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

Sponsor
Glostrup University Hospital, Copenhagen
Study ID
NCT06792422
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Oral semaglutide — 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 — 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)

Study Details

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).

Key Dates

Start date
Jan 31, 2025
Status verified
Nov 2024
Primary completion
Aug 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
126 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oral Semaglutide
    Participants are given oral semaglutide once daily.
  • Placebo Comparator: Placebo
    Participants are given oral placebo once daily.

Primary Outcome Measure

Photopic negative response of the electroretinogram after 6 months [ Time Frame: From baseline to month 6. ]

Central Contacts

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