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

July 21, 2026 updated by: Gila Therapeutics, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55402
        • Recruiting
        • Clinical Research Institute of Minnesota
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gary D Berman, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Body Mass Index 30 to 45

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semaglutide liquid emulsion formulation
Semaglutide 6 mg liquid emulsion formulation daily
Drug: Semaglutide 6 mg liquid emulsion formulation
Semaglutide 6 mg liquid emulsion formulation daily
Placebo Comparator: Placebo liquid emulsion formulation
Placebo liquid emulsion formulation daily
Drug: Placebo liquid emulsion formulation
Placebo liquid emulsion formulation daily
Active Comparator: Wegovy Tablet
Wegovy (semaglutide) 25 mg Tablet daily after 90 day titration
Drug: Wegovy® (semaglutide) Tablet
Wegovy® (semaglutide) Tablet 25 mg daily
Other Names:
  • Wegovy® (semaglutide) Tablet 25 mg

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gila Therapeutics, Inc.

Investigators

  • Study Chair: Thomas Vasicek, Ph.D., Gila Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

July 21, 2026

First Posted (Actual)

July 27, 2026

Study Record Updates

Last Update Posted (Actual)

July 27, 2026

Last Update Submitted That Met QC Criteria

July 21, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GT-G-C-102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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