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A Proof-of-Concept Study to Evaluate Topical-Lingual Semaglutide in Adults With Obesity
Sponsor: Gila Therapeutics, Inc.
Summary
This study investigates the Topical-Lingual (T-L) delivery of semaglutide, a GLP-1 receptor agonist (GLP-1RA), via an oral liquid emulsion formulation as a Proof-of-Concept for the T-L delivery of metabolic hormones in general. GLP-1 is a gut-derived hormone that induces satiation through hypothalamic pathways.
Official title: A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Topical-Lingual Semaglutide (T-L Semaglutide) in Adults With Obesity
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-06-17
Completion Date
2027-05
Last Updated
2026-07-27
Healthy Volunteers
No
Conditions
Interventions
Semaglutide 6 mg liquid emulsion formulation
Semaglutide 6 mg liquid emulsion formulation daily
Wegovy® (semaglutide) Tablet
Wegovy® (semaglutide) Tablet 25 mg daily
Placebo liquid emulsion formulation
Placebo liquid emulsion formulation daily
Locations (1)
Clinical Research Institute of Minnesota
Minneapolis, Minnesota, United States