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
Overview
- Phase
- Phase 1
- Intervention
- NT-0796
- Conditions
- Cardiovascular Diseases
- Sponsor
- NodThera Limited
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- Change in hsCRP levels
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
NT-0796
BID
Intervention: NT-0796
Placebo
BID
Intervention: NT-0796
Outcomes
Primary Outcomes
Change in hsCRP levels
Time Frame: Baseline to Day 28
Evaluate the effects of NT-0796 on inflammation.
Secondary Outcomes
- Change in Body weight (kg)(Change from baseline to Day 28)
- Body composition(Change from baseline to Day 28)