Recruiting
Early Phase 1

GLP-1 RAs

Sponsor:

Advanced Reconstructive Surgery Alliance

Code:

NCT07012642

Conditions

Lymphedema

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

GLP-1 Receptor Agonists

Study Details

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 effectiveness of GLP-1 RAs in improving quality of life and clinical outcomes in lymphedema patients, thereby addressing a critical gap in literature and potentially offering a new treatment option.

Conditions

Lymphedema

Study ID

NCT07012642

Start date

Apr 9, 2025

Status verified date

Jun, 2025

Completion date

Apr 9, 2027

Anticipated

Primary completion date

Apr 9, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

110 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study arm

Participants will received GLP-1 RAs for 6 months to study the effects on lymphedema.

Interventions

GLP-1 Receptor Agonists

GLP-1 RAs in lymphedema

Primary outcome measure

  • Patient reported quality of life outcome using LLIS [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Giana Truax

866-266-2577gtruax@sycamoremm.com

Saba Tasawar

732-741-0970stasawar@sycamoremm.com

Locations

River Center

Recruiting

Red Bank, New Jersey, United States, 07701

Contacts

Giana Truax

8662662577gtruax@sycamoremm.com

Saba Tasawar

7327410970stasawar@sycamoremm.com

260 Old Hook Rd Suite 304

Recruiting

Westwood, New Jersey, United States, 07675

Contacts

Ivette Chacon

848-272-2772ichacon@sycamoremm.com

Principal Investigator:

Joseph Dayan, MD

More Information

Sponsor

Advanced Reconstructive Surgery Alliance

Last update posted

Jun 10, 2025

Last verified

Jun, 2025

Keywords

  • Efficacy of GLP-1 in lymphedema

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Advanced Reconstructive Surgery Alliance on 2025-06-10.