NCT05093634已完成3 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial: Multiple Independent Sub-studies of Setmelanotide in Patients With POMC/PCSK1, LEPR, NCOA1(SRC1), or SH2B1 Gene Variants in the Melanocortin-4 Receptor Pathway
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
- 296
- 试验地点
- 104
- 主要终点
- Difference in mean change in body weight in patients treated with setmelanotide compared to placebo, assessed as percent change in BMI
研究概览
简要总结
The protocol describes a randomized, double-blind, placebo-controlled trial with independent sub-studies of setmelanotide in patients with obesity and at least one of the specific gene variants in the Melanocortin-4 Receptor pathway:
- POMC or PCSK1 (Sub-study 035a)
- LEPR (Sub-study 035b)
- SRC1 (Sub-study 035c)
- SH2B1 (Sub-study 035d)
The objectives and endpoints are identical for these sub-studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must have a pre-identified:
- •Heterozygous genetic variant in the POMC gene or PCSK1 gene
- •Heterozygous genetic variant in the LEPR gene
- •Homozygous, heterozygous, or compound heterozygous variant in the NCOA1 (SRC1)
- •Homozygous, heterozygous, or compound heterozygous variant in SH2B1 gene, or chromosomal 16p11.2 deletion encompassing the SH2B1 gene
- •Between 6 and 65 years of age at the time of provision of informed consent/assent
- •Obesity, defined as BMI ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and gender for patients 6 up to 17 years of age
- •Patient and/or parent or guardian is able to understand and comply with the requirements of the study and is able to understand and sign the written informed consent/assent
- •Patient and/or parent or guardian reports that patient experienced childhood obesity, defined as the patient and/or parent or guardian reporting that the patient was significantly overweight during childhood
- •Agree to use a highly effective form of contraception throughout the study and for 90 days following the study
- •Reported history of lifestyle intervention of diet and exercise
- •Reported history of hyperphagia
排除标准
- •Weight loss of 2% or greater in the previous 3 months
- •Recent history of bariatric surgery
- •Significant psychiatric disorder(s)
- •Suicidal ideation, attempt or behavior
- •Clinically significant pulmonary, cardiac, endocrine/metabolic, hepatic or oncologic disease
- •Glycated hemoglobin (HbA1C) >10% at Screening
- •History of significant liver disease or severe kidney disease
- •History or close family history (parents or siblings) of melanoma, or patient history of oculocutaneous albinism
- •Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
- •Participation in any clinical study with an investigational drug/device within 3 months prior to the first day of dosing
- •Previously enrolled in a clinical study involving setmelanotide or any previous exposure to setmelanotide
- •Significant hypersensitivity to any excipient in the study drug
- •If female, pregnant or breastfeeding
研究组 & 干预措施
POMC or PCSK1 variant
Experimental
1:1 Randomization
干预措施: Placebo (Drug)
LEPR variant
Experimental
1:1 Randomization
干预措施: Placebo (Drug)
NCOA1 (SRC1) variant
Experimental
1:1 Randomization
干预措施: Placebo (Drug)
SH2B1 variant
Experimental
1:1 Randomization
干预措施: Placebo (Drug)
NCOA1 (SRC1) variant
Experimental
1:1 Randomization
干预措施: Setmelanotide (Drug)
POMC or PCSK1 variant
Experimental
1:1 Randomization
干预措施: Setmelanotide (Drug)
LEPR variant
Experimental
1:1 Randomization
干预措施: Setmelanotide (Drug)
SH2B1 variant
Experimental
1:1 Randomization
干预措施: Setmelanotide (Drug)
结局指标
主要结局
Difference in mean change in body weight in patients treated with setmelanotide compared to placebo, assessed as percent change in BMI
时间窗: Baseline to 52 weeks
次要结局
- The proportion of patients who achieve at least 5% reduction in BMI in patients treated with setmelanotide compared to placebo(Baseline to 52 weeks)
- The difference in mean change in body weight in adult patients treated with setmelanotide compared to placebo, assessed as percent change in baseline body weight(Baseline to 52 weeks)
- The difference in mean percent change in the weekly average most hunger score in patients treated with setmelanotide compared to placebo(Baseline to 52 weeks)
- The proportion of patients who achieve at least 10% reduction in BMI in patients treated with setmelanotide compared to placebo(Baseline to 52 weeks)
研究者
研究点 (104)
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