Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 to 65

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

PhasePhase 4
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment40 (estimated)
SponsorGila Therapeutics, Inc.
Industry-sponsored
Locations1 site (Minneapolis, Minnesota)
StatusRecruiting
StartedJune 17, 2026
Main results expectedMay 2027
Study endsMay 2027
Registry record updatedJuly 27, 2026
Trial IDNCT07728383 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

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.