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

Sponsor
NodThera Limited (Industry)
Overall Status
Recruiting
CT.gov ID
NCT06129409
Collaborator
(none)
69
Enrollment
2
Locations
2
Arms
5.7
Anticipated Duration (Months)
34.5
Patients Per Site
6
Patients Per Site Per Month

Study Details

Study Description

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
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

Study Type:
Interventional
Anticipated Enrollment :
69 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Drug vs PlaceboDrug 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 :
Oct 10, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Apr 1, 2024

Arms and Interventions

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

Primary Outcome Measures

  1. Change in hsCRP levels [Baseline to Day 28]

    Evaluate the effects of NT-0796 on inflammation.

Secondary Outcome Measures

  1. Change in Body weight (kg) [Change from baseline to Day 28]

  2. Body composition [Change from baseline to Day 28]

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

Other Outcome Measures

  1. Clinical laboratory values [Change from baseline to Day 28]

    Haematology and Clinical Chemistry

  2. Vital signs [Change from baseline to Day 28]

    Body temperature, heart rate and systolic and diastolic blood pressure

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Investigative Site Miami Florida United States 33147
2 Investigative Site Austin Texas United States 78744

Sponsors and Collaborators

  • NodThera Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NodThera Limited
ClinicalTrials.gov Identifier:
NCT06129409
Other Study ID Numbers:
  • NT-0796-P003
First Posted:
Nov 13, 2023
Last Update Posted:
Nov 13, 2023
Last Verified:
Oct 1, 2023
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cardiovascular Diseases

Study Results

No Results Posted as of Nov 13, 2023