Gila Therapeutics, Inc.
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 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.
Inclusion Criteria: * Body Mass Index 30 to 45 Exclusion Criteria: * Type 2 Diabetes Mellitus * Multiple Endocrine Neoplasia Type 2 * Medullary thyroid cancer
Semaglutide 6 mg liquid emulsion formulation daily
Wegovy® (semaglutide) Tablet 25 mg daily
Placebo liquid emulsion formulation daily
Arctuva estimate
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