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
1 other identifier
interventional
67
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 cardiovascular-diseases
Started Oct 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2023
CompletedFirst Submitted
Initial submission to the registry
October 30, 2023
CompletedFirst Posted
Study publicly available on registry
November 13, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2024
CompletedDecember 16, 2024
December 1, 2024
6 months
October 30, 2023
December 11, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change in hsCRP levels
Evaluate the effects of NT-0796 on inflammation.
Baseline to Day 28
Secondary Outcomes (2)
Change in Body weight (kg)
Change from baseline to Day 28
Body composition
Change from baseline to Day 28
Other Outcomes (2)
Clinical laboratory values
Change from baseline to Day 28
Vital signs
Change from baseline to Day 28
Study Arms (2)
NT-0796
EXPERIMENTALBID
Placebo
PLACEBO COMPARATORBID
Interventions
Eligibility Criteria
You may qualify if:
- Male or female aged 18 years or older.
- Body mass index (BMI) ≥30 and ≤40 kg/m2 at screening.
- 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
You may not qualify if:
- History of stroke with residual neurological deficit within 2 years or transient ischemic attack within 6 months
- History of acute coronary syndrome (ACS)
- Stable angina.
- Diagnosis of congestive heart failure
- Evidence of past or current infection with Hepatitis B or Hepatitis C
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- NodThera Limitedlead
Study Sites (2)
Investigative Site
Miami, Florida, 33147, United States
Investigative Site
Austin, Texas, 78744, United States
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2023
First Posted
November 13, 2023
Study Start
October 10, 2023
Primary Completion
April 15, 2024
Study Completion
April 15, 2024
Last Updated
December 16, 2024
Record last verified: 2024-12