BridgeMD
Metformin Intervention in children and adolescents with obesity. A parallel, three arms, randomized, 6 months, multi-center study with metformin extended release (XR) plus lifestyle or metformin immediate release (IR) plus lifestyle or lifestyle alone.
EU CTIS ID: 2024-517787-29-00
What this study is testing
To compare the effect between metformin extended release (XR) plus lifestyle, and lifestyle alone on the BMI-SDS change, from baseline to the 6 months visit at end of treatment.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Signed informed consent prior to any study-specific procedures.
- Males or females of age 6 to less than 17 years and 3 months at the time of signing informed consent.
- Body weight ≥ 40 kg.
- Obesity (BMI-SDS >2.0) according to WHO.
- Stable body weight during previous 90 days before screening visit 1 (< 5kg measured or self-reported weight change).
- If female of childbearing potential: Not sexually active or usage of adequate anticonception and having negative pregnancy tests. Methods that can achieve a failure rate of less than 1% per year (Pearl index <1), when used consistently and correctly, are considered as highly effective birth control methods. Such methods include: •Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal. •Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable. •Intrauterine device (IUD). • Intrauterine hormone-releasing system (IUS). • Bilateral tubal occlusion. • Vasectomised partner. • Sexual abstinence (if refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the preferred and usual lifestyle).
You likely can't join if
- Known syndromal obesity (e.g. Prader-Willi syndrome, Bardet-Biedl syndrome or Laurence-Moon syndrome).
- Severe sleep apnea, as judged by investigator.
- Chronic disease, as judged by investigator.
- Any concomitant medication influencing blood glucose (e.g. metformin and acarbose), influencing other parameters of metabolic syndrome (e.g. orlistat) or interfering with the investigational medicinal product from 3 months prior to screening until the end of the treatment period at visit 11.
- Steroid treatment (oral or injected).
- Antidepressants that can lead to weight gain, as judged by investigator.
See the full eligibility criteria
Who can join
- Signed informed consent prior to any study-specific procedures.
- Males or females of age 6 to less than 17 years and 3 months at the time of signing informed consent.
- Body weight ≥ 40 kg.
- Obesity (BMI-SDS >2.0) according to WHO.
- Stable body weight during previous 90 days before screening visit 1 (< 5kg measured or self-reported weight change).
- If female of childbearing potential: Not sexually active or usage of adequate anticonception and having negative pregnancy tests. Methods that can achieve a failure rate of less than 1% per year (Pearl index <1), when used consistently and correctly, are considered as highly effective birth control methods. Such methods include: •Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal. •Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable. •Intrauterine device (IUD). • Intrauterine hormone-releasing system (IUS). • Bilateral tubal occlusion. • Vasectomised partner. • Sexual abstinence (if refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the preferred and usual lifestyle).
What rules you out
- Known syndromal obesity (e.g. Prader-Willi syndrome, Bardet-Biedl syndrome or Laurence-Moon syndrome).
- Severe sleep apnea, as judged by investigator.
- Chronic disease, as judged by investigator.
- Any concomitant medication influencing blood glucose (e.g. metformin and acarbose), influencing other parameters of metabolic syndrome (e.g. orlistat) or interfering with the investigational medicinal product from 3 months prior to screening until the end of the treatment period at visit 11.
- Steroid treatment (oral or injected).
- Antidepressants that can lead to weight gain, as judged by investigator.
- Unstable treatment for neuropsychiatric disorders such as ADHD/ADD, and/or treatment started within 3 months prior to screening visit.
- Known hypersensitivity to metformin or any of the excipients.
- Language difficulties, impaired mental ability or not willing to understand or comply with the study procedures.
- Participation in another clinical study involving an Investigational Medicinal Product (IMP) within three months prior to screening.
- Subject from the same household participating in this trial.
- Pregnancy or lactation.
- Indigestion-causing diseases.
- Severe gastrointestinal disease, as judged by investigator.
- Total or partial gastric or small intestine resection.
- Type 1 diabetes mellitus.
- Kidney disease or renal dysfunction, acute or chronic (eGFR <60ml/min/1,73m2 ).
- Hypo-/hyperthyroidism, unless stable treatment.
- Severe depression, severe anxiety or other psychiatric disorder referred to or undergoing special treatment, as judged by investigator.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.