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

A Proof-of-Concept, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy and Pharmacokinetics of Topical-Lingual Semaglutide (T-L Semaglutide) in Adults With Obesity

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07728383

Enrollment

Registered

2026-07-27

Start date

2026-06-17

Completion date

2027-05-01

Last updated

2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity & Overweight

Keywords

Obesity

Brief summary

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.

Interventions

DRUGSemaglutide 6 mg liquid emulsion formulation

Semaglutide 6 mg liquid emulsion formulation daily

DRUGWegovy® (semaglutide) Tablet

Wegovy® (semaglutide) Tablet 25 mg daily

DRUGPlacebo liquid emulsion formulation

Placebo liquid emulsion formulation daily

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Body Mass Index 30 to 45

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Percent body weight change from baseline	24 weeks	Percentage change in body weight at 24 weeks from baseline by calibrated scale.

Secondary

Measure	Time frame	Description
Change in hemoglobin A1c	24 weeks	Percentage and absolute change in hemoglobin A1c from baseline to 24 weeks.
Comparison of plasma semaglutide levels (Cmax) in 3 arms of study	16 weeks	Maximum Plasma Concentration (Cmax) of semaglutide measured with verified analytic method across the 3 arms of the study
Proportion of subjects with 5% and 10% body weight loss	24 weeks	Proportion of subjects with 5% and 10% body weight loss at 24 weeks versus baseline on a calibrated scale
Nausea Severity Scale	24 weeks	NSS measures chronic nausea severity and ranges from 0 - 4 (mean of all 4 items). Higher scores mean a worse outcome.

Countries

United States

Contacts

STUDY_CHAIRThomas Vasicek, Ph.D.

Gila Therapeutics, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026