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Recruiting NCT07220772

A Study Evaluating Mibavademab Treatment of Obesity Due to Leptin (LEP) Gene Mutations in Children, Adolescents and Adults

Phase III Interventional Monogenic Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mibavademab.
Who it may be relevant to
Registry conditions: Monogenic Obesity. Basic parameters: from 2 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Germany
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label Study of Mibavademab (REGN4461), a Leptin Receptor Agonist, for the Treatment of Monogenic Obesity Due to Biallelic Loss of Function Variants of the LEP Gene

Overview

This study is researching an experimental drug called mibavademab. The study is focused on patients with a condition called monogenic obesity. Monogenic obesity is caused by a change in the leptin gene that keeps it from working properly. This causes the body to not be able to feel full or control feelings of hunger. The aim of the study is to see how well mibavademab controls the body weight and how safe it is. The study is looking at several other research questions, including: * How much mibavademab is in the blood at different times * Whether the body makes proteins called antibodies against mibavademab (which could stop mibavademab from working as well or could lead to side effects) * What side effects may happen from taking mibavademab

Interventions

  • Drug Mibavademab
    Administered as per the protocol

Primary outcome measures

  • Percent change in Body Mass Index (BMI) [Time frame: Baseline to Week 24]
Secondary outcome measures (12)
  • Percent change in BMI [Time frame: Baseline to Week 52]
  • Absolute change in BMI [Time frame: Baseline, Through Week 52]
  • Percent change in body weight [Time frame: Baseline, Through Week 52]
  • Absolute change in body weight [Time frame: Baseline, Through Week 52]
  • Change in waist circumference [Time frame: Baseline, Through Week 52]
  • Change in absolute total fat mass by whole body DXA [Time frame: Baseline, Through Week 52]
  • Change in percent total fat mass by whole body DXA [Time frame: Baseline, Through Week 52]
  • Change in absolute regional fat mass by whole body DXA [Time frame: Baseline, Through Week 52]
  • Change in percent regional fat mass by whole body DXA [Time frame: Baseline, Through Week 52]
  • Change in scores in the symptoms of hyperphagia questionnaire [Time frame: Baseline, Through Week 52]
  • Change in scores in the impacts of hyperphagia questionnaire [Time frame: Baseline, Through Week 52]
  • Change in scores in the hunger questionnaire [Time frame: Baseline, Through Week 52]

Eligibility criteria

Inclusion 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

Exclusion criteria

  • 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 Inclusion/Exclusion Criteria Apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Germany · 1 center
  • ULM University Medical Centre — Ulm

Identifiers

NCT: NCT07220772 · R4461-MOB-2471 · 2024-518674-14-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗