical research to ensure patient safety and informed consent.
Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis.Weihrauch, TR.[2019]
In a review of 113 placebo-controlled randomized clinical trials published in 2016, only 19.5% of journal articles and 45.1% of study protocols provided descriptions of placebo contents, highlighting a significant lack of transparency in clinical trial reporting.
None of the journal publications explained the rationale for the choice of placebo ingredients, which raises concerns about the potential effects of active placebos on trial outcomes and complicates the assessment of the safety and efficacy of experimental interventions.
Definition and rationale for placebo composition: Cross-sectional analysis of randomized trials and protocols published in high-impact medical journals.Hong, K., Rowhani-Farid, A., Doshi, P.[2023]

References

Improving safety reporting from randomised trials. [2018]
Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. [2019]
Definition and rationale for placebo composition: Cross-sectional analysis of randomized trials and protocols published in high-impact medical journals. [2023]
Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Trial Assessing the Effects of Applying a Force to C5 by a Mechanically Assisted Instrument on Referred Pain to the Shoulder. [2021]
TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. [2020]
Suppression of neuropathic pain behavior in rats by a non-psychotropic synthetic cannabinoid with NMDA receptor-blocking properties. [2021]
Behavioral effects of cannabinoids show differential sensitivity to cannabinoid receptor blockade and tolerance development. [2022]
Neuroprotective and antioxidant activities of HU-211, a novel NMDA receptor antagonist. [2019]
Cannabimimetic activity in rats and pigeons of HU 210, a potent antiemetic drug. [2019]
10.United Statespubmed.ncbi.nlm.nih.gov
Protection against septic shock and suppression of tumor necrosis factor alpha and nitric oxide production by dexanabinol (HU-211), a nonpsychotropic cannabinoid. [2016]
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