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Glucagone Like Peptide-1 Receptor (GLP-1R) Analogue Assisted Rapid Weight Loss Program as treatment of Idiopathic Intracranial Hypertension

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-517120-19-02
Enrollment
50
Registered
2024-12-09
Start date
2022-09-02
Completion date
2025-10-28
Last updated
2025-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Intracranial Hypertension

Brief summary

Change in lumbar opening pressure after 8 weeks, Change in body weight after 8 weeks

Detailed description

Change in lumbar opening pressure after 10 months, Change in body weight after 10 months, Degree of papilledema (Frisén grade), Visual field perimetric mean deviation (MD) by automated perimetry, Optical coherence tomography (OCT) changes including enhanced depth imaging (EDI) OCT, confocal scanning laser ophthalmoscopy (cSLO) and OCT angiography (OCTA), Optic disc elevation (ODE) and optic nerve sheath diameter (ONSD) by transorbital ultrasonography, HURT score (Headache Under Response to Treatment), Number of monthly headache days, Mean monthly headache intensity, Need of prophylactic and acute headache medication, Percentage in full or partial remission after 10 months (absence of papilledema with or without ICP < 25 cm CSF, respectively), Body fat percentage and truncal adiposity (8 weeks and 10 months DEXA scan), Quality of life (WHO QoL questionnaire short version, 8 weeks and 10 months), Drop-out before 8 weeks and 10-month follow-up, Urinary ketosis, Use of ICP regulating medication including Acetazolamide, Topiramate, diuretics (daily dose and length of treatment), Biomarkers in CSF, blood, and urine (baseline, 8 weeks and 10 months), including change in metabolic parameters (HOMA2IR, HbA1c, glucose, serum lipids, biomarkers of the adrenal system, and liver and kidney function, etc.), Adverse events and reactions, Presence of non-alcoholic fatty liver disease (NAFLD) (8 weeks and 10 months) assessed by ultrasonography, Concentratoin Semaglutide in cerebrospinal fluid

Interventions

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Change in lumbar opening pressure after 8 weeks, Change in body weight after 8 weeks

Secondary

MeasureTime frame
Change in lumbar opening pressure after 10 months, Change in body weight after 10 months, Degree of papilledema (Frisén grade), Visual field perimetric mean deviation (MD) by automated perimetry, Optical coherence tomography (OCT) changes including enhanced depth imaging (EDI) OCT, confocal scanning laser ophthalmoscopy (cSLO) and OCT angiography (OCTA), Optic disc elevation (ODE) and optic nerve sheath diameter (ONSD) by transorbital ultrasonography, HURT score (Headache Under Response to Treatment), Number of monthly headache days, Mean monthly headache intensity, Need of prophylactic and acute headache medication, Percentage in full or partial remission after 10 months (absence of papilledema with or without ICP < 25 cm CSF, respectively), Body fat percentage and truncal adiposity (8 weeks and 10 months DEXA scan), Quality of life (WHO QoL questionnaire short version, 8 weeks and 10 months), Drop-out before 8 weeks and 10-month follow-up, Urinary ketosis, Use of ICP regulating medic

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026