Status:
WITHDRAWN
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
Lead Sponsor:
Rivus Pharmaceuticals, Inc.
Conditions:
Diabete Type 2
Obesity
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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.
Detailed Description
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 (Figure 1). *...
Eligibility Criteria
Inclusion
- 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:
Exclusion
- 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.
Key Trial Info
Start Date :
November 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06104358
Start Date
November 17 2023
End Date
March 1 2025
Last Update
January 9 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
AdventHealth Translational Research Institute
Orlando, Florida, United States, 32804