TriglyceridesPhase 2NCT06640972
Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists
A Phase 2 study testing RDX-002 in people with Triglycerides and Weight Gain Trajectory, run by Response Pharmaceuticals at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Triglycerides, Weight Gain Trajectory, Cholesterol, Elevated
- What is being tested?
- RDX-002
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2024to 13 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent prior to the conduct of any study specific procedures;
- 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);
- Lost ≥10% or 10 kg of original (pre-GLP-1 baseline) body weight with semaglutide or tirzepatide;
- Males and females aged 18 to 65 years (both inclusive) at Screening (Visit S1);
- A hemoglobin A1C (HbA1c) of <6.5% at Screening (Visit S1);
- 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;
- 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
Who cannot join
- Type 1 or Type 2 diabetes;
- 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;
- 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;
- Total fasting (minimum of 10 hours) TGs ≥400 milligrams per deciliter (mg/dL) (4.5 millimoles per liter (mmol/L)) at Screening (Visit S1);
- Fasting glucose >126 mg/dL at Screening (Visit S1);
- 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
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- 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).
- 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;
- Known history of hematologic or coagulation disorders or a hemoglobin level <10.0 grams/deciliter (g/dL) at Screening (Visit S1);
- 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;
- 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;
- 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;
- 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;
- 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);
- 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);
- Use of any prohibited diabetes or other weight loss drugs prior to or during the study (as specified) unless meeting specific rescue criteria:
- Recent (within 30 days unless otherwise specified) initiation or discontinuation of lipid-lowering medications. Consistent background use is allowed;
- An employee or contractor of the facility conducting the study, or a family member of the principal investigator, co-investigator, or any Sponsor personnel;
- Pregnant, breastfeeding, or intending to become pregnant within 30 days after study completion or last dose of study drug;
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read more
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
Read the detailed description
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study that will be conducted at a single study site in the United States (US).
Patients who have planned discontinuation of semaglutide or tirzepatide treatment for obesity, have lost ≥10% or 10 killigrams (kg) of their original body weight and are aged 18 to 65 years will be eligible for Screening. The study will assess the efficacy of 12 weeks of treatment with 200 mg twice daily (BID) RDX-002 or placebo on the mean percentage change from baseline on postprandial triglycerides (TGs) among patients who have recently discontinued treatment with semaglutide or tirzepatide for obesity. The trial will also examine the impact of RDX-002 on body weight and fasting levels of cholesterol.
- Conditions
- Triglycerides, Weight Gain Trajectory, Cholesterol, Elevated
- Being tested
- RDX-002, Placebo
- Keywords
- RDX-002, glucagon-like peptide-1 (GLP1), triglyceride, obesity, semaglutide, tirzepatide, microsomal triglyceride transfer protein inhibitor, MTP
- Medical subject headings
- Body-Weight Trajectory, Hypercholesterolemia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RDX-002Drug
Gut-specific microsomal triglyceride transfer protein (MTP) inhibitor
PlaceboDrug
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Investigational drug | Experimental | RDX-002 Receives: Drug: RDX-002 |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental Postprandial Triglycerides (TG)
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.
Measured: 12 weeks
Secondary outcomes (4)
Total Postprandial TG
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.
Measured: 12 weeks
Body Weight
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.
Measured: 12 weeks
5% Increase in Body Weight
Percentage of patients exhibiting at least a 5% increase from baseline to Week 12.
Measured: 12 weeks
LDL-C
Mean percent change from baseline to week 12. Samples were collected at 0, 1, 2, 3, 4, 6, and 8-hours hours post dose.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start27 Sep 2024
- Primary completion4 Jan 2025
- Study completion13 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for TriglyceridesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Response Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Trisha Stamp, PhD, PA-C, Principal investigator, Nucleus Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06640972
- Sponsor's protocol ID
- RDX-002-024-011
- Status last verified
- May 2026
- First submitted
- 8 Oct 2024
- Last updated
- 2 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06640972
- Acronym / sponsor ID
- RDX-002-024-011
- Conditions
- Triglycerides, Weight Gain Trajectory, Cholesterol, Elevated
- Keywords
- RDX-002, glucagon-like peptide-1 (GLP1), triglyceride, obesity, semaglutide, tirzepatide, microsomal triglyceride transfer protein inhibitor, MTP
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Response PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 4 Jan 2025 (actual)
- Study completion
- 13 May 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Posted 2 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study that will be conducted at a single study site in the United States (US).
Patients who have planned discontinuation of semaglutide or tirzepatide treatment for obesity, have lost ≥10% or 10 killigrams (kg) of their original body weight and are aged 18 to 65 years will be eligible for Screening. The study will assess the efficacy of 12 weeks of treatment with 200 mg twice daily (BID) RDX-002 or placebo on the mean percentage change from baseline on postprandial triglycerides (TGs) among patients who have recently discontinued treatment with semaglutide or tirzepatide for obesity. The trial will also examine the impact of RDX-002 on body weight and fasting levels of cholesterol.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational drug | Experimental | Drug: RDX-002RDX-002 |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Willing and able to provide written informed consent prior to the conduct of any study specific procedures;
- 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);
- Lost ≥10% or 10 kg of original (pre-GLP-1 baseline) body weight with semaglutide or tirzepatide;
- Males and females aged 18 to 65 years (both inclusive) at Screening (Visit S1);
- A hemoglobin A1C (HbA1c) of <6.5% at Screening (Visit S1);
Key exclusion criteria (20 listed)
- Type 1 or Type 2 diabetes;
- 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;
- 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;
- Total fasting (minimum of 10 hours) TGs ≥400 milligrams per deciliter (mg/dL) (4.5 millimoles per liter (mmol/L)) at Screening (Visit S1);
- Fasting glucose >126 mg/dL at Screening (Visit S1);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RDX-002Gut-specific microsomal triglyceride transfer protein (MTP) inhibitor | Drug | Investigational drug |
| PlaceboMatching placebo | Drug | Placebo |
Primary outcome
Incremental Postprandial Triglycerides (TG)
Time frame: 12 weeks
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.
4 secondary outcomes
Total Postprandial TG
Time frame: 12 weeks
Body Weight
Time frame: 12 weeks
5% Increase in Body Weight
Time frame: 12 weeks
LDL-C
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Metabolic and Inflammatory Indices in Lateral Epicondylitis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Trisha Stamp, PhD, PA-C principal investigator
Nucleus Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RDX-002 in people with Triglycerides and Weight Gain Trajectory, run by Response Pharmaceuticals at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incremental Postprandial Triglycerides (TG) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.