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Completed

NCT Number: NCT06129409

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

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.

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Key information

Conditions

Cardiovascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Investigative Site, Miami, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NT-0796

Drug

Orally administered capsules

Primary outcomes

  1. Change in hsCRP levels

    Time frame: Baseline to Day 28

    Evaluate the effects of NT-0796 on inflammation.

Secondary outcomes

  1. Change in Body weight (kg)

    Time frame: Change from baseline to Day 28

  2. Body composition

    Time frame: Change from baseline to Day 28

    Absolute Fat mass, % Body Fat and Visceral Fat (L)

Other outcomes

  1. Clinical laboratory values

    Time frame: Change from baseline to Day 28

    Haematology and Clinical Chemistry

  2. Vital signs

    Time frame: Change from baseline to Day 28

    Body temperature, heart rate and systolic and diastolic blood pressure

Sponsors and collaborators

Lead sponsor

NodThera Limited

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 13, 2023
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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