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NCT07728383PHASE4Recruiting

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

Gila Therapeutics, Inc.

Start Date

6/17/2026

Completion Date

5/1/2027

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.

Detailed Description

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. This study will compare the efficacy (weight loss), safety and tolerability of oral versus topical-lingual semaglutide versus placebo. Pharmacokinetic data (semaglutide Cmax) will be compared across the 3 arms.

Eligibility Criteria

Age Range: 18 years to 65 years

Inclusion Criteria: * Body Mass Index 30 to 45 Exclusion Criteria: * Type 2 Diabetes Mellitus * Multiple Endocrine Neoplasia Type 2 * Medullary thyroid cancer

Interventions

DRUG

Semaglutide 6 mg liquid emulsion formulation

DRUG

Wegovy® (semaglutide) Tablet

DRUG

Placebo liquid emulsion formulation

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Conditions

Obesity & Overweight

Locations

Clinical Research Institute of Minnesota

Minneapolis, Minnesota 55402

United States