NCT07220772招募中3 期
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
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Percent change in Body Mass Index (BMI)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Mibavademab
Experimental
干预措施: Mibavademab (Drug)
结局指标
主要结局
Percent change in Body Mass Index (BMI)
时间窗: Baseline to Week 24
次要结局
- Percent change in BMI(Baseline to Week 52)
- Absolute change in BMI(Baseline, Through Week 52)
- Percent change in body weight(Baseline, Through Week 52)
- Absolute change in body weight(Baseline, Through Week 52)
- Change in waist circumference(Baseline, Through Week 52)
- Change in absolute total fat mass by whole body DXA(Baseline, Through Week 52)
- Change in absolute regional fat mass by whole body DXA(Baseline, Through Week 52)
- Change in scores in the hunger questionnaire(Baseline, Through Week 52)
- Number of treatment-emergent adverse events (TEAEs)(Through Week 65)
- Change in percent total fat mass by whole body DXA(Baseline, Through Week 52)
- Change in percent regional fat mass by whole body DXA(Baseline, Through Week 52)
- Change in scores in the symptoms of hyperphagia questionnaire(Baseline, Through Week 52)
- Change in scores in the impacts of hyperphagia questionnaire(Baseline, Through Week 52)
- Severity of TEAEs(Through Week 65)
- Concentrations of total mibavademab in serum(Through Week 65)
- Incidence of anti-drug antibody (ADA) to mibavademab(Through Week 65)
- Titer of ADA to mibavademab(Through Week 65)
研究者
研究点 (1)
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