NCT06287437进行中（未招募）2 期
A Single-center, Double-blinded, Randomized, Placebo-controlled Trial to Evaluate the Effectiveness and Safety of Low-frequency Injection of HRS9531 in Control of Weight Regain in Obese Subjects With and Without Diabetes
Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Percent Change in Body Weight from 24 weeks
研究概览
简要总结
This is a single-center, double-blinded, randomized, placebo-controlled phase II study to explore the effectiveness, safety and energy balance mechanism of low-frequency continuous subcutaneous injection of HRS9531 to inhibit weight regain in obese non-diabetic and obese diabetic patients
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
- 否
入选标准
- •30-60 years old, female and male.
- •BMI:30-40kg/m
- •Non diabetes or type 2 diabetes with HbA1c between 7-10%.
排除标准
- •Weight change ≤5 kg within 3 months.
- •Hb<110g/L.
- •Serum triglycerides 5.7 mmol/L.
- •Impaired liver function ：ALT or AST≥3×ULN，TB≥2×ULN.
- •Impaired renal function：eGFT < 45 ml/min.
- •Hemodiastase or Serum lipase≥3×ULN.
- •TSH>6.0 mIU/L or<0.4 mIU/L.
- •Systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg.
- •lth Questionnaire-9 (PHQ-9) score ≥
- •Type 1 diabetes.
- •Proliferative diabetic retinopathy, ketoacidosis or hyperglycemia hypertonic state within 3 months.
- •In the investigator's judgment, there were circumstances that affected subject safety or otherwise interfered with the evaluation of results.
研究组 & 干预措施
Intervention
Experimental
The subjects receive sequential once weekly and low frequency subcutaneous injection of HRS 9531
干预措施: HRS9531 (Drug)
Control
Placebo Comparator
The subjects receive low frequency subcutaneous injection of the placebo
干预措施: HRS9531 placebo (Drug)
结局指标
主要结局
Percent Change in Body Weight from 24 weeks
时间窗: 36 weeks
Percentage change in body weight from the low-frequency injection phase for HRS9531 compared with placebo
次要结局
- Energy intake change from 24 weeks(24-36 weeks)
- Energy expenditure change from 24 weeks(24-36 weeks)
- Metabolic adaptation from 24 weeks(24-36 weeks)
- Systolic blood pressure and diastolic blood pressure change from 24 weeks(24-36 weeks)
- Body fat rate change from 24 weeks(24-36 weeks)
- Serum total cholesterol change from 24 weeks(24-36 weeks)
- Triglyceride change from 24 weeks(24-36 weeks)
- Nonestesterified fatty acid change from 24 weeks(24-36 weeks)
- Energy intake at baseline(0 weeks)
- Energy expenditure at baseline(0 weeks)
- Appetite at baseline (assessed by Visual Analogue Scale subjective rating scale)(0 weeks)
- Percent Change in Body Weight at 24 weeks(24 weeks)
- Appetite at 24 weeks (assessed by Visual Analogue Scale subjective rating scale)(24 weeks)
- Energy expenditure at 24 weeks(24 weeks)
- Energy intake at 24 weeks(24 weeks)
研究者
Xiaoying Li
Study Principal Investigator
Shanghai Zhongshan Hospital
研究点 (1)
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