Overview
Sponsor-declared trial summary
Phase
Phase III and Phase IV (Integrated)
Status
Authorised, recruitment pending
Participants planned
157
Countries
1
Sites
1
Obesity
Dose response of Mysimba after Roux-and-Y gastric bypass or Gastric Sleeve surgery
Key facts
- Sponsor
- Zuyderland Medisch Centrum Stichting
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06], Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Decision date (initial)
- 2025-01-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Zuyderland Medical Centre
External identifiers
- EU CT number
- 2024-516645-39-01
- EudraCT number
- 2021-002145-15
- ClinicalTrials.gov
- NCT04902625
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Dose response
Dose response of Mysimba after Roux-and-Y gastric bypass or Gastric Sleeve surgery
Secondary objectives 5
- To describe the persistence of therapy of Mysimba after bariatric surgery
- To describe the maximal tolerated dosage
- To study adverse effects of the use of Mysimba
- To monitor and compare weight loss more long term (up to 12 months) after the start of Mysimba in both study groups
- To evaluate eating behaviour in patients with weight regain after bariatric surgery who used Mysimba compared to patients on the regular module according to the YFAS 2.0 questionnaire
Conditions and MedDRA coding
Obesity
Regulatory references
- Plan to share IPD
- No
- IPD plan description
- -
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-516645-39-00 | Applying Mysimba in patients with weight regain after bariatric surgery | Zuyderland Medisch Centrum Stichting |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Patient is ≥18 and <75 years old
- BMI before surgery was ≥ 35.0 kg/m2
- Patient has undergone a primary banded/non-banded Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG)
- Gaining more than 5% weight after reaching plateau phase of lowest weight To be eligible to participate in the control patient cohort for measuring bupropion and hydroxybupropion serum levels a subject must meet all of the following criteria: • Patient is ≥18 and <75 years old • Patient is obese (BMI > 30 kg/m2) • Patient on successful Mysimba steady maintenance dose
Exclusion criteria 9
- Anatomical or surgical abnormalities for which revisional surgery is indicated.
- Use of the following medication Monoamino-oxidase inhibitors (MAO), selective serotonin reuptake inhibitor (SSRI), Tricyclic antidepressants (TCA), haloperidol, risperidone, opioids, antiarrhythmics, betablockers, antiviral medication (HIV)
- Pregnancy or breastfeeding
- Patients suffering from: o unregulated hypertension o a tumour in the central nervous system o severe liver failure o end stage kidney failure
- Patients suffering from or with a history of insults
- Patients with a history of: o bipolar disease o bulimia or anorexia nervosa
- Patients withdrawing from alcohol or benzodiazepines
- Patients with excessive use of alcohol or drugs
- Patients who are not able to understand the informed consent form and patient information.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary objective is to study the effect of naltrexone/bupropion in combination with the BOT module on successful weight loss (>5% weight loss) after 22 weeks compared with the regular BOT module alone, in patients with weight regain after bariatric surgery. Assessment of bodyweight is standard part of treatment.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Mysimba 8 mg/90 mg prolonged-release tablets
PRD2578958 · Product
- Active substance
- Bupropion Hydrochloride
- Pharmaceutical form
- PROLONGED-RELEASE TABLET
- Route of administration
- ORAL
- Max daily dose
- 272 mg milligram(s)
- Max total dose
- 272 mg milligram(s)
- Max treatment duration
- 50 Month(s)
- Authorisation status
- Authorised
- ATC code
- A08AA62 — -
- Marketing authorisation
- EU/1/14/988/001
- MA holder
- OREXIGEN THERAPEUTICS IRELAND LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Zuyderland Medisch Centrum Stichting
- Sponsor organisation
- Zuyderland Medisch Centrum Stichting
- Address
- Henri Dunantstraat 5
- City
- Heerlen
- Postcode
- 6419 PC
- Country
- Netherlands
Scientific contact point
- Organisation
- Zuyderland Medisch Centrum Stichting
- Contact name
- Stichting Zuyderland Medisch Centrum
Public contact point
- Organisation
- Zuyderland Medisch Centrum Stichting
- Contact name
- Stichting Zuyderland Medisch Centrum
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Authorised, recruitment pending | 157 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Zuyderland Medisch Centrum Stichting
Surgery, Henri Dunantstraat 5, 6419 PC, Heerlen
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Mysimbaprotocol_EUCT2024-516645-39-01 | 1.8 |
| Recruitment arrangements (for publication) | K1_Recruitment and Financial Arragements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF AMPWR | 1.9 |
| Summary of Product Characteristics (SmPC) (for publication) | E1 SmPC Mysimba | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-18 | Netherlands | Acceptable 2025-01-17
|
2025-01-17 |