Effects of NT-0796 in Obese Participants at Risk of Cardiovascular Disease
NCT06129409 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67
Last updated 2024-12-16
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.
Conditions
Interventions
- DRUG
-
NT-0796
Orally administered capsules
Sponsors & Collaborators
-
NodThera Limited
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-10-10
- Primary Completion
- 2024-04-15
- Completion
- 2024-04-15
- FDA Drug
- Yes
Countries
- United States
Study Locations
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