Skip to content

Trial · Interventional

CompletedPhase 2Results postedRegistry data

Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists

This trial does not test a peptide that PepBank tracks.

  • Measures Semaglutide, does not give it. It appears in the eligibility rules.
  • Measures Tirzepatide, does not give it. It appears in the eligibility rules.
  • Names Glucagon, does not test it. It appears in the title.

Overview

Status
Completed
Phase
Phase 2
Enrollment
68 participants (actual)
Sponsor
Response Pharmaceuticals · Industry
Design
Randomized · Triple masking
Countries
1 country

United States

Start
27 Sept 2024
Primary completion
4 Jan 2025
Completion
13 May 2025
First posted
15 Oct 2024
Last update posted
2 Jul 2026
Conditions
Triglycerides · Weight Gain Trajectory · Cholesterol, Elevated

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202420252026
  1. Ph 2

    Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists

    NCT06640972

    27 Sept 2024 to 13 May 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • RDX-002Drug
  • PlaceboDrug

Arms2

  • Experimental

    Investigational drug

    RDX-002

  • Placebo comparator

    Placebo

    Matching placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Incremental Postprandial Triglycerides (TG)

    Time frame · 12 weeks

    Registry description

    Mean percent change in incremental TG area under the curve (AUC) from baseline to week 12. Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.

Secondary outcomes(4)
  1. Total Postprandial TG

    Time frame · 12 weeks

    Registry description

    Mean percent change in total postprandial TG AUC from baseline to week 12.Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.

  2. Body Weight

    Time frame · 12 weeks

    Registry description

    Mean percent change in body weight from baseline to week 12. Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.

  3. 5% Increase in Body Weight

    Time frame · 12 weeks

    Registry description

    Percentage of patients exhibiting at least a 5% increase from baseline to Week 12.

  4. LDL-C

    Time frame · 12 weeks

    Registry description

    Mean percent change from baseline to week 12. Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 12 weeks

Incremental Postprandial Triglycerides (TG)

GroupValue (percent change)Spread
Investigational Drug-51.9172.293
Placebo43.8192.373
Secondary and other outcome results(4)
Secondary outcomeMean· 12 weeks

Total Postprandial TG

GroupValue (Percent change)Spread
Investigational Drug-1.5430.212
Placebo12.1429.931
Secondary outcomeMean· 12 weeks

Body Weight

GroupValue (Percent change)Spread
Investigational Drug5.7104.703
Placebo8.3645.864
Secondary outcomeCount of participants· 12 weeks

5% Increase in Body Weight

GroupValue (Participants)
Investigational Drug19
Placebo24
Secondary outcomeMean· 12 weeks

LDL-C

GroupValue (Percent change)Spread
Investigational Drug3.1321.619
Placebo6.5022.379

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Investigational DrugGut-specific microsomal triglyceride transfer protein (MTP) inhibitor0 / 340 / 3428 / 34
PlaceboMatching placebo0 / 341 / 3420 / 34

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 65 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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.

PepBank is a research reference. Talk to a doctor before you use any peptide.