NCT06520540尚未招募1 期
A Randomized, Double-blind, Placebo-controlled Phase I Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Multiple Oral Administration of HDM1002 Tablets in Chinese Overweight and Obese Adult Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- TEAEs, SAEs, AEs leading to withdrawal, and AEs leading to death, AEs of special interest
研究概览
简要总结
• To assess the safety of multiple oral doses of HDM1002 tablets under different titrations in Chinese overweight and obese adult subjects.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese subjects aged 18 to 60 years (including 18 years and 60 years old), either male or female subjects;
- •BMI at 24.0 to 36.0 kg at screening and at random / m2Between (including 24.0 and 36.0 kg / m2）；
- •For fertile subjects, female subjects from 14 days before the informed consent form (ICF) to 30 days after the last administration, male subjects within 90 days after the ICF to the last administration, without birth planning and agreed to highly effective contraception (see Section 5.2.3 for details);
- •Ability to understand the procedures and methods of this study, voluntarily sign the ICF, and be willing to strictly comply with the clinical trial protocol requirements to complete the relevant process.
排除标准
- •Selection criteria:
- •Subjects must meet all of the following inclusion criteria to be enrolled in this study:
- •Chinese subjects aged 18 to 60 years (including 18 years and 60 years old), either male or female subjects;
- •BMI at 24.0 to 36.0 kg at screening and at random / m2Between (including 24.0 and 36.0 kg / m2）；
- •For fertile subjects, female subjects from 14 days before the informed consent form (ICF) to 30 days after the last administration, male subjects within 90 days after the ICF to the last administration, without birth planning and agreed to highly effective contraception (see Section 5.2.3 for details);
- •Ability to understand the procedures and methods of this study, voluntarily sign the ICF, and be willing to strictly comply with the clinical trial protocol requirements to complete the relevant process.
- •Exclusion criteria:
- •Subjects meeting either of the following criteria will be excluded:
- •5% self-reported or documented body weight change within 3 months prior to randomization;
- •Previous diagnosis of type 1, type 2 or any other type of diabetes; or using hypoglycemic drugs; or HbA1c 6.5% at screening or fasting glucose 7.0 mmol/L; or fasting glucose <3.9 mmol / L;
- •Diagnosis of overweight or obesity caused by other diseases or drugs;
- •History or family history of medullary thyroid carcinoma, thyroid C cell hyperplasia, or multiple endocrine adenomatosis type 2;
- •History of chronic pancreatitis or onset of acute pancreatitis within 3 months before signing an ICF;
- •History of acute gallbladder disease within 3 months before signing the ICF;
- •Any malignant tumor within 5 years before signing the ICF (except for basal cell carcinoma that has received curative treatment and is considered cured);
- •Combination of cardiovascular and cerebrovascular diseases with obvious clinical significance, including but not limited to angina pectoris, MI, stroke or severe peripheral artery circulation disorder within 1 year before signing ICF; presence of risk factors of torsade ventricular tachycardia; presence of untreated serious arrhythmia, such as sick sinus syndrome, second or third degree atrioventricular block; or screening systolic blood pressure 160 mmHg, or diastolic blood pressure 100 mmHg;
- •In the judgment of the investigator, the subjects had some diseases or conditions that may affect drug absorption, such as active inflammatory bowel disease, gastrectomy resection, any intestinal area resection, etc.;
- •Those who had major surgery within 3 months prior to signing the ICF or who performed surgery during the planned study;
- •According to the investigator, the presence of concomitant diseases, including but not limited to the respiratory system, digestive system, nervous system, urogenital system, blood system, endocrine system and other diseases;
- •Known intolerance or hypersensitivity to a GLP-1 receptor (GLP-1R) agonist;
- •Within 3 months prior to ICF signing, the following drugs were used and significantly weight, including but not limited to: a. Drugs or products with weight loss effects, such as GLP-1R agonists (liraglutide, selmeaglutide, benallutide, etc.), orlistat, naltrexone / bupropion, etc.; b. Drugs or products that increase body weight, such as systemic corticosteroids, psychiatric medication (e. g., tricyclic antidepressants, paroxetine, olanzapine, clozapine, mirtazapine, valproic acid and its derivatives, etc.); c. Any Chinese patent medicine or Chinese herbal medicine that may affect the body weight;
- •Any drug used within 14 days or may affect the pharmacokinetics of HDM1002 tablets (whichever is older) (see Section 6.4.2 and Section 6.4.3), including prescription drugs, over-the-counter drugs, Chinese herbal medicines, proprietary Chinese medicines, or nutritional supplements;
- •Subjects taking lipid-lowering drugs within 30 days before signing ICF;
- •Have participated in any clinical trial within 30 days before randomization or within 5 half-lives after the last dose (whichever is older) (except for signed ICF with no drug or device intervention);
- •Any of the laboratory indicators during the screening period met the following criteria:
- •<110 g / L for women and <120 g / L for men;
- •glutamate aminotransferase> 2.0 upper limit of normal (ULN), or aminotransferase> 2.0 ULN, or alkaline phosphatase> 1.5 x ULN, or total bilirubin> 1.5 ULN (subjects with Gil bert's syndrome can participate in this study with direct bilirubin ULN);
- •Triglycerides> 5.6 mmol / L;
- •Calcitonin: 35 ng/L;
- •Thyroid-stimulating hormone> 6.0 mIU / L or <0.4 mIU / L;
- •Blood amylase or lipase> ULN;
- •Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m, calculated from the Cooperative Epidemiological Study of Chronic Kidney Disease (CKD-EPI) formula2；
- •The following ECG abnormalities were present during the screening period: QTcF> 450 ms, or heart rate <50 beats / min or> 100 beats / min;
- •Positive test results for hepatitis B virus surface antigen, hepatitis C virus antibody or treponema pallidum antibody, or non-negative for human immunodeficiency virus;
- •More than 5 cigarettes per day in the 3 months before signing the ICF;
- •Those who had drunk alcohol abuse within 1 year before signing the ICF (i. e., drinking more than 14 standard units per week for men, women drinking more than 7 standard units per week, 1 standard unit containing 14 g alcohol, such as 360 ml beer or 150 ml alcohol of 40 ml), or prerandomized alcohol breath test or blood alcohol test positive;
- •History of addictive drug abuse within 1 year before signing the ICF, or positive urine drug test before randomization;
- •Within 7 days prior to randomization, subjects reported having consumed grapefruit or products containing grapefruit;
- •Pregnancy (blood human chorionic gonadotropin 5 mIU / ml or positive urine pregnancy test) or lactating women;
- •The subject is the investigator or other relevant investigator of the project;
- •In the opinion of the investigator, the subject was not fit to participate in any other condition of the trial.
研究组 & 干预措施
HDM1002 100 mg
Active Comparator
干预措施: HDM1002 100 mg QD 12weeks (Drug)
HDM1002 100 mg
Active Comparator
干预措施: HDM1002 200 mg QD 12weeks (Drug)
HDM1002 100 mg
Active Comparator
干预措施: HDM1002 400 mg QD 12weeks，Q 2W for titration (Drug)
HDM1002 100 mg
Active Comparator
干预措施: HDM1002 400 mg QD 12weeks，Q 3W for titration (Drug)
HDM1002 200 mg
Active Comparator
干预措施: HDM1002 200 mg QD 12weeks (Drug)
HDM1002 200 mg
Active Comparator
干预措施: HDM1002 400 mg QD 12weeks，Q 2W for titration (Drug)
HDM1002 200 mg
Active Comparator
干预措施: HDM1002 400 mg QD 12weeks，Q 3W for titration (Drug)
HDM1002 400 mg
Active Comparator
干预措施: HDM1002 400 mg QD 12weeks，Q 2W for titration (Drug)
HDM1002 400 mg
Active Comparator
干预措施: HDM1002 400 mg QD 12weeks，Q 3W for titration (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Device)
结局指标
主要结局
TEAEs, SAEs, AEs leading to withdrawal, and AEs leading to death, AEs of special interest
时间窗: Baseline, Week 12
TEAEs and SAEs (incidence, severity and causal relationship), AEs leading to withdrawal, and AEs leading to death, AEs of special interest
次要结局
- change in body weight from baseline at Day 85(Baseline, Week 12)
- change in BMI from baseline at Day 85(Baseline, Week 12)
- change in waist circumference from baseline at Day 85(Baseline, Week 12)
- Plasma PK parameters(Baseline, Week 12)
研究者
研究点 (1)
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