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

NCT07728383 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-07-27

No results posted yet for this study

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.

Conditions

  • Obesity & Overweight

Interventions

DRUG

Semaglutide 6 mg liquid emulsion formulation

Semaglutide 6 mg liquid emulsion formulation daily

DRUG

Wegovy® (semaglutide) Tablet

Wegovy® (semaglutide) Tablet 25 mg daily

DRUG

Placebo liquid emulsion formulation

Placebo liquid emulsion formulation daily

Sponsors & Collaborators

  • Gila Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Vasicek, Ph.D. · Gila Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-17
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07728383 on ClinicalTrials.gov