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

November 8, 2023 updated by: NodThera Limited

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

69

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33147
        • Recruiting
        • Investigative Site
    • Texas
      • Austin, Texas, United States, 78744
        • Recruiting
        • Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
BID
Drug: NT-0796
Orally administered capsules
Experimental: NT-0796
BID
Drug: NT-0796
Orally administered capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in hsCRP levels
Time Frame: Baseline to Day 28
Evaluate the effects of NT-0796 on inflammation.
Baseline to Day 28

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Body weight (kg)
Time Frame: Change from baseline to Day 28
Change from baseline to Day 28
Body composition
Time Frame: Change from baseline to Day 28
Absolute Fat mass, % Body Fat and Visceral Fat (L)
Change from baseline to Day 28

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical laboratory values
Time Frame: Change from baseline to Day 28
Haematology and Clinical Chemistry
Change from baseline to Day 28
Vital signs
Time Frame: Change from baseline to Day 28
Body temperature, heart rate and systolic and diastolic blood pressure
Change from baseline to Day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NodThera Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 10, 2023

Primary Completion (Estimated)

April 1, 2024

Study Completion (Estimated)

April 1, 2024

Study Registration Dates

First Submitted

October 30, 2023

First Submitted That Met QC Criteria

November 8, 2023

First Posted (Estimated)

November 13, 2023

Study Record Updates

Last Update Posted (Estimated)

November 13, 2023

Last Update Submitted That Met QC Criteria

November 8, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NT-0796-P003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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