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New treatment option for Monogenic Obesity
Official title A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults
ClinicalTrials.gov ID: NCT07220772
What this study is testing
What is Mibavademab?
Mibavademab is an investigational medicine, being studied as a potential treatment for monogenic obesity.
Also referred to as REGN4461.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is researching an experimental drug called mibavademab. The study is focused on patients with a condition called monogenic obesity.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 and older
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 Key
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...
- 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...
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 Key
- 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...
- 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 Inclusion/Exclusion Criteria Apply
The study team makes the final eligibility decision.
Where it's taking place
- Ulm, Germany
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, 2 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ulm, Germany. 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 ClinicalTrials.gov; the study team decides eligibility.