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

Cardiovascular Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06129409
• Other study ID #: NT-0796-P003
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 10, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: October 2023
• Source: NodThera Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Drug:
• NT-0796
Orally administered capsules

Locations

Country	Name	City	State
United States	Investigative Site	Austin	Texas
United States	Investigative Site	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
NodThera Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Clinical laboratory values	Haematology and Clinical Chemistry	Change from baseline to Day 28
Other	Vital signs	Body temperature, heart rate and systolic and diastolic blood pressure	Change from baseline to Day 28
Primary	Change in hsCRP levels	Evaluate the effects of NT-0796 on inflammation.	Baseline to Day 28
Secondary	Change in Body weight (kg)		Change from baseline to Day 28
Secondary	Body composition	Absolute Fat mass, % Body Fat and Visceral Fat (L)	Change from baseline to Day 28