← Trials/Trial dossier/NCT06640972

CompletedPhase 2

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

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

NCT IDNCT06640972
Org study IDRDX-002-024-011

Timeline

Milestones

Study start2024-09-27actual
Study first posted2024-10-15actual
Primary completion2025-01-04actual
Study completion2025-05-13actual
Last update posted2025-12-23actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersNot accepted

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
Cardiometabolic biomarkers
2

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Change in mean percent body weight

Time frame:12 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in body weight by 5%

Time frame:12 Weeks

≥5% weight-loss responders

threshold achievement, improvement

Cardiometabolic biomarkers

2 endpoints
Primary/protocol endpoint

Triglycerides

Time frame:12 weeks

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

LDL-C

Time frame:12 weeks

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.