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RDX-002 for Triglycerides

Phase 2

Recruiting

Led By Trisha Stamp, PhD, PA-C

Research Sponsored by Response Pharmaceuticals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planned or willing discontinuation of semaglutide or tirzepatide for the treatment of obesity prior to randomization through EOS

Lost ≥10% or 10 kg of original body weight with semaglutide or tirzepatide

Must not have

Type 1 or Type 2 diabetes

Renal dysfunction or glomerulonephritis (eGFR <60 mL/min)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Summary

"This trial will test if drug RDX-002 can lower high fat levels in adults' blood. It will also study the drug's safety. The main question is whether RDX-002 can reduce

Who is the study for?

This trial is for adults with high blood fat levels who recently stopped taking semaglutide or tirzepatide for obesity. Participants will take RDX-002 or a placebo daily for 12 weeks and visit the clinic every 4 weeks.

What is being tested?

The study tests if RDX-002 can lower triglycerides after a high-fat meal in patients no longer on GLP-1 agonists. It compares RDX-002's effects on post-meal triglycerides, body weight, and fasting cholesterol to a placebo.

What are the potential side effects?

Possible side effects of RDX-002 are not detailed here but generally could include reactions at the drug administration site, gastrointestinal symptoms, changes in appetite or metabolism, and other drug-specific effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am willing to stop taking semaglutide or tirzepatide for obesity before the study starts.

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I have lost 10% or more of my original weight with semaglutide or tirzepatide.

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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have diabetes.

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My kidney function is reduced (eGFR <60 mL/min).

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I have stomach or intestine issues that could affect how my body absorbs medication.

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I have liver disease or dysfunction, including hepatitis B or C.

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I haven't taken any experimental drugs except for GLP-1 agonists in the last 30 days.

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I have not used any prohibited diabetes or weight loss drugs.

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I do not have blood or clotting disorders and my hemoglobin is above 10.0 g/dL.

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I have not needed cancer treatment in the last 5 years.

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I haven't donated blood, had major surgery, or been in a study in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Triglycerides

Secondary study objectives

Change in body weight by 5%

Change in mean percent body weight

LDL-C

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Investigational drugExperimental Treatment1 Intervention

The effect of 12 weeks of treatment with RDX-002 on postprandial TGs, fasting levels of cholesterol, and body weight among patients who have recently discontinued treatment with the GLP-1 agonists, semaglutide or tirzepatide, for obesity.

Group II: PlaceboPlacebo Group1 Intervention

Matching placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

RDX-002

2023

Completed Phase 1

~30

0 / 12Eligibility criteria met