The goal of this clinical trial is to learn if drug RDX-002 works to treat high levels of fat (known as triglycerides, or TGs) in the blood in adults. It will also learn about the safety of drug RDX-002. The main question it aims to answer is if treatment with RDX-002 will lower triglycerides after a high-fat meal in patients who have recently stopped treatment with semaglutide or tirzepatide for obesity. The trial will also examine the effect of RDX-002 on body weight and fasting levels of cholesterol. Researchers will compare RDX-002 to a placebo (a look-alike substance that contains no drug) to see if RDX-002 works to reduce triglycerides. Participants will: Take drug RDX-002 or a placebo every day for 12 weeks Visit the clinic once every 4 weeks for checkups and tests
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study that will be conducted at a single study site in the United States (US). Patients who have planned discontinuation of semaglutide or tirzepatide treatment for obesity, have lost ≥10% or 10 killigrams (kg) of their original body weight and are aged 18 to 65 years will be eligible for Screening. The study will assess the efficacy of 12 weeks of treatment with 200 mg twice daily (BID) RDX-002 or placebo on the mean percentage change from baseline on postprandial triglycerides (TGs) among patients who have recently discontinued treatment with semaglutide or tirzepatide for obesity. The trial will also examine the impact of RDX-002 on body weight and fasting levels of cholesterol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
68
Nucleus Network
Saint Paul, Minnesota, United States
Incremental Postprandial Triglycerides (TG)
Mean percent change in incremental TG area under the curve (AUC) from baseline to week 12. Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.
Time frame: 12 weeks
Total Postprandial TG
Mean percent change in total postprandial TG AUC from baseline to week 12.Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.
Time frame: 12 weeks
Body Weight
Mean percent change in body weight from baseline to week 12. Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.
Time frame: 12 weeks
5% Increase in Body Weight
Percentage of patients exhibiting at least a 5% increase from baseline to Week 12.
Time frame: 12 weeks
LDL-C
Mean percent change from baseline to week 12. Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.
Time frame: 12 weeks
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