DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT06027567

IIH:DUAL

CompletedPhase 4

The Effect of an Anti-obesity Drug, Semaglutide, as Treatment in New-onset Idiopathic Intracranial Hypertension (IIH) Compared to Standard Weight Management (Dietician) With Regards to Change in Weight and Intracranial Pressure

Glucagon-like Peptide-1 Receptor (GLP-1R) Analogue Assisted Rapid Weight Loss Program as Treatment of Idiopathic Intracranial Hypertension

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

2

Recruiting sites

—

Enrollment

38

actual

Study population

Obesity / overweight, Pseudotumor Cerebri

Key I/E criteria

•BMI ≥27•Female

Primary endpoints

•Body weight, % change•Intracranial pressure

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06027567
Org study IDIIH:DUAL

Timeline

Milestones

Study start2022-09-02actual
Study first posted2023-09-07actual
Primary completion2025-01-28actual
Study completion2025-10-28actual
Last update posted2026-02-27actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Obesity / overweightPseudotumor Cerebri

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexFemale
Healthy volunteersNot accepted

Inclusion criteria

•Confirmed new onset definite IIH with papilledema and lumbar opening pressure ≥25 cm cerebrospinal fluid according to Friedmann diagnostic criteria
•BMI ≥ 27
•Use of contraceptive methods with failure rates of less than 1 % throughout the study period for group A and for at least an additional 2 months after cessation of Semaglutide
•Written, informed consent

Exclusion criteria

•Unable to provide written informed consent or participate
•Malignant IIH with visual threat that requires surgical intervention, i.e., cerebrospinal fluid diversion (shunting), optic nerve sheet fenestration or cerebral venous sinus stenting
•Pregnancy or breastfeeding
•Treatment with antidiabetics, blood-thinners or medication that may increase the risk of adverse events
•Diabetes, congestive heart failure, severe vascular disease, pancreatitis, severe ophthalmological disorders other than IIH (e.g. retinopathy)
•History or family history of thyroid carcinomas or Multiple Endocrine Neoplasias (MEN1/MEN2)
•History of bariatric surgery
•Known hypersensitivity to any contents of Semaglutide®
•Other severe/uncontrolled mental or physical disease

Endpoints (60)

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
32
Other (unclassified)
12
Weight & body composition
6
Safety / tolerability / PK
4
Glycemic / diabetes
2
MASH / liver
2
Patient-reported / QoL
2

Weight & body composition

6 endpoints
Primary/protocol endpoint

Weight

Time frame:8 weeks

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Weight

Time frame:10 months

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change in fat mass

Time frame:8 weeks + 10 months

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Total fat mass

Time frame:Baseline + 8 weeks + 10 months

Total fat mass

descriptive, improvement

Secondary/protocol endpoint

Truncal fat

Time frame:Baseline + 8 weeks + 10 months

Total fat mass

percent change from baseline, improvement

Secondary/protocol endpoint

Android-gynoid-ratio

Time frame:Baseline + 8 weeks and 10 months

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change in metabolic parameters

Time frame:8 weeks + 10 months

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Change in metabolic parameters

Time frame:8 weeks + 10 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

MASH / liver

2 endpoints
Secondary/protocol endpoint

Fatty liver prevalence

Time frame:Baseline + 8 weeks + 10 months

categorical status, improvement

Secondary/protocol endpoint/low confidence

Ammoniaemia_2

Time frame:Baseline + 8 weeks + 10 months

descriptive

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Quality of Life

Time frame:8 weeks + 10 months

change from baseline, improvement

Secondary/protocol endpoint

Headache burden measured by HURT questionnaire

Time frame:8 weeks + 10 months

change from baseline, improvement

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Feasibility

Time frame:8 weeks + 10 months

descriptive

Secondary/protocol endpoint

Adverse events

Time frame:8 weeks + 10 months

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Intrathecal Semaglutide

Time frame:10 months

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Ketosis

Time frame:8 weeks + 10 months

threshold achievement, event

Other clinical outcomes

32 endpoints
Primary/protocol endpoint

Intracranial pressure

Time frame:8 weeks

change from baseline, improvement

Primary/protocol endpoint

Intracranial pressure

Time frame:8 weeks

percent change from baseline, improvement

Secondary/protocol endpoint

Intracranial Pressure

Time frame:10 months

change from baseline, improvement

Secondary/protocol endpoint

Intracranial Pressure

Time frame:10 months

percent change from baseline, improvement

Secondary/protocol endpoint

Change in Papilledema

Time frame:8 weeks + 10 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Visual fields

Time frame:8 weeks + 10 months

change from baseline, improvement

Secondary/protocol endpoint

EDI-OCT

Time frame:8 weeks + 10 months

change from baseline, improvement

Secondary/protocol endpoint

Optic disc elevation

Time frame:Baseline + 8 weeks + 10 months

change from baseline, improvement

Secondary/protocol endpoint

Remission

Time frame:8 weeks + 10 months

threshold achievement, improvement

Secondary/protocol endpoint

Need of intracranial pressure-lowering medication_1

Time frame:8 weeks + 10 months

descriptive, improvement

Secondary/protocol endpoint

Monthly headache days

Time frame:Baseline + 8 weeks + 10 months

change from baseline, improvement

Secondary/protocol endpoint

Headche severity

Time frame:Baseline + 8 weeks + 10 months

descriptive, improvement

Secondary/protocol endpoint

Headache medication - Acute analgesic use

Time frame:Baseline + 8 weeks + 10 months

change from baseline, improvement

Secondary/protocol endpoint

Headache medication - preventive medication

Time frame:Baseline + 8 weeks + 10 months

categorical status, improvement

Secondary/protocol endpoint/low confidence

Optic nerve sheath diameter

Time frame:Baseline + 8 weeks + 10 months

change from baseline, improvement

Secondary/protocol endpoint

Peripapillary capillary density

Time frame:Baseline + 8 weeks + 10 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Peripapillary artery-to-venule ratio

Time frame:Baseline + 8 weeks + 10 months

ratio, descriptive

Secondary/protocol endpoint

Need of intracranial pressure-lowering medication_2

Time frame:Baseline + 8 weeks + 10 months

threshold achievement, improvement

Secondary/protocol endpoint

Lutropin

Time frame:Baseline

descriptive

Secondary/protocol endpoint

Testosteron

Time frame:Baseline

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Estradiol

Time frame:Baseline

descriptive

Secondary/protocol endpoint

Anti-Müllerian Hormone

Time frame:Baseline

descriptive

Secondary/protocol endpoint

Dehydroepiandrosterone

Time frame:Baseline

Androgen, change

descriptive

Secondary/protocol endpoint

Androstenedion

Time frame:Baseline

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Change in bone marker (CTX)

Time frame:Baseline + 8 weeks + 10 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change in bone marker (PiNP)

Time frame:baseline + 8 weeks + 10 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Regional bone density

Time frame:Baseline + 8 weeks + 10 months

change from baseline, improvement

Secondary/protocol endpoint

Androgen metabolism_1

Time frame:Baseline + 8 weeks + 10 months

Androgen, change

ratio, improvement

Secondary/protocol endpoint

Androgen metabolism_2

Time frame:Baseline + 8 weeks + 10 months

Androgen, change

ratio, improvement

Secondary/protocol endpoint

Androgen metabolism_3

Time frame:Baseline + 8 weeks + 10 months

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Androgen metabolism_4

Time frame:Baseline + 8 weeks + 10 months

Androgen, change

change from baseline, improvement

Secondary/protocol endpoint

Androgen metabolism_5

Time frame:Baseline + 8 weeks + 10 months

Androgen, change

change from baseline, improvement

Other (unclassified)

12 endpoints
Secondary/protocol endpoint/low confidence

Insulin like-Growth-Factor-1

Time frame:Baseline

descriptive

Secondary/protocol endpoint/low confidence

Insulinlike Growth Factor Binding Protein-3

Time frame:Baseline

descriptive

Secondary/protocol endpoint/low confidence

Growth hormone

Time frame:Baseline

descriptive

Secondary/protocol endpoint/low confidence

Follitropin

Time frame:Baseline

descriptive

Secondary/protocol endpoint/low confidence

Sex-Hormone Binding Globulin

Time frame:Baseline

descriptive

Secondary/protocol endpoint/low confidence

17-hydroxyprogesterone (mg/d)

Time frame:Baseline

descriptive

Secondary/protocol endpoint/low confidence

Cortisol 0 min

Time frame:Baseline

descriptive

Secondary/protocol endpoint/low confidence

Cortisol 30 min

Time frame:Baseline

concentration, descriptive

Secondary/protocol endpoint/low confidence

Pituitary adenylate cyclase-activating peptide (PACAP) Pituitary adenylate cyclase-activating peptide Pituitary adenylate cyclase-activating peptide

Time frame:Baseline + 8 weeks + 10 months

concentration, descriptive

Secondary/protocol endpoint/low confidence

Calcitonin Gene Related Peptide

Time frame:Baseline + 8 weeks + 10 months

descriptive

Secondary/protocol endpoint/low confidence

Ammoniaemia_1

Time frame:Baseline + 8 weeks + 10 months

change from baseline, descriptive

Other/protocol endpoint

Omics

Time frame:Baseline + 8 weeks + 10 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 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 1, 2026 snapshot.