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Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of RDX-002 on Postprandial Triglycerides in Patients Discontinuing the Glucagon-like Peptide-1 (GLP-1) Agonists, Semaglutide or Tirzepatide, for the Treatment of Obesity
Lead sponsor
Assets
Semaglutide / Tirzepatide
Listed sites
1
Recruiting sites
—
Enrollment
68
actual
Study population
Obesity / overweight
Key I/E criterion
•HbA1c ≤6.5%
Primary endpoint
•Triglycerides, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Willing and able to provide written informed consent prior to the conduct of any study specific procedures;
2. 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);
3. Lost ≥10% or 10 kg of original (pre-GLP-1 baseline) body weight with semaglutide or tirzepatide;
4. Males and females aged 18 to 65 years (both inclusive) at Screening (Visit S1);
5. A hemoglobin A1C (HbA1c) of <6.5% at Screening (Visit S1);
6. 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;
7. 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
Exclusion criteria
1. Type 1 or Type 2 diabetes;
2. 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;
3. 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;
4. Total fasting (minimum of 10 hours) TGs ≥400 milligrams per deciliter (mg/dL) (4.5 millimoles per liter (mmol/L)) at Screening (Visit S1);
5. Fasting glucose >126 mg/dL at Screening (Visit S1);
6. 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
7. 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).
8. 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;
9. Known history of hematologic or coagulation disorders or a hemoglobin level <10.0 grams/deciliter (g/dL) at Screening (Visit S1);
10. Active malignancy, including those requiring surgery, chemotherapy, and/or radiation in the past 5 years. Nonmetastatic basal or squamous cell carcinoma of the skin and cervical carcinoma in situ are allowed;
11. Unexplained creatine kinase (CK) >3 × ULN at any time prior to randomization (i.e., not associated with recent trauma or physically strenuous activity). Patients with an explained CK elevation must have single repeat CK ≤3 × ULN prior to randomization;
12. History of drug or alcohol abuse within the last 2 years or reported current consumption of >14 alcoholic drinks/week, or any illicit drug use (checked positive for standard drug screening panel). Patients testing positive for tetrahydrocannabinol (THC) (whether prescribed or not) and for amphetamine derivatives prescribed by and under the care of a health care practitioner (except for weight management) can be enrolled after evaluation and at the discretion of the investigator;
13. Inability to follow the required minimum 2 meals a day, or unwillingness to consume meal on both study test occasions, or inability to fast, as required during the study;
14. Blood donation, participation in multiple blood draws, clinical study, major trauma, blood transfusion or surgery with or without blood loss within 30 days prior to randomization (Visit T1/Day 1);
15. Use of any experimental or investigational drugs except GLP-1 agonists within 30 days or 5 half-lives (whichever is longer) prior to Screening (Visit S1);
16. Use of any prohibited diabetes or other weight loss drugs prior to or during the study (as specified) unless meeting specific rescue criteria:
17. Recent (within 30 days unless otherwise specified) initiation or discontinuation of lipid-lowering medications. Consistent background use is allowed;
18. An employee or contractor of the facility conducting the study, or a family member of the principal investigator, co-investigator, or any Sponsor personnel;
19. Pregnant, breastfeeding, or intending to become pregnant within 30 days after study completion or last dose of study drug;
20. A medical or situational (i.e., geographical) finding that, in the investigator's opinion, may compromise the patient's safety or ability to complete the study.
Endpoints (4)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsChange in mean percent body weight
Time frame:12 weeks
Body weight, % change
percent change from baseline, improvement
Change in body weight by 5%
Time frame:12 Weeks
≥5% weight-loss responders
threshold achievement, improvement
Cardiometabolic biomarkers
2 endpointsTriglycerides
Time frame:12 weeks
Triglycerides, change
percent change from baseline, improvement
LOINC 2571-8
LDL-C
Time frame:12 weeks
LDL-C, change
percent change from baseline, improvement
LOINC 13457-7
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.