Evaluation of Topical-Lingual Semaglutide Liquid Emulsion Versus Wegovy Tablet and Placebo for Weight Loss in Adults with Obesity

What this Trial Is About

Researchers are studying the delivery of semaglutide, a GLP-1 receptor agonist, using a topical-lingual T-L oral liquid emulsion in adults with obesity. The study aims to explore this proof-of-concept method for delivering metabolic hormones and compare the effects on weight loss, safety, and tolerability against oral semaglutide tablets and placebo. The trial is a randomized, phase 4 study focused on treatment of obesity. Participants will be assigned to one of three groups daily semaglutide 6 mg liquid emulsion via topical-lingual delivery, daily placebo liquid emulsion, or daily Wegovy semaglutide 25 mg tablet after a 90-day dose escalation. The study will evaluate pharmacokinetics, including plasma semaglutide levels, and measure outcomes over 24 weeks. During the study, participants will have their body weight, hemoglobin A1c, and nausea severity assessed, along with semaglutide blood levels at 16 weeks. The main outcome is percent change in body weight from baseline at 24 weeks. Safety, tolerability, and proportion achieving weight loss of 5% and 10% will also be monitored. The trial is expected to last until May 2027 and includes adults aged 18 to 65 with obesity.

A Proof-of-Concept Study to Evaluate Topical-Lingual Semaglutide in Adults With Obesity