Effects of NT-0796 in Obese Participants at Risk of Cardiovascular Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Cardiovascular Diseases

Intervention / Treatment
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* Drug: NT-0796


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female aged 18 years or older. Body mass index (BMI) ≥30 and ≤40 kg/m2 at screening. Presence of 1 or more of the following risk factors for atherosclerotic cardiovascular disease: History of controlled hypertension History of hypercholesterolemia History of high-density lipoprotein levels Controlled Type 1 or Type 2 Diabetes mellitus Exclusion Criteria: History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months History of acute coronary syndrome (ACS) Stable angina. Diagnosis of congestive heart failure Evidence of past or current infection with Hepatitis B or Hepatitis C

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Drug vs Placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NT-0796<br>BID | Drug: NT-0796<br>* Orally administered capsules<br>|
| Placebo Comparator: Placebo<br>BID | Drug: NT-0796<br>* Orally administered capsules<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hsCRP levels | Evaluate the effects of NT-0796 on inflammation. | Baseline to Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body weight (kg) |  | Change from baseline to Day 28 | 
| Body composition | Absolute Fat mass, % Body Fat and Visceral Fat (L) | Change from baseline to Day 28 |