Study Stopped
The protocol was redirected by the FDA to another division and will be resubmitted at a future date.
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
A 6-Month, Randomized, Double-Blind, Placebo-controlled, Phase 2a Study of the Effects of HU6 on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function in Subjects Who Are Overweight or Obese With Type 2 Diabetes
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This is a randomized, double-blind, placebo-controlled parallel group study of HU6 and placebo in subjects who are overweight or obese with T2D. The study will be conducted in 4 stages.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2023
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 11, 2023
CompletedFirst Posted
Study publicly available on registry
October 27, 2023
CompletedStudy Start
First participant enrolled
November 17, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedJanuary 9, 2024
January 1, 2024
1.2 years
October 11, 2023
January 5, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Sleeping Metabolic Rate (SMR) change from Baseline to 6 Months (26 weeks)
Change from baseline in SMR at 6 months (26 weeks) as assessed by whole room indirect calorimetry (WRIC).
26 weeks
Study Arms (2)
Active Treatment HU6
EXPERIMENTALSubjects 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
Placebo
PLACEBO COMPARATORPlacebo Comparator is non-active study drug. N = 24
Interventions
HU6 is being evaluated for its effect on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function
Eligibility Criteria
You may qualify if:
- 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.
- Male or female 18 to 70 years of age, inclusive, at time of informed consent.
- Body mass index (BMI) \>28.0 kg/m2 and able to fit into the MRI machine.
- Subject has T2D meeting all of the following criteria:
You may not qualify if:
- Body weight \>450 pounds.
- Subject-reported history of weight gain or loss \>5% in 3 months prior to screening.
- The subject participates in programmed exercise \>3 hours per week.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AdventHealth Translational Research Institute
Orlando, Florida, 32804, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Rachel Garner, PhD
Rivus Pharmaceuticals, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2023
First Posted
October 27, 2023
Study Start
November 17, 2023
Primary Completion
February 1, 2025
Study Completion
March 1, 2025
Last Updated
January 9, 2024
Record last verified: 2024-01