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

NCT ID: NCT06792422

Last Updated: 2025-01-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2028-12-31

Brief Summary

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oral Semaglutide

Participants are given oral semaglutide once daily.

Group Type: EXPERIMENTAL

Oral semaglutide

Intervention Type: DRUG

Participants will receive oral semaglutide once daily.

1. Starting dose 3 mg/day for one month (day 1-28)

2. Intermediate dose 7 mg/day for one month (day 29-56)

3. Maintenance dose 14 mg/day (day 57-182)

Placebo

Participants are given oral placebo once daily.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Participants will receive an oral placebo once daily.

1. Placebo tablets received on visit 1 (baseline) for one month (day 1-28)

2. Placebo tablets received on visit 2 (month 1) for one month (day 29-56)

3. Placebo tablets received on visit 3 (month 2) for four months (day 57-182)

Interventions

Oral semaglutide

Participants will receive oral semaglutide once daily.

1. Starting dose 3 mg/day for one month (day 1-28)

2. Intermediate dose 7 mg/day for one month (day 29-56)

3. Maintenance dose 14 mg/day (day 57-182)

Intervention Type: DRUG

Placebo

Participants will receive an oral placebo once daily.

1. Placebo tablets received on visit 1 (baseline) for one month (day 1-28)

2. Placebo tablets received on visit 2 (month 1) for one month (day 29-56)

3. Placebo tablets received on visit 3 (month 2) for four months (day 57-182)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

Miriam Kolko

Professor in Translational Eye Research, Chief Physician.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Ophthalmology, Rigshospitalet

Glostrup Municipality, , Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Miriam Kolko, MD, PhD

Role: CONTACT

miriamk@sund.ku.dk

+45 29807667

Anna-Sophie Thein

Role: CONTACT

anna-sophie.thein@sund.ku.dk

Facility Contacts

Miriam Kolko, MD, PhD, Professor, Consultant

Role: primary

miriamk@sund.ku.dk

+45 29807667

Other Identifiers

97669

Identifier Type: -

Identifier Source: org_study_id

NNF22OC0079544

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2024-518510-87-00

Identifier Type: CTIS

Identifier Source: secondary_id