UnknownPhase 3

Exploratory Study on the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment

An Exploratory Study Assessing the Efficacy and Safety of Semaglutide for Idiopathic Intracranial Hypertension Treatment

Lead sponsor

Capital Medical University

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Estimated enrollment

Study population

Pseudotumor Cerebri

Eligibility highlights

Primary endpoints

•Intracranial pressure•Treatment-emergent AEs (any)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06361823

Org study IDIIH-Semaglutide

Timeline

Milestones

Study first posted2024-04-12actual

Last update posted2024-04-12actual

Study start2024-05-01estimated

Primary completion2024-12-01estimated

Study completion2025-01-01estimated

Assets

Investigational agents

Semaglutide

Who this study enrolls

Pseudotumor Cerebri

Who can enroll

Minimum age18 Years

Maximum age75 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Age range from 18 to 75 years old, both male and female.

•Confirmed definite IIH with papilledema and lumbar opening pressure ≥25 cm cerebrospinal fluid according to Friedmann diagnostic criteria.

•Voluntarily sign a written informed consent form.

Exclusion criteria

•Pregnant or breastfeeding women.

•Currently using any hypoglycemic drugs, including glucagon like peptide-1 receptor agonists.

•Known to be allergic to the active ingredients or any excipients in Semaglutide.

•History or family history of Medullary Thyroid Carcinoma (MTC) or Multiple Endocrine Neoplasias (MEN1/MEN2).

•Diabetes, ketoacidosis, severe gastrointestinal diseases, pancreatitis, severe heart failure.

•Vision loss caused by other diseases, such as diabetes retinopathy, iritis, cataract, etc.

•Malignant IIH with vision at risk necessitating surgical intervention.

•Unable to cooperate in completing imaging examinations.

•History of bariatric surgery or cerebrospinal fluid diversion.

•Have used any drugs known to increase intracranial pressure within the past 3 months (including vitamin A, tetracycline drugs, lithium, etc).

•Have participated in other clinical trials within the past 3 months, or did not withdraw from other clinical trials at the time of signing the informed consent form.

•Other situations determined by the researcher that may pose a threat to the patients' life safety or may have an impact on the study.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other clinical outcomes

Weight & body composition

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Body mass index

Time frame:Baseline + 12 weeks

BMI, change

change from baseline, improvement

Patient-reported / QoL

1 endpoint

Secondary/protocol endpoint

Headache severity

Time frame:Baseline + 12 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

Adverse reactions

Time frame:12 weeks

Treatment-emergent AEs (any)

event count, event

Other clinical outcomes

4 endpoints

Primary/protocol endpoint

Intracranial pressure

Time frame:12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Degree of papilledema

Time frame:Baseline + 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Perimetric mean deviation

Time frame:Baseline + 12 weeks

change from baseline, improvement

Secondary/protocol endpoint

Optic nerve sheath diameter

Time frame:Baseline + 12 weeks

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.