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

NCT ID: NCT06129409

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-10

Study Completion Date

2024-04-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cardiovascular Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Drug vs Placebo
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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NT-0796

BID

Group Type EXPERIMENTAL

NT-0796

Intervention Type DRUG

Orally administered capsules

Placebo

BID

Group Type PLACEBO_COMPARATOR

NT-0796

Intervention Type DRUG

Orally administered capsules

Interventions

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NT-0796

Orally administered capsules

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NodThera Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigative Site

Miami, Florida, United States

Site Status

Investigative Site

Austin, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NT-0796-P003

Identifier Type: -

Identifier Source: org_study_id