A Proof-of-Concept Study to Evaluate Topical-Lingual Semaglutide in Adults With Obesity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Semaglutide 6 mg liquid emulsion formulation, Wegovy® (semaglutide) Tablet, Placebo liquid emulsion formulation.
- Who it may be relevant to
- Registry conditions: Obesity & Overweight. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
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.
Interventions
- Drug Semaglutide 6 mg liquid emulsion formulation
Semaglutide 6 mg liquid emulsion formulation daily - Drug Wegovy® (semaglutide) Tablet
Wegovy® (semaglutide) Tablet 25 mg daily - Drug Placebo liquid emulsion formulation
Placebo liquid emulsion formulation daily
Primary outcome measures
- Percent body weight change from baseline [Time frame: 24 weeks]
Secondary outcome measures (4)
- Change in hemoglobin A1c [Time frame: 24 weeks]
- Comparison of plasma semaglutide levels (Cmax) in 3 arms of study [Time frame: 16 weeks]
- Proportion of subjects with 5% and 10% body weight loss [Time frame: 24 weeks]
- Nausea Severity Scale [Time frame: 24 weeks]
Eligibility criteria
Inclusion criteria
- Body Mass Index 30 to 45
Exclusion criteria
- Type 2 Diabetes Mellitus
- Multiple Endocrine Neoplasia Type 2
- Medullary thyroid cancer
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Clinical Research Institute of Minnesota — Minneapolis
Identifiers
NCT: NCT07728383 · GT-G-C-102