Dual action weight loss in IIH - IIHDUAL

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Rigshospitalet

Participant type

Patients

Age range

18-64 years

Gender

Female

Therapeutic area

Diseases [C] - Hormonal diseases [C19], Diseases [C] - Eye Diseases [C11], Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Nervous System Diseases [C10]

Trial duration

2 Sep 2022 → 28 Oct 2025

Decision date (initial)

2024-12-09

Transition trial

Yes

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

No

Funding sources

Novo Nordisk Fonden

External identifiers

EU CT number

2024-517120-19-02

EudraCT number

2021-006752-14

ClinicalTrials.gov

NCT06027567

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Therapy

To investigate the effect of Semaglutide and a Very Low Calorie Diet on body weight and intracranial pressure in patients with new-onset idiopathic intracranial hypertension compared to standard management (dietician)

Secondary objectives 1

1. To evaluate the effect of semaglutide, very low-calorie diet and intervention by a dietician on quality of life, headache burden, ophthalmic outcomes, metabolic and hormonal status, fat mass, non-alcoholic fatty liver disease, and cerebrospinal fluid content of semaglutide in patients with new-onset idiopathic intracranial hypertension compared to intervention by a dietician alone

Conditions and MedDRA coding

Idiopathic Intracranial Hypertension

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. New-onest definite idiopathic intracranial hypertension with papilledema and lumbar opening pressure >= 25 cm cerebrospinal fluid
2. Female aged 18-65 years
3. BMI >= 27
4. Written informed consent
5. Current use or consent to initiate the use of contraceptive methods with failure rates of less than 1 % throughout the study period if randomized to group A including at least an additional 2 months after cessation of Semaglutide® (including hormonal contraceptives (oral, transdermal, vaginal ring, injections), intrauterine devices (hormonal or copper), permanent sterilized partner or credible sexual abstinence e.g. for religious or cultural reasons.

Exclusion criteria 9

1. Unable to provide written informed consent or participate
2. Malignant IIH with visual threat that requires VP-shunting, optic nerve sheet fenestration or other surgical CSF diversion
3. Pregnancy or breastfeeding
4. Treatment with antidiabetics, blood-thinners or medication that may increase the risk of adverse events
5. Diabetes, congestive heart failure, severe vascular disease, pancreatitis, severe ophthalmological disorders other than IIH (e.g., retinopathy)
6. History or family history of thyroid carcinomas or other MEN1/MEN2 carcinomas
7. History of bariatric surgery
8. Known hypersensitivity to any contents of Semaglutide®
9. Other severe/uncontrolled mental or physical disease

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Change in lumbar opening pressure after 8 weeks
2. Change in body weight after 8 weeks

Secondary endpoints 20

1. Change in lumbar opening pressure after 10 months
2. Change in body weight after 10 months
3. Degree of papilledema (Frisén grade)
4. Visual field perimetric mean deviation (MD) by automated perimetry
5. Optical coherence tomography (OCT) changes including enhanced depth imaging (EDI) OCT, confocal scanning laser ophthalmoscopy (cSLO) and OCT angiography (OCTA)
6. Optic disc elevation (ODE) and optic nerve sheath diameter (ONSD) by transorbital ultrasonography
7. HURT score (Headache Under Response to Treatment)
8. Number of monthly headache days
9. Mean monthly headache intensity
10. Need of prophylactic and acute headache medication
11. Percentage in full or partial remission after 10 months (absence of papilledema with or without ICP < 25 cm CSF, respectively)
12. Body fat percentage and truncal adiposity (8 weeks and 10 months DEXA scan)
13. Quality of life (WHO QoL questionnaire short version, 8 weeks and 10 months)
14. Drop-out before 8 weeks and 10-month follow-up
15. Urinary ketosis
16. Use of ICP regulating medication including Acetazolamide, Topiramate, diuretics (daily dose and length of treatment)
17. 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.)
18. Adverse events and reactions
19. Presence of non-alcoholic fatty liver disease (NAFLD) (8 weeks and 10 months) assessed by ultrasonography
20. Concentratoin Semaglutide in cerebrospinal fluid

Investigational products

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

Test 5

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Rigshospitalet

Sponsor organisation

Rigshospitalet

Address

Valdemar Hansens Vej 1-23

City

Glostrup

Postcode

2600

Country

Denmark

Scientific contact point

Organisation

Rigshospitalet

Contact name

Danish Headache Center

Public contact point

Organisation

Rigshospitalet

Contact name

Danish Headache Center

Third parties 1

Locations

1 EU/EEA country · 2 investigational sites

By country

Investigational sites

Country notifications

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

Results and documents

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

Documents 8 files

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

Application history

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