Topical-Lingual Semaglutide for Obesity in Adults
Official title: 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
Run by Gila Therapeutics, Inc. · NCT07728383 · Data updated 2026-11-12
This study tests a topical-lingual liquid form of semaglutide to help adults with obesity see if it can promote weight loss compared with the standard tablet and placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Gila Therapeutics, Inc. Industry-sponsored |
| Locations | 1 site (Minneapolis, Minnesota) |
| Status | Recruiting |
| Started | June 17, 2026 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | July 27, 2026 |
| Trial ID | NCT07728383 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with BMI 30-45 who do not have type 2 diabetes and do not have MEN2 or medullary thyroid cancer.
✕Probably not a fit
Individuals with type 2 diabetes or those with excluded thyroid or neoplastic conditions may not experience benefit and could be ineligible for this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a phase 4, interventional study evaluating a topical-lingual liquid emulsion of semaglutide against the tablet form and a placebo in adults with obesity or overweight. Participants will be randomized to receive the topical-lingual semaglutide, the Wegovy tablet, or placebo, with the goal of comparing weight loss, safety, and tolerability across groups. Pharmacokinetic data, including maximum serum concentration, will be collected to understand exposure for the different delivery methods. The study aims to establish proof-of-concept for topical-lingual delivery of metabolic hormones and its potential to impact weight management. Enrollment is limited to adults with BMI 30-45 without type 2 diabetes or certain thyroid/neoplasm conditions.
Why it matters
Potential benefit: If successful, participants could experience meaningful weight loss with a potentially convenient topical-lingual option.
How similar studies have gone: This is a proof-of-concept for a novel topical-lingual delivery approach; prior systemic GLP-1RA trials showed weight loss with oral forms, but this exact delivery method is novel in this context.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Body Mass Index 30 to 45 Exclusion Criteria: * Type 2 Diabetes Mellitus * Multiple Endocrine Neoplasia Type 2 * Medullary thyroid cancer
Where it's running
-
Clinical Research Institute of Minnesota
Minneapolis, Minnesota, United States Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.