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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NT-0796 | Experimental | BID |
|
| Placebo | Placebo Comparator | BID |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NT-0796 | Drug | Orally administered capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hsCRP levels | Evaluate the effects of NT-0796 on inflammation. | Baseline to Day 28 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical laboratory values | Haematology and Clinical Chemistry | Change from baseline to Day 28 |
| Vital signs | Body temperature, heart rate and systolic and diastolic blood pressure |
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:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigative Site | Miami | Florida | 33147 | United States | ||
| Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42187339 | Derived | Ray KK, Clarke N, Thornton P, Miles AE, Digby Z, Davies MJ, Gorman M, Mullen B, Reader V, Magill M, Johnstone H, Ariti C, Sattar N, Marx N, Navar AM, Hernandez AF, George JT, Watt AP, Butler J, Ridker PM. Anti-Inflammatory Effects of Oral NLRP3 Inhibition With Ruvonoflast Among Individuals at Elevated Cardiovascular Risk. J Am Coll Cardiol. 2026 May 26:S0735-1097(26)06570-8. doi: 10.1016/j.jacc.2026.05.014. Online ahead of print. |
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| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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Drug vs Placebo
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| Change from baseline to Day 28 |
| Austin |
| Texas |
| 78744 |
| United States |