NCT06548100已完成3 期
A Single-Arm, Open-Label, Safety Study in Patients With Generalized Lipodystrophy Switching From Metreleptin to Mibavademab, A Leptin Receptor Agonist Antibody
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Severity of TEAEs
研究概览
简要总结
This study is researching an experimental drug called mibavademab. The study is focused on participants with GLD who have been on metreleptin treatment for at least 6 months with no change in dose for the last 3 months.
The aim of the study is to see how safe and tolerable mibavademab is when switching from treatment with metreleptin.
The study is looking at several other research questions, including:
- What side effects may happen from taking mibavademab
- How much mibavademab is in the blood at different times
- Whether the body makes antibodies against mibavademab (which could make mibavademab less effective or could lead to side effects)
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
- •Diagnosis of congenital or acquired GLD as defined by Multi-Society Practice Guidelines
- •Treatment with metreleptin for ≥6 months at time of screening at a stable dose, defined as no change in dose within the last 3 months prior to screening
- •Generally stable diet (based on participant's recall) and stable medication regimen for diabetes and/or dyslipidemia (in addition to metreleptin), for the last 3 months prior to screening
- •Willing and able to comply with clinic visits and study-related procedures. Participants who are unable/unwilling to self-inject, but are willing to have a capable caregiver inject, are considered eligible
- •Willing and able to provide, or have the treating physician provide, values of HbA1c and fasting triglycerides from at least 6 months prior to screening, as defined in the protocol
排除标准
- •Treatment with over-the-counter or prescription medications for weight loss within 3 months prior to the screening visit
- •Current chronic treatment with high-dose corticosteroids, as defined in the protocol
- •Any malignancy, eg, lymphoma, within the past 1 year, prior to screening visit except for fully treated basal cell or squamous epithelial cell carcinomas of the skin or carcinoma in situ of the cervix or anus
- •Estimated glomerular filtration rate (GFR) of <30 mL/min/1.73 m^2 based on chronic kidney disease epidemiology collaboration (CKD-EPI)/Schwartz equation at screening. Assessment can be repeated once
- •History of heart failure hospitalization, diagnosis of a myocardial infarction, stroke, clinically significant arrhythmia, transient ischemic attack, unstable angina, percutaneous or surgical revascularization procedure, or intracardiac device placement within 3 months before the screening visit, as defined in the protocol
- •Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study, as defined in the protocol
- •NOTE: Other protocol-defined inclusion / exclusion criteria apply
研究组 & 干预措施
mibavademab
Experimental
Patients switching from at least 6 months of therapy with metreleptin to mibavademab.
干预措施: mibavademab (Drug)
结局指标
主要结局
Severity of TEAEs
时间窗: Up to week 68
Incidence of treatment-emergent adverse events (TEAEs)
时间窗: Up to week 68
次要结局
- Change in total insulin dose(Baseline, week 20 and week 52)
- Occurrence of fasting triglycerides <200 mg/dL in participants treated with mibavademab(Baseline, week 20 and week 52)
- Occurrence of HbA1c <7%(Week 20 and week 52)
- Concentrations of total mibavademab in serum(Up to week 68)
- Incidence of neutralizing antibodies (Nabs) to mibavademab(Up to week 68)
- Percent change in fasting triglycerides(Baseline, week 20 and week 52)
- Change in Hemoglobin A1c (HbA1c)(Baseline, week 20 and week 52)
- Occurrence of HbA1c <6.5%(Week 20 and week 52)
- Incidence of anti-drug antibodies (ADAs) to mibavademab(Up to week 68)
- Occurrence of fasting triglycerides <150 mg/dL in participants treated with mibavademab(Baseline, week 20 and week 52)
- Occurrence of requiring therapy with insulin in participants treated with mibavademab(Week 20 and week 52)
- Change in fasting plasma glucose(Baseline, week 20 and week 52)
- Occurrence of fasting triglycerides <500 mg/dL in participants treated with mibavademab(Baseline, week 20 and week 52)
- Titer of ADAs to mibavademab(Up to week 68)
研究者
研究点 (4)
Loading locations...
相似试验
Unknown
1 期
A Clinical Study of PD-L1 Antibody ZKAB001 Combined With Capecitabine in Resected Biliary Tract CancerBiliary Tract CancerNCT04608786Lee's Pharmaceutical Limited10
已完成
3 期
A Study of MabThera (Rituximab) in Participants With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARD) and/or Anti-Tumor Necrosis Factor (Anti-TNF) Therapy.Rheumatoid ArthritisNCT00503425Hoffmann-La Roche215
招募中
1 期
U87 CAR-T in Patients With Advanced Head and Neck TumorsNasopharynx CancerHead and Neck CancerNCT06614686Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd20
Unknown
不适用
A Prospective, Open-label, Single-arm Clinical StudyRecurrent Glioblastoma MultiformeNCT04689087Sun Yat-sen University40
已完成
1 期
A Safety and Efficacy Study Evaluating CS-101 in Subjects With β-Thalassemia MajorBeta-Thalassemia MajorNCT06291961CorrectSequence Therapeutics Co., Ltd9