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A Study Investigating Oral Semaglutide in People with Open-Angle Glaucoma

Plain-language guide to NCT06792422: phase 4 randomized trial of Semaglutide, 126 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT06792422
Phase
phase 4
Status
recruiting participants
Start
2025-01
Completion (planned or actual)
2028-08
Participants
126 (estimated)
Design
randomized, quadruple-blind, treatment
Conditions studied
Primary Open Angle Glaucoma (POAG); Open-Angle Glaucoma; Glaucoma
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested Semaglutide.

The aim of this clinical trial is to investigate whether oral semaglutide can be used to treat open-angle glaucoma.

Researchers will compare oral semaglutide to a placebo (a look-alike substance that contains no drug).

It had two arms (groups): Oral Semaglutide (experimental) and Placebo (placebo comparator).

Participants are given oral semaglutide once daily.

Participants are given oral placebo once daily.

The registry classes the interventions as drug.

Who Took Part

126 planned participants were the target.

It was open to people of any sex aged from 45 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Ability to read and speak Danish. 45 years or older at the time of inclusion. Visual acuity equal to or above 0.5 in the study eye. Receiving IOP-lowering glaucoma treatment. Nerve fiber layer defects identified by OCT.

The full record lists 6 inclusion and 12 exclusion criteria; among the exclusions: diabetes or renal impairment; ocular inflammation/infection within three months from inclusion; intraocular surgery 3 months before inclusion.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The participants were allocated by chance, so the Semaglutide group and the comparison group should start out alike.

The Semaglutide group and the comparison group ran side by side rather than switching.

Neither the participants nor the staff measuring them knew who was on Semaglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2025-01 with completion listed for 2028-08.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Photopic negative response of the electroretinogram after 6 months (time frame: From baseline to month 6).

It also tracked 5 secondary outcomes, for example Photopic negative response of the electroretinogram after 3 months, Pelli-Robson chart contrast sensitivity test, Health-related quality of life (HRQoL), Health-related quality of life (HRQoL) and Number of treatment-related adverse events as assessed by CTCAE v5.0.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Semaglutide in 126 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Semaglutide compound page, all human trials.

Our Notes on the Compound

Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.