A Study Investigating Safety, Tolerability and Efficacy of UBT251 in Participants Living With Overweight or Obesity
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 333
- 试验地点
- 3
- 主要终点
- Part A - Number of treatment emergent adverse events (TEAEs)
研究概览
简要总结
The purpose of this clinical study is to find out if UBT251 is safe and effective for treating people who are living with overweight or obesity. Participants will get either UBT251 (the treatment being tested) or Placebo (a treatment that has no active medicine in it), which treatment participants get is decided by chance.
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, Investigator)
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
- •Male or female (sex at birth).
- •For Part C: Japanese, Chinese or non-Asian participants (all self-reported):
- •For Japanese participants: both parents of Japanese descent.
- •For Chinese participants: both parents of Chinese descent.
- •For non-Asian participants: both parents of non-Asian descent (non-Asian is defined as of countries outside of Asia).
- •Age at the time of signing the informed consent:
- •For Part A: 18-55 years (both inclusive)
- •For Part B: 18-65 years (both inclusive)
- •For Part C: 18-55 years (both inclusive).
- •BMI at screening (overweight and obesity should be due to excess adipose tissue, as judged by the investigator):
- •For Part A: 27.0-39.9 kilogram per meter square (kg/m^2) (both inclusive)
- •For Part B: 30.0-50.0 kg/m^2 (both inclusive)
- •For Part C: 24-34.9 kg/m^2 (both inclusive)
- •Considered eligible based on the medical history, physical examination, and the results of vital signs, electrocardiogram (ECG), and clinical laboratory tests performed during the screening visit, as judged by the investigator.
排除标准
- •Known or suspected hypersensitivity to study intervention(s) or related products.
- •Treatment with any marketed product containing compounds with glucagon-like peptide 1 (GLP-1), glucose-dependent insulinotropic polypeptide (GIP) or glucagon receptor agonism within 90 days before screening.
- •Any condition, unwillingness or inability, which in the investigator's opinion might jeopardise the participant's safety or compliance with the protocol.
研究组 & 干预措施
Part A - UBT251
Participants will be randomized to receive multiple dose levels subcutaneously.
干预措施: UBT251 (Drug)
Part B - Arm E (UBT251)
Participants will be randomized to receive a single dose level subcutaneously.
干预措施: UBT251 (Drug)
Part B - placebo
Participants will receive placebo matching one of the UBT251 arms subcutaneously.
干预措施: Placebo (Drug)
Part B - Arm D (UBT251)
Participants will be randomized to receive 2 dose levels subcutaneously.
干预措施: UBT251 (Drug)
Part B - Arm A (UBT251)
Participants will be randomized to receive multiple dose levels subcutaneously.
干预措施: UBT251 (Drug)
Part C - UBT251 dose 1
Participants will be randomized to receive dose level 1 subcutaneously.
干预措施: UBT251 (Drug)
Part C - UBT251 dose 2
Participants will be randomized to receive dose level 2 subcutaneously.
干预措施: UBT251 (Drug)
Part C - UBT251 dose 3
Participants will be randomized to receive dose level 3 subcutaneously.
干预措施: UBT251 (Drug)
Part B - Arm C (UBT251)
Participants will be randomized to receive multiple dose levels subcutaneously.
干预措施: UBT251 (Drug)
Part A - placebo
Participants will receive placebo matched to UBT251 subcutaneously.
干预措施: Placebo (Drug)
Part B - Arm B (UBT251)
Participants will be randomized to receive multiple dose levels subcutaneously.
干预措施: UBT251 (Drug)
结局指标
主要结局
Part A - Number of treatment emergent adverse events (TEAEs)
时间窗: From baseline (week 0) to end of study (week 33)
Measured as Number of events.
Part B - Relative change in body weight
时间窗: From baseline (week 0) to end of treatment (week 28)
Measured as percentage of body weight.
Part C- AUC; the area under the UBT251 plasma concentration time curve
时间窗: From pre-dose on Day 1 until completion of the end of study visit (Day 43)
Measured as hour\*nanomoles per liter (h\*nmol/L)
次要结局
- Part A - Relative change in body weight(From baseline (week 0) to end of treatment (week 28))
- Part A - Change in body weight(From baseline (week 0) to end of treatment (week 28))
- Part A - AUC; the area under the UBT251 plasma concentration-time curve(From pre-dose on day 1 to end of study (week 33))
- Part A - Cmax; the maximum plasma concentration of UBT251(From pre-dose on day 1 to end of study (week 33))
- Part B - Change in body weight(From baseline (week 0) to end of treatment (week 28))
- Part B - Change in waist circumference(From baseline (week 0) to end of treatment (week 28))
- Part B - Number of TEAEs(From baseline (week 0) to end of study (week 33))
- Part C - Cmax; the maximum plasma concentration of UBT251(From pre-dose on Day 1 until completion of the end of study visit (Day 43))
- Part C - Number of treatment-emergent adverse events (TEAEs)(From pre-dose on Day 1 until completion of the end of study visit (Day 43))