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Effects of NT-0796 in Obese Participants at Risk of Cardiovascular Disease - Trial NCT06129409

Access comprehensive clinical trial information for NCT06129409 through Pure Global AI's free database. This Phase 1/2 trial is sponsored by NodThera Limited and is currently Recruiting. The study focuses on Cardiovascular Diseases. Target enrollment is 69 participants.

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NCT06129409
Phase 1/2
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06129409
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Effects of NT-0796 in Obese Participants at Risk of Cardiovascular Disease
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

Study Focus

Cardiovascular Diseases

NT-0796

Interventional

drug

Sponsor & Location

NodThera Limited

Miami,Austin, United States of America

Timeline & Enrollment

Phase 1/2

Oct 10, 2023

Apr 01, 2024

69 participants

Primary Outcome

Change in hsCRP levels

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.

ICD-10 Classifications

Cardiovascular disease, unspecified
Hypertensive heart disease
Other ill-defined heart diseases
Heart disease, unspecified
Observation for other suspected cardiovascular diseases

Data Source

ClinicalTrials.gov

NCT06129409

Non-Device Trial