GLP-1 medicines for upper and lower limb lymphedema
Efficacy of GLP-1 Receptor Agonists in Treating Upper and Lower Extremity Lymphedema
This study will try GLP-1 receptor agonist medications to see if they improve symptoms and quality of life for adults with upper or lower limb lymphedema.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Advanced Reconstructive Surgery Alliance Government |
| Locations | 2 sites (Red Bank, New Jersey and 1 other locations) |
| Trial ID | NCT07012642 on ClinicalTrials.gov |
What this trial studies
This is an early-phase, investigator-initiated interventional study testing GLP-1 receptor agonists in adults with unilateral upper or lower extremity lymphedema. Eligible participants must be ≥18 years old with limb volume >5% and BMI ≥23, and those with a cancer history require oncology clearance. Key exclusions include moderate-to-severe venous insufficiency, current GLP-1 use, or contraindications such as MEN syndrome or prior thyroid cancer. Outcomes will focus on clinical measures of lymphedema and patient-reported quality of life, with study visits conducted at two New Jersey sites.
Who should consider this trial
Good fit: Adults aged 18 or older with unilateral upper or lower extremity lymphedema, limb volume >5%, BMI ≥23, and oncology clearance if applicable are the ideal candidates.
Not a fit: Patients with moderate-to-severe venous insufficiency, active use of GLP-1 medications, or medical contraindications to GLP-1 RAs (for example MEN syndrome or prior thyroid cancer) are unlikely to be eligible or benefit from this study.
Why it matters
Potential benefit: If successful, GLP-1 receptor agonists could reduce limb swelling, lower infection risk, and improve quality of life, potentially providing the first drug treatment option for lymphedema.
How similar studies have performed: There are anecdotal reports of improvement but no prospective clinical trials have yet proven that GLP-1 receptor agonists help lymphedema; GLP-1 drugs are well established for weight loss and diabetes control.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Where this trial is running
Red Bank, New Jersey and 1 other locations
- River Center — Red Bank, New Jersey, United States (Recruiting)
- 260 Old Hook Rd Suite 304 — Westwood, New Jersey, United States (Recruiting)
Study contacts
- Study coordinator: Giana Truax
- Email: gtruax@sycamoremm.com
- Phone: 866-266-2577
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.