Obesity & OverweightPhase 4NCT07728383
A Proof-of-Concept Study to Evaluate Topical-Lingual Semaglutide in Adults With Obesity
A Phase 4 study testing Semaglutide 6 mg liquid emulsion formulation and Wegovy® (semaglutide) Tablet in people with Obesity & Overweight, run by Gila Therapeutics, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Semaglutide 6 mg liquid emulsion formulation and Wegovy® (semaglutide) Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jun 2026to May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Body Mass Index 30 to 45
Who cannot join
- Type 2 Diabetes Mellitus
- Multiple Endocrine Neoplasia Type 2
- Medullary thyroid cancer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Clinical Research Institute of Minnesota
Minneapolis, Minnesota, 55402
Gary D Berman, M.D., 612-333-2200, gdb@allergy-asthma-docs.com
Kristin Weber, FNP-C, 612-333-2200, KW@allergy-asthma-docs.com
About this study
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
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.
Read the 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.
- Conditions
- Obesity & Overweight
- Being tested
- Semaglutide 6 mg liquid emulsion formulation, Wegovy® (semaglutide) Tablet, Placebo liquid emulsion formulation
- Keywords
- Obesity
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semaglutide 6 mg liquid emulsion formulationDrug
Semaglutide 6 mg liquid emulsion formulation daily
Wegovy® (semaglutide) TabletDrug
Also called Wegovy® (semaglutide) Tablet 25 mg
Wegovy® (semaglutide) Tablet 25 mg daily
Placebo liquid emulsion formulationDrug
Placebo liquid emulsion formulation daily
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide liquid emulsion formulation | Experimental | Semaglutide 6 mg liquid emulsion formulation daily Receives: Drug: Semaglutide 6 mg liquid emulsion formulation |
| Placebo liquid emulsion formulation | Placebo comparator | Placebo liquid emulsion formulation daily Receives: Drug: Placebo liquid emulsion formulation |
| Wegovy Tablet | Active comparator | Wegovy (semaglutide) 25 mg Tablet daily after 90 day titration Receives: Drug: Wegovy® (semaglutide) Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent body weight change from baseline
Percentage change in body weight at 24 weeks from baseline by calibrated scale.
Measured: 24 weeks
Secondary outcomes (4)
Change in hemoglobin A1c
Percentage and absolute change in hemoglobin A1c from baseline to 24 weeks.
Measured: 24 weeks
Comparison of plasma semaglutide levels (Cmax) in 3 arms of study
Maximum Plasma Concentration (Cmax) of semaglutide measured with verified analytic method across the 3 arms of the study
Measured: 16 weeks
Proportion of subjects with 5% and 10% body weight loss
Proportion of subjects with 5% and 10% body weight loss at 24 weeks versus baseline on a calibrated scale
Measured: 24 weeks
Nausea Severity Scale
NSS measures chronic nausea severity and ranges from 0 - 4 (mean of all 4 items). Higher scores mean a worse outcome.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start17 Jun 2026
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gila Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Vasicek, Ph.D., Study chair, Gila Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728383
- Sponsor's protocol ID
- GT-G-C-102
- Status last verified
- Jul 2026
- First submitted
- 17 Apr 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07728383
- Acronym / sponsor ID
- GT-G-C-102
- Conditions
- Obesity & Overweight
- Keywords
- Obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Gila Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Jun 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Semaglutide liquid emulsion formulation | Experimental | Drug: Semaglutide 6 mg liquid emulsion formulationSemaglutide 6 mg liquid emulsion formulation daily |
| Placebo liquid emulsion formulation | Placebo comparator | Drug: Placebo liquid emulsion formulationPlacebo liquid emulsion formulation daily |
| Wegovy Tablet | Active comparator | Drug: Wegovy® (semaglutide) TabletWegovy (semaglutide) 25 mg Tablet daily after 90 day titration |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Body Mass Index 30 to 45
Key exclusion criteria (3 listed)
- Type 2 Diabetes Mellitus
- Multiple Endocrine Neoplasia Type 2
- Medullary thyroid cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semaglutide 6 mg liquid emulsion formulationSemaglutide 6 mg liquid emulsion formulation daily | Drug | Semaglutide liquid emulsion formulation |
| Wegovy® (semaglutide) TabletAlso: Wegovy® (semaglutide) Tablet 25 mgWegovy® (semaglutide) Tablet 25 mg daily | Drug | Wegovy Tablet |
| Placebo liquid emulsion formulationPlacebo liquid emulsion formulation daily | Drug | Placebo liquid emulsion formulation |
Primary outcome
Percent body weight change from baseline
Time frame: 24 weeks
Percentage change in body weight at 24 weeks from baseline by calibrated scale.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Research Institute of Minnesota
Minneapolis, United States
Thomas Vasicek, Ph.D. study chair
Gila Therapeutics, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Semaglutide 6 mg liquid emulsion formulation and Wegovy® (semaglutide) Tablet in people with Obesity & Overweight, run by Gila Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent body weight change from baseline (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026; AzTrials last refreshed its copy on 6 Nov 2026.