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

Glostrup University Hospital, Copenhagen

Status and phase: Enrolling; Phase 4

Conditions: Open-Angle Glaucoma; Primary Open Angle Glaucoma (POAG); Glaucoma

Treatments: Drug: Placebo; Drug: Oral semaglutide

Study type: Interventional

Funder types: Other

Identifiers

NCT06792422

97669

2024-518510-87-00 (EU Trial (CTIS) Number)

NNF22OC0079544 (Other Grant/Funding Number)

Details and patient eligibility

About

The aim of this clinical trial is to investigate whether oral semaglutide can be used to treat open-angle glaucoma. The main question it aims to answer is: Does oral semaglutide safely improve inner retinal function in patients with open-angle glaucoma as measured by the photopic negative response of the electroretinogram.

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

Participants will:

• Take semaglutide or a placebo every day for 6 months.
• Visit the clinic 5 times in total for tests and interviews: At baseline (the first day they are included in the study), after 1 month, after 2 months, after 3 months, and after 6 months (the last day they are included in the study).

Enrollment: 126 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Diagnosis of POAG with MD ≤ 16 dB with repeatable and reliable (false positive less than 15 %) VF loss measured by standard automated perimetry on at least one eye
• Receiving IOP-lowering glaucoma treatment
• Nerve fiber layer defects identified by OCT

Exclusion criteria

• Diabetes or renal impairment
• Medical history of significant eye disease (including ocular trauma) other than glaucoma
• Ocular inflammation/infection within three months from inclusion
• Intraocular surgery 3 months before inclusion
• Smoker at the time of inclusion
• Pregnant or breast-feeding
• Females of childbearing potential who are not using adequate contraceptive, which includes the following: Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal, progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable; Intrauterine device (IUD); Intrauterine hormone-releasing system (IUS); Bilateral tubal occlusion; Vasectomised partner; Sexual abstinence
• Subjects allergic to drug ingredients administered during the trial
• Subjects with untreated severe systemic disease or malignancies
• Previous history of pancreatitis
• BMI < 18.5
• Subjects receiving treatment with: Dipeptidyl peptidase-4 inhibitors; Other GLP-1RAs; Insulin; Insulin analogues; Sulfonylurea; Systemic corticosteroids; Immunosuppressants

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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126 participants in 2 patient groups, including a placebo group

Oral Semaglutide

Experimental group

Description:

Participants are given oral semaglutide once daily.

Treatment:

Drug: Oral semaglutide

Placebo

Placebo Comparator group

Description:

Participants are given oral placebo once daily.

Treatment:

Drug: Placebo