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

Purpose

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.

Condition

  • Obesity & Overweight

Eligibility

Eligible Ages
Between 18 Years and 65 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Body Mass Index 30 to 45

Exclusion Criteria

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Clinical Research Institute of Minnesota
Minneapolis, Minnesota 55402
Contact:
Gary D Berman, M.D.
612-333-2200
gdb@allergy-asthma-docs.com

More Details

Status
Recruiting
Sponsor
Gila Therapeutics, Inc.

Study Contact

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.