Cardiovascular Diseases
Conditions
Brief summary
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
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.
Interventions
DRUGNT-0796
Orally administered capsules
Sponsors
NodThera Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Drug vs Placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female aged 18 years or older. 2. Body mass index (BMI) ≥30 and ≤40 kg/m2 at screening. 3. 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
1. History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months 2. History of acute coronary syndrome (ACS) 3. Stable angina. 4. Diagnosis of congestive heart failure 5. Evidence of past or current infection with Hepatitis B or Hepatitis C
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hsCRP levels | Baseline to Day 28 | Evaluate the effects of NT-0796 on inflammation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body weight (kg) | Change from baseline to Day 28 | — |
| Body composition | Change from baseline to Day 28 | Absolute Fat mass, % Body Fat and Visceral Fat (L) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical laboratory values | Change from baseline to Day 28 | Haematology and Clinical Chemistry |
| Vital signs | Change from baseline to Day 28 | Body temperature, heart rate and systolic and diastolic blood pressure |
Countries
United States
Outcome results
None listed