Identify the Expanded Access Program, if Any. This is Required Unless the Expanded Access Type is "Individual Patients." A Randomized, Parallel, Double-blind, Placebo-controlled Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of JMT206 Injection Alone or in Combination With Semaglutide in Obese Participants
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AE) assessed by CTCAE v6.0
研究概览
简要总结
Use these resources to provide understandable information about this study to patients, families, and health care providers:
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18~65 (including threshold values), male or female participants;
- •BMI ≥ 30 kg/m²;
- •Weight change <5% within the 3 months prior to screening
- •Voluntarily sign the informed consent form before the trial..
排除标准
- •1) Those known to have a history of allergy to any component or related preparations in the investigational drug and its excipients, or have severe allergic diseases or allergic constitution; 2) Participants with a history of diabetes mellitus or hypoglycemic episodes; 3) Obesity is related to medication or diseases; Or weight gain caused by non-fat content; or monogene mutationsobesity; 4) History of weight loss surgery and/or treatment within the past year; 5) History of severe gastrointestinal disease or gastrointestinal surgery, clinically significant gastric emptying abnormalities, or long-term use of medications directly affecting gastrointestinal motility; 6) Having comorbidities known to affect skeletal muscle proteins; 7) A history of acute or chronic pancreatitis; 8) Acute gallbladder disease within one year prior to screening; 9) Previous or family history of medullary thyroid carcinoma or type 2 endocrine adenomatosis; 10) Severe cardiovascular or cerebrovascular events within 6 months prior to screening; 11) Any type of treated or untreated malignant tumor within 5 years prior to screening; 12) History of severe mental illness; 13) Use of drugs or products that may cause weight changes within 3 months prior to screening; 14) Use of drugs or products affecting skeletal muscle synthesis within 3 months prior to screening; 15) Participants deemed otherwise unsuitable for this trial by the investigator.
研究组 & 干预措施
JMT206 injection group 2
JMT206 injection dose 2 administered subcutaneously (SC) once a week
干预措施: JMT206 injection (Drug)
JMT206 injection group 3
JMT206 injection dose 3 administered subcutaneously (SC) once a week
干预措施: JMT206 injection (Drug)
JMT206 injection + Semaglutide group 1
JMT206 injection dose 1 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased.
干预措施: Semaglutide injection (Combination Product)
JMT206 injection + Semaglutide group 1
JMT206 injection dose 1 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased.
干预措施: JMT206 injection (Drug)
JMT206 injection + Semaglutide group 2
JMT206 injection dose 2 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased.
干预措施: JMT206 injection (Drug)
JMT206 injection + Semaglutide group 3
JMT206 injection dose 3 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased
干预措施: JMT206 injection (Drug)
Placebo
Placebo administered subcutaneously (SC) once a week
干预措施: Placebo injection (Drug)
Placebo+ Semaglutide
Placebo administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased.
干预措施: Placebo injection (Drug)
JMT206 injection group 1
JMT206 injection dose 1 administered subcutaneously (SC) once a week
干预措施: JMT206 injection (Drug)
Placebo+ Semaglutide
Placebo administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased.
干预措施: Semaglutide injection (Combination Product)
JMT206 injection + Semaglutide group 2
JMT206 injection dose 2 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased.
干预措施: Semaglutide injection (Combination Product)
JMT206 injection + Semaglutide group 3
JMT206 injection dose 3 administered subcutaneously (SC) once a week. Semaglutide administered subcutaneously once a week, starts from lower dose and is gradually increased
干预措施: Semaglutide injection (Combination Product)
结局指标
主要结局
Incidence of Adverse Events (AE) assessed by CTCAE v6.0
时间窗: Baseline through week 19
次要结局
未报告次要终点