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A Study Evaluating Mibavademab Treatment of Obesity due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
EU CTIS ID: 2024-518674-14-00
What this study is testing
To evaluate the effect of mibavademab on body weight.
- Therapeutic confirmatory (Phase III)
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
- Has documented medical history of biallelic loss of function variants of the LEP gene prior to the screening visit.
- Has class ≥2 obesity at screening and at baseline, as defined in the protocol.
- NOTE: Other Protocol-defined inclusion criteria apply.
You likely can't join if
- Unwilling or unable to provide, or have the treating physician provide, documented historical weight for at least 6 months prior to screening.
- History of bariatric surgery within approximately the past 12 months of study screening.
- History of weight loss of ≥5% of body weight in approximately the past 3 months of study screening.
- History of genetic causes of obesity other than/in addition to biallelic loss of function variants of the LEP gene.
- History of schizophrenia, bipolar disorder, or other mental illness that, in the opinion of the investigator, might pose a safety risk to participation in a clinical study of an investigational drug.
- Any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) during screening or baseline, or any lifetime history of a suicide attempt, or any lifetime history of suicidal behavior, including ideation.
See the full eligibility criteria
- Has documented medical history of biallelic loss of function variants of the LEP gene prior to the screening visit.
- Has class ≥2 obesity at screening and at baseline, as defined in the protocol.
- NOTE: Other Protocol-defined inclusion criteria apply.
- Unwilling or unable to provide, or have the treating physician provide, documented historical weight for at least 6 months prior to screening.
- History of bariatric surgery within approximately the past 12 months of study screening.
- History of weight loss of ≥5% of body weight in approximately the past 3 months of study screening.
- History of genetic causes of obesity other than/in addition to biallelic loss of function variants of the LEP gene.
- History of schizophrenia, bipolar disorder, or other mental illness that, in the opinion of the investigator, might pose a safety risk to participation in a clinical study of an investigational drug.
- Any suicidal ideation of type 4 or 5 on the Columbia Suicide Severity Rating Scale (C-SSRS) during screening or baseline, or any lifetime history of a suicide attempt, or any lifetime history of suicidal behavior, including ideation.
- Treatment with medications for weight loss or medications with known side effects of weight loss within the past approximately 3 months of study screening.
- Participants currently being treated with metreleptin, or a history of prior treatment with metreleptin as defined in the protocol.
- NOTE: Other Protocol-defined exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Turkey
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Turkey. Enter your location above to see the nearest site and check your eligibility.
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.