This trial is a Randomized, Double-Blind (Sponsor-Open), Placebo-Controlled Study to Assess the Effect of NT-0796 on Inflammation in Obese Participants at Risk of Cardiovascular Disease. Participants will be admitted to an in-patient Clinical Research Unit on Day -1 and will be discharged on Day 30. The trial will include a 7-day out-patient safety follow-up period following the last dose of study treatment. For the first approximately 20 participants effect of food will be evaluated on the Pharmacokinetics of NT-0796. MRI's will be conducted in a subset of participants.
The goal of this clinical trial is to evaluate the effects of NT-0796 on inflammation in obese participants at risk of cardiovascular disease, evaluate the effects of NT-0796 on body weight and composition, to see how safe NT-0796 is, and how well it is tolerated and to measure the blood levels of NT-0796, with and without food.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
67
Orally administered capsules
Investigative Site
Miami, Florida, United States
Investigative Site
Austin, Texas, United States
Change in hsCRP levels
Evaluate the effects of NT-0796 on inflammation.
Time frame: Baseline to Day 28
Change in Body weight (kg)
Time frame: Change from baseline to Day 28
Body composition
Absolute Fat mass, % Body Fat and Visceral Fat (L)
Time frame: Change from baseline to Day 28
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