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
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Minneapolis, Minnesota 55402
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.