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

NodThera Limited

Status and phase: Completed; Phase 1

Conditions: Cardiovascular Diseases

Treatments: Drug: NT-0796

Study type: Interventional

Funder types: Industry

Identifiers

NCT06129409

NT-0796-P003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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67 participants in 2 patient groups, including a placebo group

NT-0796

Experimental group

Description:

BID

Treatment:

Drug: NT-0796

Placebo

Placebo Comparator group

Description:

BID

Treatment:

Drug: NT-0796