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NCT Number: NCT07728383

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

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.

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Key information

Conditions

Obesity & Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Body Mass Index 30 to 45

Exclusion criteria

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

Treatment and study plan

Semaglutide 6 mg liquid emulsion formulation

Drug

Semaglutide 6 mg liquid emulsion formulation daily

Wegovy® (semaglutide) Tablet

Drug

Wegovy® (semaglutide) Tablet 25 mg daily

Other names: Wegovy® (semaglutide) Tablet 25 mg

Placebo liquid emulsion formulation

Drug

Placebo liquid emulsion formulation daily

Primary outcomes

  1. Percent body weight change from baseline

    Time frame: 24 weeks

    Percentage change in body weight at 24 weeks from baseline by calibrated scale.

Secondary outcomes

  1. Change in hemoglobin A1c

    Time frame: 24 weeks

    Percentage and absolute change in hemoglobin A1c from baseline to 24 weeks.

  2. Comparison of plasma semaglutide levels (Cmax) in 3 arms of study

    Time frame: 16 weeks

    Maximum Plasma Concentration (Cmax) of semaglutide measured with verified analytic method across the 3 arms of the study

  3. Proportion of subjects with 5% and 10% body weight loss

    Time frame: 24 weeks

    Proportion of subjects with 5% and 10% body weight loss at 24 weeks versus baseline on a calibrated scale

  4. Nausea Severity Scale

    Time frame: 24 weeks

    NSS measures chronic nausea severity and ranges from 0 - 4 (mean of all 4 items). Higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Gila Therapeutics, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 27, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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