Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ended
Participants planned
24
Countries
1
Sites
1
Obesity, Non-alcoholic Fatty Liver Disease
We aim to investigate the changes in very low-density lipoproteins- and triglycerides (VLDL-TG) kinetics before, during, and after extensive weight loss in women diagnosed with both obesity and non-alcoholic fatty liver disease.
Key facts
- Sponsor
- Region Midtjylland
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Trial duration
- 18 Dec 2023 → 26 Feb 2026
- Decision date (initial)
- 2023-08-28
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Department of Hepatology and Gastroenterology, Aarhus University Hospital · Klinisk Institut, Aarhus Universitet · Steno Diabetes Center Aarhus, Aarhus Universitets Hospital
External identifiers
- EU CT number
- 2023-506300-12-00
- WHO UTN
- U1111-1292-1869
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
We aim to investigate the changes in very low-density lipoproteins- and triglycerides (VLDL-TG) kinetics before, during, and after extensive weight loss in women diagnosed with both obesity and non-alcoholic fatty liver disease.
Secondary objectives 1
- To study the changes in VLDL-TG kinetics between the two intervention arms during weight loss and 8 months after treatment initiation.
Conditions and MedDRA coding
Obesity, Non-alcoholic Fatty Liver Disease
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | PT | 10029883 | Obesity | 100000004861 |
| 22.0 | LLT | 10029530 | Non-alcoholic fatty liver | 10019805 |
| 22.0 | PT | 10053219 | Non-alcoholic steatohepatitis | 100000004871 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Treatment arms Short description of the treatment arms. Please see the study protocol for in-depth description.
|
Randomised Controlled | None | Wegovy: Wegovy will be brought from the Hospital pharmacy, Aarhus University Hospital, Region Midtjylland in the form of prefilled pens of Wegovy® Flextouch® injection fluid in doses 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg and 2.4 mg, 4 doses in each pen. The 12 subjects randomised to Wegovy will undergo dose escalation over 16 weeks: 0.25 mg once weekly for 4 weeks, 0.5 mg once weekly for 4 weeks, 1.0 mg once weekly for 4 weeks, 1.7 mg once weekly for 4 weeks, then the dose will be increased to the target dose of 2.4 mg once weekly, meanwhile, the subjects will receive counseling regarding lifestyle intervention (hypocaloric diet with a daily deficit of 500 kcal and advice on physical activity of 150 minutes per week). Roux-en-Y Gastric Bypass: The 12 subjects randomized for treatment with Roux-en-Y Gastric Bypass (RYGB) will be referred to the Surgical Department at Viborg Regional Hospital, Region Midtjylland. RYGB is a laparoscopic procedure that combines a small stomach pouch with a partial bypass of the small intestine. The study participants will receive regular follow-up through SDCA, including counseling on lifestyle intervention and advice on physical activity of 150 minutes per week. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 1. Women who meet the Danish health authorities' criteria for being offered surgical treatment of severe obesity, which are: (i) Body mass index (BMI) over 35 and at least one of the following comorbidities: osteoarthritis in the lower extremities, documented sleep apnea, or severe uncontrolled hypertension, or (ii) extreme obesity with BMI over 50., 2. Age above 18., 3. Understands and speaks Danish., 4. Either MRS/MRI-PDFF with more than 5% steatosis in the liver or a CAP greater than 280 dB/m.
Exclusion criteria 1
- 1., Treatment with GLP-1ra within the last 6 months., 2. Type 1 diabetes or type 2 diabetes (fasting blood sugar over 7 mmol/L, non-fasting blood sugar over 11.1 mmol/L. or HbA1c >48). , 3. Alcohol consumption of more than 20 g/day, equivalent to approximately 1.5 standard drinks daily., 4. Known liver disease other than MASLD., 5. Known polycystic ovary syndrome., 6. Other uncontrolled medical condition (e.g., thyroid disease) assessed by the investigators., 7. Kidney disease GFR < 30 mL/min/1,73 m2., 8. Weight above 170 kg, shoulder width measured at the widest point above 65 cm, or circumference above 160 cm measured at the participant's widest point (as they would not be able to undergo MRS/MRI-PDFF and RYGB without prior weight loss). 9., Recent weight loss or weight gain exceeding 5% of body weight. 10., Contraindication to RYGB (Roux-en-Y gastric bypass)., 11. Pregnancy or women not using reliable contraception., 12. Liver cirrhosis, either known or suspected based clinical and/or biochemical parameters., 13. Allergy to ingredients in Wegovy®.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Changes in VLDL-TG kinetics 8 months after treatment initiation, when their weight loss has stabilized: I) Changes in relation to the degree of weight loss. II) Changes in relation to the amount of fat in the liver, assessed by MRI-PDFF.
Secondary endpoints 1
- Changes between the groups in: I) Hepatic secretion of VLDL-TG particles, II) Glucose kinetics, III) Palmitate kinetics, IV) Circulating lipids, V) Insulin resistance, VI) Inflammatory markers, VII) Gut microbiota and metabolites, VIII) The Fibrosis-4 index (FIB-4), IX) NAFLD fibrosis score (NFS), X) Inflammatory markers in blood, gut, liver, fat, and muscle XI) Histology and gene expression in adipose tissue XII) Muscle mass and muscle structure and in histology and gene expression.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Wegovy 2.4 mg FlexTouch solution for injection in pre-filled pen
PRD9862226 · Product
- Active substance
- Semaglutide
- Substance synonyms
- NNC0113-0217
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 0.34 mg milligram(s)
- Max total dose
- 50 mg milligram(s)
- Max treatment duration
- 32 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BJ06 — -
- Marketing authorisation
- EU/1/21/1608/011
- MA holder
- NOVO NORDISK A/S
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Region Midtjylland
- Sponsor organisation
- Region Midtjylland
- Address
- Palle Juul-Jensens Boulevard 99
- City
- Aarhus N
- Postcode
- 8200
- Country
- Denmark
Scientific contact point
- Organisation
- Region Midtjylland
- Contact name
- David Haldrup
Public contact point
- Organisation
- Region Midtjylland
- Contact name
- David Haldrup
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Aarhus Universitet ORG-100028380
|
Aarhus N, Denmark | On site monitoring |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 24 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2023-12-18 | 2024-04-15 | 2025-06-23 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 10 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | The WILD study protokol NVK | 4.1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements | 3 |
| Subject information and informed consent form (for publication) | Bilag 3 Forsoegspersoners rettigheder NVK | 1 |
| Subject information and informed consent form (for publication) | informed consent form | 2.1 |
| Subject information and informed consent form (for publication) | Informed consent muscle biopsies | 2.1 |
| Subject information and informed consent form (for publication) | Patient information | 4.2 |
| Subject information and informed consent form (for publication) | Samtykke erklring Wegovy biopsier | 1 |
| Subject information and informed consent form (for publication) | Wild information v4.1 track changes | 4.1 |
| Summary of Product Characteristics (SmPC) (for publication) | Wegovy SmPc | 1 |
| Synopsis of the protocol (for publication) | Synopsis of the WILD study protocol | 1.1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-06-13 | Denmark | Acceptable 2023-08-25
|
2023-08-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2023-10-09 | Denmark | Acceptable 2023-11-10
|
2023-11-24 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2024-04-15 | Denmark | Acceptable 2023-11-10
|
2024-04-15 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-03-09 | Denmark | Acceptable 2025-04-16
|
2025-04-25 |