Additive Benefits of Semaglutide for open-AngLe glaucoma – an Opportunity for Neuroprotection (ABSALON)

2024-518510-87-00 Therapeutic use (Phase IV) Ongoing, recruiting

Start 10 Apr 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)
Status Ongoing, recruiting
Participants planned 126
Countries 1
Sites 1

Glaucoma

The aim of this clinical trial is to investigate whether oral semaglutide can safely improve inner retinal function in patients with glaucoma.

Key facts

Sponsor
Rigshospitalet
Participant type
Patients
Age range
18-64 years, 65+ years
Gender
Male and Female
Therapeutic area
Diseases [C] - Eye Diseases [C11]
Trial duration
10 Apr 2025 → ongoing
Decision date (initial)
2024-11-15
Transition trial
Yes
Low-intervention
No
Rare-disease indication
No
Vulnerable population
No
Funding sources
Novo Nordisk Foundation

External identifiers

EU CT number
2024-518510-87-00
EudraCT number
2022-004142-35

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

The aim of this clinical trial is to investigate whether oral semaglutide can safely improve inner retinal function in patients with glaucoma.

Conditions and MedDRA coding

Glaucoma

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

  1. Ability to read and speak Danish
  2. 45 years or older at the time of inclusion
  3. Visual acuity equal to or above 0.5 in the study eye
  4. Diagnosis of primary open-angle glaucoma with mean deviation (MD) ≤ 16 dB with repeatable and reliable (false positive less than 15 %) visual field loss measured by standard automated perimetry on at least one eye
  5. Receiving intraocular pressure (IOP) lowering glaucoma treatment
  6. Nerve fiber layer defects identified by optical coherence tomography (OCT)

Exclusion criteria 12

  1. Diabetes or renal impairment
  2. Medical history of significant eye disease (including ocular trauma) other than glaucoma
  3. Ocular inflammation/infection within three months from inclusion
  4. Intraocular surgery 3 months before inclusion
  5. Smoker at the time of inclusion
  6. Pregnant or breast-feeding
  7. Females of childbearing potential who are not using adequate contraceptive
  8. Subjects allergic to drug ingredients administered during the trial
  9. Subjects with untreated severe systemic disease or malignancies
  10. Previous history of pancreatitis
  11. BMI < 18.5
  12. Subjects receiving treatment with: Dipeptidyl peptidase–4 inhibitors, Other GLP-1RAs, Insulin, Insulin analogues, Sulfonylurea, Systemic corticosteroids, or Immunosuppressants

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

  1. Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram between baseline and month 6.

Secondary endpoints 4

  1. Change in the inner retinal function assessed by mean change in the photopic negative response of the electroretinogram between baseline and month 3.
  2. Functional glaucoma progression assessed using the Pelli-Robson chart contrast sensitivity test.
  3. Health-related quality of life (HRQoL) assessed using two standardized validated questionnaires administered in Danish; the European Quality of life – 5 Dimensions – 3 Levels (EQ-5D-3L) questionnaire and the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25).
  4. Safety and tolerance of oral semaglutide treatment in patients with glaucoma assessed by incidence of treatment emergent adverse events (TEAEs) and changes in safety-related blood analysis.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 3

Rybelsus 3 mg tablets

PRD7996058 · Product

Active substance
Semaglutide
Substance synonyms
NNC0113-0217
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
3 mg milligram(s)
Max total dose
93 mg milligram(s)
Max treatment duration
1 Month(s)
Authorisation status
Authorised
ATC code
A10BJ06 — -
Marketing authorisation
EU/1/20/1430/004
MA holder
NOVO NORDISK A/S
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
The drug product to be used in the clinical trial is a clinical version of the marketed product. For the clinical version the tablets will be without debossment on one face, and have “M8” debossed on the other. All tablet strengths and the placebo product will have the same debossment to allow for blinding. Additionally, the packaging and labelling are different to the marketed products, to allow for blinding.

Rybelsus 7 mg tablets

PRD8500381 · Product

Active substance
Semaglutide
Substance synonyms
NNC0113-0217
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
7 mg milligram(s)
Max total dose
217 mg milligram(s)
Max treatment duration
1 Month(s)
Authorisation status
Authorised
ATC code
A10BJ06 — -
Marketing authorisation
EU/1/20/1430/012
MA holder
NOVO NORDISK A/S
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
The drug product to be used in the clinical trial is a clinical version of the marketed product. For the clinical version the tablets will be without debossment on one face, and have “M8” debossed on the other. All tablet strengths and the placebo product will have the same debossment to allow for blinding. Additionally, the packaging and labelling are different to the marketed products, to allow for blinding.

Rybelsus 14 mg tablets

PRD7996063 · Product

Active substance
Semaglutide
Substance synonyms
NNC0113-0217
Pharmaceutical form
TABLET
Route of administration
ORAL
Max daily dose
14 mg milligram(s)
Max total dose
1708 mg milligram(s)
Max treatment duration
4 Month(s)
Authorisation status
Authorised
ATC code
A10BJ06 — -
Marketing authorisation
EU/1/20/1430/009
MA holder
NOVO NORDISK A/S
MA country
EU
Paediatric formulation
No
Orphan designation
No
Modified vs. Marketing Authorisation
Yes
Modification description
The drug product to be used in the clinical trial is a clinical version of the marketed product. For the clinical version the tablets will be without debossment on one face, and have “M8” debossed on the other. All tablet strengths and the placebo product will have the same debossment to allow for blinding. Additionally, the packaging and labelling are different to the marketed products, to allow for blinding.

Placebo 1

The tablets will be identical. The clinic variants of oral semaglutide 3 mg, 7 mg, 14 mg and placebo are produced with the tablet debossment ‘M8’ in 7 tablet blister packs with no colour on forming foil and no print on lid foil. The marketed Rybelsus® tablets are produced with the tablet debossment ‘3’, ‘7’ or ‘14’ on one side and ‘NOVO’ on the other side in 10 tablet blisters with coloured forming foil and print on lid foil. The differences have no impact on the stability of the product. The treatment/placebo tablets are dispensed by unblinded staff to ensure blinding of the investigator. Labeling will be in accordance with EU CTR Annex VI, local regulations, and study requirements.

N/A · Product

Other product name
N/A
Pharmaceutical form
N/A
ATC code
N/A — N/A
Marketing authorisation
N/A
MA holder
N/A
MA country
Iceland
Paediatric formulation
No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

94 Total trials 54 Recruiting 24 Ended
Academic / Non-commercial
Sponsor organisation
Rigshospitalet
Address
Valdemar Hansens Vej 1-23
City
Glostrup
Postcode
2600
Country
Denmark

Scientific contact point

Organisation
Rigshospitalet
Contact name
Miriam Kolko

Public contact point

Organisation
Rigshospitalet
Contact name
Miriam Kolko

Third parties 1

OrganisationCity, countryDuties
GCP-enheden ved Københavns Universitetshospital
ORL-000002325
 Frederiksberg, Denmark On site monitoring

Locations

1 EU/EEA country · 1 investigational sites

By country

CountryMS statusPlanned subjectsSites
Denmark Ongoing, recruiting 126 1
Rest of world — 0 —

Investigational sites

Denmark

1 site · Ongoing, recruiting
Rigshospitalet
Department of Ophthalmology, Valdemar Hansens Vej 1-23, 2600, Glostrup

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country Trial startTrial end Recruitment startRecruitment end Early termination
Denmark 2025-04-10 2025-04-10

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

TypeTitleVersion
Protocol (for publication) Protocol_2022-004142-35 5
Protocol (for publication) RFI_ABSALON_protocol 5 1
Recruitment arrangements (for publication) RFI_ABSALON_Placeholder 1
Subject information and informed consent form (for publication) L1_ICF adults_2022-004142-35 1
Subject information and informed consent form (for publication) L2_Participant information_2022-004142-35 1
Summary of Product Characteristics (SmPC) (for publication) E2_SmPC Rybelsus 1
Synopsis of the protocol (for publication) D1_Protocol synopsis DK 2022-004142-35 1

Application history

1 submissions — initial application plus substantial / non-substantial modifications

#TypeCodeSubmittedReference MSConclusionDecision date
1 INITIAL IN 2024-10-31 Denmark Acceptable
2024-11-14
 2024-11-15

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