NCT06565871尚未招募2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Obese Subjects With Obstructive Sleep Apnea (OSA)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 108
- 主要终点
- Percentage change from baseline in body weight
研究概览
简要总结
The purpose of this study is to evaluate the effect and safety of HRS9531 Injection in Obese Subjects with Obstructive Sleep Apnea
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
- •Male or female subjects, age 18-65(both inclusive) at the time of signing informed consent.
- •At screening visit, BMI 24-42kg/m2(both inclusive)
- •Self-reported Diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months.
- •At screening visit, AHI ≥15 and Obstructive Sleep Apnea on PSG
排除标准
- •Endocrine disorders that may significantly affect body weight, or obesity or hereditary obesity syndrome due to a single gene mutation;
- •Diabetes (except gestational diabetes)
- •There are diseases that may require systemic glucocorticoid therapy during the study period
- •Any previous or planned surgery for sleep apnea or major ear, nose or throat surgery, including tonsillectomy and adenoidectomy that still may affect breathing at time of screening Visit .Inclusion of a participant with more minor ear, nose or throat surgery (for example, deviated septum) will be at the investigator's discretion.
- •Previous or known history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomatosis type 2 (MEN2)
- •In or suspected of depression, bipolar disorder, suicidal tendencies, schizophrenia or other more serious mental illness;
- •Use of drugs or treatments that may lead to significant weight gain or loss within 3 months, use of stimulants and hypnotics, mirtazapine, opioids, trazodone within 3 months;
- •Patients with a history of blood donation or blood loss ≥400 ml within 3 months prior to screening, or receiving blood transfusions within 3 months
- •During the screening or before randomization ,laboratory examination meets the following conditions:
- •Fasting blood glucose ≥7.0 mmol/L, or HbA1c ≥6.5%; Hemoglobin <100 g/L; Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3× upper limit of normal range (ULN), total bilirubin (TBIL) ≥2.0×ULN; Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 (calculated based on serum creatinine using CKD-EPI formula); Fasting triglyceride (TG) >5.64 mmol/L (500 mg/dl); calcitonin ≥50 ng/L; Blood amylase or lipase ≥3×ULN; Thyroid stimulating hormone (TSH) <0.4 or >6.0 mIU/L; Abnormalities in other laboratory tests that the investigator determines may affect the assessment of efficacy or safety;
- •10、The 12-lead electrocardiogram (ECG) examination revealed clinically significant abnormalities that the investigators determined may affect the safety of the subject and QTcF>450 ms; 11、Poor blood pressure control: systolic blood pressure ≥160 mmHg, or diastolic blood pressure ≥110 mmHg, or diastolic blood pressure ≥100mmHg and deemed unsuitable for study by investigator; 12、Clinically relevant medical behavior or psychiatric disorder (other than OSA), that is associated with insomnia or excessive sleepiness in the past and at the time of screening; 13、Severe infection, severe trauma, or major or large surgery within 1 month prior to screening 14、Malignancy of any organ system within 5 years, regardless of evidence of local recurrence or metastasis; 15、A known or suspected history of alcohol and/or drug abuse; 16、The presence of a serious hematological disorder; 17、Surgery is planned during the trial (except for minor surgery that the investigators believe will not affect the trial) 18、Mentally incapacitated or speech-impaired subjects are unable to fully understand or participate in the test process; 19、In the investigator's judgment, there are circumstances (medical, psychological, social, or geographical factors, etc.) that affect subject safety or any other conditions that interfere with the evaluation of test results.
研究组 & 干预措施
HRS9531 Injection low dose
Experimental
干预措施: HRS9531 Injection (Drug)
HRS9531 Injection high dose
Experimental
干预措施: HRS9531 Injection (Drug)
Placebo
Placebo Comparator
干预措施: Placebo Injection (Drug)
结局指标
主要结局
Percentage change from baseline in body weight
时间窗: Baseline,32week
次要结局
- Proportion of subjects with weight loss of ≥10% from baseline after 32 weeks of treatment(Week 32)
- Change from Baseline in BMI(Baseline,32week)
- Change from Baseline in Apnea-Hypopnea Index (AHI)(Baseline,32week)
- Proportion of subjects with weight loss of ≥5% from baseline after 32 weeks of treatment(Week 32)
- Proportion of subjects with weight loss of ≥15%from baseline after 32 weeks of treatment(Week 32)
- Change from Baseline in Body weight(Baseline,32week)
- Percentage change from baseline in AHI(Baseline,32week)
研究者
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