New pill aims to prevent fat spike after Weight-Loss drug stop
NCT ID NCT06640972
First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 2 times
Summary
This study tested whether the drug RDX-002 can lower high blood fat levels in people who recently stopped taking weight-loss medications like semaglutide or tirzepatide. Sixty-eight adults who had lost at least 10% of their body weight on those drugs took either RDX-002 or a placebo daily for 12 weeks. The main goal was to see if RDX-002 reduces triglycerides after a fatty meal, while also checking effects on weight and cholesterol.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RDX-002 (a drug that blocks fat absorption in the gut)
- What this could lead to
- If it works, RDX-002 could help people maintain healthier blood fat levels after stopping popular weight-loss injections.
- What could go wrong
- This is a small, early-phase trial with only 68 participants. The drug may not work better than placebo, and side effects from blocking fat absorption are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
68 people
The number who actually took part.
- Started
-
Sep 2024
- Finished
-
May 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Nucleus Network
Saint Paul, Minnesota, 55114, United States
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Other studies related to the condition(s) this trial covers.
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