A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Various Doses of ZT006 in Overweight and Obese Participants
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 184
- 试验地点
- 13
- 主要终点
- Change in body weight relative to baseline
研究概览
简要总结
This study is being conducted to evaluate the efficacy and safety of ZT006 tablet in participants with overweight and obesity.
In addition to dietary caloric restriction and increased physical activity, study participants will receive either ZT006 tablets or placebo tablets once every morning (placebo looks like ZT006 tablets but has no active pharmaceutical ingredients). For a fair comparison, study participants are assigned to ZT006 or placebo randomly by a computer.
The study consists of a main study and an extension period. The treatment of the main study will last for 28 weeks. ZT006 tablets will be administered daily in an up-titration fashion, i.e. the dose of ZT006 will be gradually increased to reach three target doses (low, medium, high) so that the participants can tolerate its effect. Participants will have 17 clinic visits including one screening visit and one follow-up visit.
The extension study will be conducted only in participants assigned to the low and medium dose groups in the main study. The treatment of the extension period will be 12 weeks.
Female participants who are pregnant, breast-feeding or who plan to become pregnant during the study are not allowed to participate in the study. Pregnancy will be checked by blood or urine tests during the study.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •MAIN STUDY:
- •Inclusion Criteria:
- •Male or female, age between 18 - 65 years (both inclusive) at the time of signing of the informed consent.
- •Body mass index (BMI) greater than or equal to 28 kg/m², or greater than or equal to 24 kg/m²with at least one of the comorbidities: hypertension, hyperlipidemia, pre-diabetes, metabolic dysfunction-associated steatotic liver disease (MASLD) or obstructive sleep apnea-hypopnea syndrome (OSAHS).
- •Having dietary caloric restriction and increased physical activity for ≥3 months, with change in body weight (increase or decrease) no more than 5%, irrespective of medical records.
排除标准
- •Type 1 or type 2 diabetes or other specific types derived from other causes
- •Medical history of acute or chronic pancreatitis
- •Medical history of cholecystitis, gallstone ≤1 cm, or history of symptomatic gallbladder diseases
- •Use of glucagon-like peptide-1 (GLP-1) agonist, dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) or GLP-1/glucagon agonist, or triple GLP-1/GIP/glucagon agonist within 90 days before screening
- •HbA1c ≥ 6.5% or fasting plasma glucose ≥ 7.0 mmol/L at screening
- •Triglyceride ≥ 5.7 mmol/L at screening
- •Calcitonin ≥ 50 ng/L at screening
- •EXTENSION PERIOD:
- •Inclusion Criteria:
- •Assigned to low/medium target dose groups in the main study and having completed week 28 visit in the main study
- •Administration of low/medium target dose ≥ 10 times in the last two weeks in the main study
- •Exclusion Criteria:
- •Participation in the dense PK sampling in the main study
- •BMI ≤18.5 kg/m² at week 28 visit in the main study
研究组 & 干预措施
ZT006 tablet low target dose
administered per os, daily
干预措施: ZT006 (Drug)
ZT006 tablet medium target dose
administered per os, daily
干预措施: ZT006 (Drug)
ZT006 tablet high target dose
administered per os, daily
干预措施: ZT006 (Drug)
placebo of ZT006
administered per os, daily
干预措施: Placebo of ZT006 (Drug)
结局指标
主要结局
Change in body weight relative to baseline
时间窗: Percentage-point from baseline to end of treatment (week 28)
Percentage-point
次要结局
- Proportion of participants who achieved body weight reduction greater than or equal to 5% at week 28(From baseline to end of treatment (week 28))
- Proportion of participants who achieved body weight reduction greater than or equal to 10% at week 28(From baseline to end of treatment (week 28))
- Proportion of participants who achieved body weight reduction greater than or equal to 15% at week 28(From baseline to end of treatment (week 28))
- Change in body weight(From baseline to end of treatment (week 28))
- Change in waist circumference(From baseline to end of treatment (week 28))
- Change in body mass index (BMI)(From baseline to end of treatment (week 28))
- Rate of treatment-emergent adverse events(From baseline to end of study (week 33))
- Rate of serious adverse events(From baseline to end of study (week 33))
- Proportion of participants with positive anti-ZT006 antibody(From baseline to end of treatment (week 33))