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

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ClinicalTrials.gov Identifier: NCT06129409
Recruitment Status : Recruiting
First Posted : November 13, 2023
Last Update Posted : November 13, 2023
Sponsor:
Information provided by (Responsible Party):
NodThera Limited

Study Description
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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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Drug: NT-0796 Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Drug vs Placebo
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 10, 2023
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: NT-0796
BID
 Drug: NT-0796
Orally administered capsules
Placebo Comparator: Placebo
BID
 Drug: NT-0796
Orally administered capsules


Outcome Measures
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Primary Outcome Measures :
  1. Change in hsCRP levels [ Time Frame: Baseline to Day 28 ]
    Evaluate the effects of NT-0796 on inflammation.


Secondary Outcome Measures :
  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 Outcome Measures:
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06129409


Contacts
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Contact: NodThera Ltd. 17815230151 ext 0151 Clinicaltrials@nodthera.com

Locations
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United States, Florida
Investigative Site Recruiting
Miami, Florida, United States, 33147
United States, Texas
Investigative Site Recruiting
Austin, Texas, United States, 78744
Sponsors and Collaborators
NodThera Limited
More Information
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Responsible Party: NodThera Limited
ClinicalTrials.gov Identifier: NCT06129409    
Other Study ID Numbers: NT-0796-P003
First Posted: November 13, 2023    Key Record Dates
Last Update Posted: November 13, 2023
Last Verified: October 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases