Effects of NT-0796 in Obese Participants at Risk of Cardiovascular Disease
Completed · Phase 1 · Has a placebo group
Conditions studied: Cardiovascular Diseases
In brief
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.
Key facts
- Study ID
- NCT06129409
- Run by
- NodThera Limited
- People needed
- 67
- Starts
- 2023-10-10
- Expected to finish
- 2024-04-15
- Last updated by the study team
- 2024-12-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- Investigative Site — Miami, Florida, United States
- Investigative Site — Austin, Texas, United States
Full record on ClinicalTrials.gov
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