Recruiting

Semaglutide

Sponsor:

Gila Therapeutics, Inc.

Code:

NCT07728383

Conditions

Obesity & Overweight

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Semaglutide 6 mg liquid emulsion formulation

Wegovy® (semaglutide) Tablet

Placebo liquid emulsion formulation

Study Details

Brief 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

Study ID

NCT07728383

Start date

Jun 17, 2026

Status verified date

Jul, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Body Mass Index 30 to 45

Exclusion Criteria:

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Semaglutide 6 mg liquid emulsion formulation

Semaglutide 6 mg liquid emulsion formulation daily

Wegovy® (semaglutide) Tablet

Wegovy® (semaglutide) Tablet 25 mg daily

Placebo liquid emulsion formulation

Placebo liquid emulsion formulation daily

Primary outcome measure

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

Central Contacts and Locations

Locations

Clinical Research Institute of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55402

Contacts

Gary D Berman, M.D.

612-333-2200gdb@allergy-asthma-docs.com

Kristin Weber, FNP-C

612-333-2200KW@allergy-asthma-docs.com

Principal Investigator:

Gary D Berman, M.D.

More Information

Sponsor

Gila Therapeutics, Inc.

Last update posted

Jul 27, 2026

Last verified

Jul, 2026

Keywords

  • Obesity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gila Therapeutics, Inc. on 2026-07-27.