Metabolic Effects of Melanocortin 4 Receptor Agonism

黑皮质素 4 受体激动剂的代谢效应

• 批准号: 8741634
• 负责人: Monica Skarulis
• 金额: $ 43.61万
• 依托单位: NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/8741634
• 关键词: Admission activity; Agonist; Body Weight; Brain region; Carbohydrates; Clinical Research; Corticotropin; Cross-Over Studies; Data; Desire for food; Diet; Dose; Double-Blind Method; Drug Kinetics; Eating; Energy Metabolism; Enrollment; Equilibrium; Evaluation; Exclusion Criteria; Exercise; Family; Fatty acid glycerol esters; Food; Homeostasis; Hour; Infusion procedures; Measures; Melanocortin 4 Receptor; Melanocyte stimulating hormone; Metabolic; Obesity; Peptides; Placebo Control; Placebos; Pro-Opiomelanocortin; Process; Proteins; Randomized; Randomized Controlled Trials; Regulation; Rest; Safety; Sleep; System; Weight; Weight Gain; Woman; alternative treatment; feeding; insulin sensitivity; meetings; melanocortin receptor; novel; peptide hormone; preclinical study; proliferative phase Menstrual cycle; screening; treatment duration; volunteer; weight maintenance

This is a randomized, double-blind, placebo-controlled, multiple-dose, 2-period, crossover study during which 12 obese subjects will be enrolled, and randomized to one of 2 treatment sequences (melanocortin 4 receptor agonist, RM-493 then placebo; or placebo, then RM-493) over an 8-day study interval. Energy expenditure will be measured in a room calorimeter, and safety and pharmacokinetic data will also be collected. Volunteers meeting all inclusion and none of the exclusion criteria during the screening process will be admitted to the Metabolic Clinical Research Unit (MCRU) for a period of 8 days. Admission should be within 45 days of screening unless a longer period is required for a woman to reach the follicular phase of the menstrual cycle (day 1 through 7). During the 8-day study interval, volunteers will be provided a nutritionally balanced (50% carbohydrate, 30% fat, 20% protein) weight maintenance diet. After baseline evaluation, the subjects will initiate a 3-day treatment period (Period 1) with their first study treatment by continuous SC infusion. During this three day period, subjects will spend 24 hours in the metabolic chamber (from the morning of Day 4 through the morning of Day 5). After the completion of the final assessments on the morning of Day 5, subjects will enter the second 3-day treatment period (Period 2) in which identical evaluations will occur as in Period 1, with the exception that they will receive the alternative treatment. On the morning of Day 8, after completion of the final assessments of Period 2, subjects will complete the study and be discharged.

这是一项随机，双盲，安慰剂对照，多剂量，2期，跨界研究，在此期间将招募12名肥胖受试者，并随机分为2个治疗序列之一（黑色素质素4受体激动剂，RM-493，然后是安慰剂；然后安慰剂；然后安慰剂，然后是安慰剂，然后是RM-493）。 能量支出将在房间量热计中测量，还将收集安全和药代动力学数据。 符合所有包容性的志愿者，在筛查过程中没有任何排除标准将被送入代谢临床研究部（MCRU）为期8天。 入院应在筛查后的45天内进行，除非妇女需要更长的时间到达月经周期的卵泡阶段（第1至第7天）。 在为期8天的研究间隔中，将为志愿者提供营养平衡（50％碳水化合物，30％脂肪，20％蛋白质）体重维持饮食。 在基线评估后，受试者将通过连续的SC输注进行第一次研究治疗，开始为期3天的治疗期（周期1）。 在这三天期间，受试者将在代谢室（从第四天的早晨到第五天的早晨）在代谢室中度过24小时。 在第5天的早晨完成最终评估后，受试者将进入第二三天治疗期（周期2），在该期间将与周期1进行相同的评估进行，但他们将接受替代治疗。 在第2天的第8天早晨完成第2期的最终评估后，受试者将完成研究并被解除。