Efficacy of GLP-1 Receptor Agonists in Treating Upper and Lower Extremity Lymphedema
1 other identifier
interventional
110
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Apr 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 9, 2025
CompletedFirst Submitted
Initial submission to the registry
June 1, 2025
CompletedFirst Posted
Study publicly available on registry
June 10, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 9, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 9, 2027
June 10, 2025
June 1, 2025
2 years
June 1, 2025
June 1, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient reported quality of life outcome using LLIS
Lymphedema Life Impact Scale
6 months
Secondary Outcomes (1)
Physiological improvement
6 months
Study Arms (1)
Study arm
EXPERIMENTALParticipants will received GLP-1 RAs for 6 months to study the effects on lymphedema.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
River Center
Red Bank, New Jersey, 07701, United States
260 Old Hook Rd Suite 304
Westwood, New Jersey, 07675, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
June 1, 2025
First Posted
June 10, 2025
Study Start
April 9, 2025
Primary Completion (Estimated)
April 9, 2027
Study Completion (Estimated)
April 9, 2027
Last Updated
June 10, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- At the conclusion of the study (start date) For five years (end date)
- Access Criteria
- All de-identified study documents will be available.
De-identified study results.