Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640972
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Effects of RDX-002 on Postprandial Triglycerides in Patients Discontinuing GLP-1 Agonists
Sponsor:
None
Organization:
None
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None