NCT07279194招募中3 期
Efficacy and Safety of HDM1005 Once Weekly in Chinese Participants Without Type 2 Diabetes Who Have Obesity or Are Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind, Placebo-Controlled Trial
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 825
- 试验地点
- 1
- 主要终点
- primary outcome
研究概览
简要总结
This is a 56-week randomized, double blinded, parallel-controlled study evaluating the efficacy andsafety of the HDM1005 in patients with obesity or overweight. Eligible participants will be screened and randomized to different dose group of HDM1005 or the placebo group at a ratio of 1:1:1 , HDM1005 or placebo will be given once weekly for 52 weeks, following by a safety follow up of 4 weeks. All participants received a lifestyle intervention that involved counselling on diet and physical activity.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged ≥18 years at the time of signing informed consent.
- •BMI≥28 kg/m2 or ≥24 kg/m2 and previously diagnosed with at least one of the following weight related comorbidities: hypertension, dyslipidemia, pre-diabetes, obstructive sleep apnea, fatty liver, weight-bearing joint pain.
- •A self-reported change in body weight no more than 5% within 90 days before screening.
- •Able to understand the procedures and methods of this study, willing to strictly comply with the clinical trial protocol to complete this trial, and voluntarily sign the informed consent form.
排除标准
- •Have type 1 diabetes mellitus (T1DM) or T2DM.
- •Have HbA1c≥6.5% or fasting serum glucose (FSG)≥7.0 mmol/L at Visit
- •Have obesity induced by other endocrinologic disorders (for example, Cushing syndrome) or by other medicine.
- •Use of GLP-1 receptor (GLP-1R) agonists or GLP-1R/GCGR agonists or GIPR/GLP-1R agonists or GIPR/GLP-1R/GCGR agonists within 3 months prior to screening.
- •Use of hypoglycemic drugs within 3 months prior to screening.
- •History of thyroid C-cell carcinoma, multiple endocrine neoplasia (MEN) 2A or 2B or relevant family history.
- •Previous history of acute and chronic pancreatitis, acute gallbladder disease history (except cholecystectomy) history.
- •PHQ questionnaire ≥ 15 points at screening or randomization.
- •Have had a history of moderate to severe depression; Or have a history of severe mental illness in the past.
- •Uncontrolled hypertension prior to screening, defined as: systolic blood pressure ≥ 160 mmHg and/or diastolic blood pressure ≥ 100 mmHg (stable for 1 month if using antihypertensive drugs).
- •History of malignancy (except cured basal cell carcinoma) in the past 5 years or at the time of screening.
- •History of severe cardiovascular or cerebrovascular diseases within the past six months.
- •History of alcohol and drug abuse at screening.
- •The participant may be allergic to ingredients in the study drug or drugs of the same class.
- •Pregnant or lactating females, males or females of childbearing potential not willing to use contraception throughout the study.
- •The subject has any other factors that may affect the efficacy or safety evaluation of this study, and is not suitable for participation in this study in the opinion of the investigator.
研究组 & 干预措施
HDM1005 Cohort 1
Experimental
干预措施: HDM1005 1 (Drug)
HDM1005 Cohort 2
Experimental
干预措施: HDM1005 2 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
primary outcome
时间窗: week 40
The percentage change in body weight from baseline to week 40
Co-primary outcome
时间窗: week 40
Proportion of subjects with body weight reduction ≥ 5% at Week 40.
次要结局
- secondary outcome(week 52)
- safety outcome(week 52)
- patient report outcome(week 52)
- Immunogenicity outcome(week 52)
研究者
研究点 (1)
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