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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Gila Therapeutics, Inc.
Study ID
NCT07728383
Phase
PHASE4
Status
Recruiting
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Conditions

  • Obesity & Overweight

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

First listed
Jul 27, 2026
Start date
Jun 17, 2026
Status verified
Jul 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Semaglutide liquid emulsion formulation
    Semaglutide 6 mg liquid emulsion formulation daily
  • Placebo Comparator: Placebo liquid emulsion formulation
    Placebo liquid emulsion formulation daily
  • Active Comparator: Wegovy Tablet
    Wegovy (semaglutide) 25 mg Tablet daily after 90 day titration

Primary Outcome Measure

Percent body weight change from baseline [ Time Frame: 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Clinical Research Institute of MinnesotaMinneapolisMinnesota55402
Gary D Berman, M.D.
[email protected]
612-333-2200
Kristin Weber, FNP-C
[email protected]
612-333-2200
Gary D Berman, M.D. (PRINCIPAL_INVESTIGATOR)

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By research site
Clinical Research Institute of Minnesota· Minneapolis, MN

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