Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists (NCT06640972) | Clinical Trial Compass
CompletedPhase 2
Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists
United States68 participantsStarted 2024-09-27
Plain-language summary
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
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Willing and able to provide written informed consent prior to the conduct of any study specific procedures;
✓. Planned or willing discontinuation of semaglutide or tirzepatide for the treatment of obesity prior to randomization (Visit T1/Day 1) through the end of study (EOS);
✓. Lost ≥10% or 10 kg of original (pre-GLP-1 baseline) body weight with semaglutide or tirzepatide;
✓. Males and females aged 18 to 65 years (both inclusive) at Screening (Visit S1);
✓. A hemoglobin A1C (HbA1c) of \<6.5% at Screening (Visit S1);
✓. A 12-lead (electrocardiograph) ECG at Screening (Visit S1) which, in the opinion of the investigator, had no abnormalities that compromised safety in this study;
✓. Males and nonpregnant, nonlactating females. Females must be either of non-childbearing potential or use appropriate birth control methods and have a negative pregnancy test at Screening
. Recent (within 3 months prior to the Screening visit \[Visit S1\]) cardiovascular event or planned or recent cardiovascular surgery or intervention. Patients with implantable pacemakers or automatic implantable cardioverter defibrillators may be considered if deemed by the investigator to be stable for the previous 3 months;
✕. Uncontrolled hypertension, defined as systolic blood pressure (SBP) \>160 mmHg and diastolic blood pressure (DBP) \>100 millimeters of mercury (mmHg) after being in supine position for 5 minutes;
✕. Total fasting (minimum of 10 hours) TGs ≥400 milligrams per deciliter (mg/dL) (4.5 millimoles per liter (mmol/L)) at Screening (Visit S1);
✕. Fasting glucose \>126 mg/dL at Screening (Visit S1);
✕. Uncontrolled hypothyroidism, including thyroid stimulating hormone (TSH) \>1.5 × the upper limit of normal (ULN) at Screening (Visit S1); patients stabilized on thyroid replacement therapy for at least 6 weeks prior to randomization (Visit T1/Day 1) are allowed; Liver disease or dysfunction, including positive serology or hepatitis B and/or C or significant elevations in certain liver function tests
✕. Renal dysfunction or glomerulonephritis, including estimated glomerular filtration rate (eGFR; using the Chronic Kidney Disease Epidemiology Collaboration \[CKD-EPI\] 2021 formula) \<60 milliliters per minute (mL/min) at Screening (Visit S1).
✕. Gastrointestinal conditions or procedures (including weight loss surgery; e.g., Lap-Band® or gastric bypass) except uncomplicated cholecystectomy and appendectomy that may affect drug absorption;