Diabete Type 2, Obesity
Conditions
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). * Stage 1: (screening) is conducted over a 29-day window (Day -48 to Day -20). Subjects who meet all of the eligibility criteria may proceed Stages 2 to 4 of the study. * Stage 2 (baseline \[pre-randomization\]) is conducted over a 19-day period prior to randomization and includes a 13-day run-in and the first 6-day inpatient assessment period. At the end of Stage 2, subjects will be randomized 1:1 to HU6 or placebo. * Stage 3 (double-blind dosing) is conducted after randomization. Day 1 is the first dose of double-blind study drug, and dosing continues over an approximate 26-week period. During this time, there will be study visits for safety, PK, and PD. Stage 3 of the study concludes with a 3-day run-in followed by the second 6-day inpatient assessment period. * Stage 4 (washout) is conducted after dosing has ended and includes an approximate 4-week washout duration including a 3-day run-in followed by the third inpatient assessment period (3-day duration). The last day of the 3-day inpatient stay is the end-of-study. (Note that there will be a separate early termination visit for any subject who prematurely discontinues from the study
Interventions
DRUGHU6
HU6 is being evaluated for its effect on Energy Metabolism, Muscle and Liver Substrate Metabolism, and Mitochondrial Function
Sponsors
Rivus Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure. 2. Willing and able to comply with the requirements of the study protocol. 3. Male or female 18 to 70 years of age, inclusive, at time of informed consent. 4. Body mass index (BMI) \>28.0 kg/m2 and able to fit into the MRI machine. 5. Subject has T2D meeting all of the following criteria:
Exclusion criteria
1. Body weight \>450 pounds. 2. Subject-reported history of weight gain or loss \>5% in 3 months prior to screening. 3. The subject participates in programmed exercise \>3 hours per week.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleeping Metabolic Rate (SMR) change from Baseline to 6 Months (26 weeks) | 26 weeks | Change from baseline in SMR at 6 months (26 weeks) as assessed by whole room indirect calorimetry (WRIC). |
Countries
United States
Outcome results
None listed