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New pill aims to prevent fat spike after Weight-Loss drug stop

NCT ID NCT06640972

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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.

Body-Weight Trajectory Hypercholesterolemia hyperlipidemia hypertriglyceridemia Obesity obesity disorder

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.