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

• Status: Completed
• Trial end date: 2024-04-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NodThera Limited

Criteria

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