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

Phase 1

Completed

• Conditions: Cardiovascular Diseases
• Interventions: Drug: NT-0796

• Registration Number: NCT06129409
• Lead Sponsor: NodThera Limited

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.

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 Timeline

• Study Start: 2023-10-10
• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-11-08
• Study First Posted: 2023-11-13
• Primary Completion: 2024-04-15
• Study Completion: 2024-04-15
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-11
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	NT-0796	BID
NT-0796	NT-0796	BID

Primary Outcome Measures

Name	Time	Method
Change in hsCRP levels	Baseline to Day 28	Evaluate the effects of NT-0796 on inflammation.

Secondary Outcome Measures

Name	Time	Method
Change in Body weight (kg)	Change from baseline to Day 28
Body composition	Change from baseline to Day 28	Absolute Fat mass, % Body Fat and Visceral Fat (L)

Trial Locations

Locations (1)

Investigative Site; 🇺🇸 Austin, Texas, United States