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

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

Recruiting
18-65 years
All
Phase 4
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Overview

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.

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

Inclusion Criteria:

  • Body Mass Index 30 to 45

Exclusion Criteria:

  • Type 2 Diabetes Mellitus
  • Multiple Endocrine Neoplasia Type 2
  • Medullary thyroid cancer

Study details
    Obesity & Overweight

NCT07728383

Gila Therapeutics, Inc.

1 August 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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