DRUG
Semaglutide 6 mg liquid emulsion formulation
Semaglutide 6 mg liquid emulsion formulation daily
A Proof-of-Concept Study to Evaluate Topical-Lingual Semaglutide in Adults With Obesity
Status
Recruiting
Phase
Phase 4
Enrollment
40
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Full 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
Treatment arms and agents.
DRUG
Wegovy® (semaglutide) Tablet
Wegovy® (semaglutide) Tablet 25 mg daily
DRUG
Placebo liquid emulsion formulation
Placebo liquid emulsion formulation daily
Timeline
From registration to results.
First posted
Jul 27, 2026
Study start
Jun 17, 2026
Primary completion
May 2027
Study completion
May 2027
Results posted
Not reported
Registry updated
Jul 27, 2026
Outcomes
What the study measures.
Primary outcomes
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
Change in hemoglobin A1c
Time frame · 24 weeks
Percentage and absolute change in hemoglobin A1c from baseline to 24 weeks.
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
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
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.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 65 Years
- Sex
- ALL
- 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 locations
1 registered sites.
United States. Showing up to 24 locations stored in the fast local snapshot.
Clinical Research Institute of Minnesota
Minneapolis, Minnesota, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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A Study of HRS9531 Versus Semaglutide Once Weekly as Add-on Therapy to Metformin Monotherapy or in Combination With SGLT2 Inhibitors in Participants With Type 2 Diabetes
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Phase 3
Completed
884
2026-07
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Myocardial Metabolic Flux in Pulmonary Arterial Hypertension
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Not applicable
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.