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Clinical Trial NCT07012642 for Lymphedema is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Efficacy of GLP-1 Receptor Agonists in Treating Upper and Lower Extremity Lymphedema Early Phase 1 110
Clinical Trial NCT07012642 is designed to study Treatment for Lymphedema. It is a Early Phase 1 interventional study that is recruiting, having started on April 9, 2025, with plans to enroll 110 participants. Led by Advanced Reconstructive Surgery Alliance, it is expected to complete by April 9, 2027. The latest data from ClinicalTrials.gov was last updated on June 10, 2025.
Brief Summary
Lymphedema affects millions and currently lacks effective drug treatments, relying mainly on compression therapy. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) have shown potential in managing obesity and diabetes, which can worsen lymphedema. Although anecdotal evidence suggests benefits of GLP-1 RAs for lymphedema patients, rigorous prospective studies are lacking. This study aims to evaluate the effectiven...Show More
Detailed Description
Research Protocol: GLP-1Ras - Investigator-Initiated Study
Principal Investigator: Joseph Dayan, MD, MBA
Title: Efficacy of GLP-1 Receptor Agonists in Treating Upper and Lower Extremity Lymphedema
Background and Rationale
Introduction: Lymphedema is an incurable and relentless progressive disease marked by swelling of the upper or lower limb requiring life-long compression. Patients have a high risk of cellulitis...
Show MoreOfficial Title
Efficacy of GLP-1 Receptor Agonists in Treating Upper and Lower Extremity Lymphedema
Conditions
LymphedemaOther Study IDs
- GLP-1 in Lymphedema
NCT ID Number
Start Date (Actual)
2025-04-09
Last Update Posted
2025-06-10
Completion Date (Estimated)
2027-04-09
Enrollment (Estimated)
110
Study Type
Interventional
PHASE
Early Phase 1
Status
Recruiting
Keywords
Efficacy of GLP-1 in lymphedema
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalStudy arm Participants will received GLP-1 RAs for 6 months to study the effects on lymphedema. | GLP-1 Receptor Agonists GLP-1 RAs in lymphedema |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Patient reported quality of life outcome using LLIS | Lymphedema Life Impact Scale | 6 months |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Physiological improvement | Limb volume Bioimpedance BMI Incidence of cellulitis Compression use | 6 months |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Adults 18 years or older with unilateral upper or lower extremity lymphedema Limb volume > 5% BMI => 23 Oncology clearance if there is a cancer history
Moderate to severe venous insufficiency Actively using GLP-1 RAs Known intolerance or adverse effect to GLP-1 RAs Medical history or morbidity where GLP-1 RAs are contraindicated as per patient's primary care provider such as MEN syndrome or history of thyroid cancer.
Advanced Reconstructive Surgery AllianceStudy Responsible Party
Joseph Dayan, Principal Investigator, Principal Investigator, Advanced Reconstructive Surgery Alliance
Study Central Contact
Contact: Giana Truax, 866-266-2577, [email protected]
Contact: Saba Tasawar, 732-741-0970, [email protected]
2 Study Locations in 1 Countries
New Jersey
River Center, Red Bank, New Jersey, 07701, United States
Giana Truax, Contact, 8662662577, [email protected]
Saba Tasawar, Contact, 7327410970, [email protected]
Recruiting
260 Old Hook Rd Suite 304, Westwood, New Jersey, 07675, United States
Ivette Chacon, Contact, 848-272-2772, [email protected]
Joseph Dayan, MD, Principal Investigator
Recruiting