Overview
Sponsor-declared trial summary
Precocious puberty and overweight
To determine the effects of either insulin sensitization during Metformin treatment or changes in body composition during lifestyle intervention for 6 months on bone age as a marker of pubertal maturation in girls with overweight and early puberty.
Key facts
- Sponsor
- Herlev Hospital
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Trial duration
- 27 Aug 2024 → ongoing
- Decision date (initial)
- 2024-04-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-511009-50-00
- ClinicalTrials.gov
- NCT05957991
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacodynamic, Therapy
To determine the effects of either insulin sensitization during Metformin treatment or changes in body composition during lifestyle intervention for 6 months on bone age as a marker of pubertal maturation in girls with overweight and early puberty.
Secondary objectives 1
- 1. To determine the effects of metformin and/or lifestyle intervention over 6 months on breast development, height velocity, sex hormones, insulin sensitivity, metabolic markers, fitness level and body composition. 2. To determine the effects of the intervention on age at menarche.
Conditions and MedDRA coding
Precocious puberty and overweight
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- • Girls aged 8-9.5 years • Breast development on clinical examination (≥Tanner B2) • GnRH test with stimulated LH>5 IU/l or non-stimulated LH>3 IU/L • BMI > 91st percentile/+1.34 SDs • Premenarcheal
Exclusion criteria 1
- • Known or suspected hypersensitivity or allergy to Metformin • Diabetes Mellitus (type 1 or 2) • Previous or active malignancy • Cardiac, pulmonary, hepatic, or renal diseases associated with significant decompensation • Psychological problems likely to lead to significant non-compliance
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Changes in bone age over 1 year
Secondary endpoints 1
- • Breast development • Sex hormones • HOMA-IR (calculated from fasting insulin and glucose) • Metabolic markers • Body composition • Fitness level • Blood pressure and resting heart rate• Daily physical activity energy expenditure • Quality of Life • Age at menarche
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Metformin "Zentiva", filmovertrukne tabletter
PRD9807796 · Product
- Active substance
- Metformin Hydrochloride
- Substance synonyms
- BMS207150, 2-(N,N-DIMETHYLCARBAMIMIDOYL)GUANIDINE HYDROCHLORIDE, 3-(DIAMINOMETHYLIDENE)-1,1-DIMETHYL-GUANIDINE HYDROCHLORIDE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 1000 mg milligram(s)
- Max treatment duration
- 26 Week(s)
- Authorisation status
- Authorised
- ATC code
- A10BA02 — METFORMIN
- Marketing authorisation
- 64429
- MA holder
- ZENTIVA, K.S.
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Placebo to Metformin Zentiva 1000 mg scored tablet
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Herlev Hospital
- Sponsor organisation
- Herlev Hospital
- Address
- Borgmester Ib Juuls Vej 1
- City
- Herlev
- Postcode
- 2730
- Country
- Denmark
Scientific contact point
- Organisation
- Herlev Hospital
- Contact name
- Rikke Beck Jensen
Public contact point
- Organisation
- Herlev Hospital
- Contact name
- Rikke Beck Jensen
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 80 | 5 |
| 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 | 2024-08-27 | 2025-03-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 15 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-511009-50-00 | 1.4 |
| Protocol (for publication) | D1_Protocol_2024-511009-50-00-tc | 1.4 |
| Protocol (for publication) | D1_Protocol_2024-511009-50-00-TC | 1.4 |
| Protocol (for publication) | D3_DMC_EU-CT 2024-511009-50-00 | 1 |
| Protocol (for publication) | D4_Patient facing documents_questionnaire menarche | 1 |
| Protocol (for publication) | D4_Patient facing documents_Questionnaire_WHO-5 | 1 |
| Recruitment arrangements (for publication) | Brev_LIFE-MET_ | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_TC_ | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TC | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_information leaflet_children | 1.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_information leaflet_children_TC | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_smPC Metformin Zentiva | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-511009-50-00 | 1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-27 | Denmark | Acceptable 2024-04-30
|
2024-04-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-19 | |||
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-07-30 | Denmark | Acceptable | 2024-09-02 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-09-09 | Denmark | Acceptable | 2024-10-09 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-09-25 | Denmark | Acceptable 2025-11-19
|
2025-11-19 |