Effect and Safety of Benaglutide or Metformin in Patients With Simple Obesity Who Have Inadequate Weight Control :A Randomized, Open, Controlled and Single-site Clinical Trail
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in body weight
研究概览
简要总结
This is a randomized, open, controlled and single-site clinical trail to investigate the effect and safety of Benaglutide or Metformin in patients with simple obesity who have inadequate weight control.
详细描述
This is a randomized, open, controlled and single-site clinical trail to investigate the effect and safety of Benaglutide or Metformin in patients with simple obesity who have inadequate weight control.
Screening will be made to select eligible participants before intervention. Patients were randomly assigned to one of two groups(metformin or benaglutide) for therapies for 12 weeks including a two-week dose adjustment period and a 10-week dose stabilization period. Lifestyle interventions will be maintained during the treatment period. Subjects are followed up every 4 weeks for examinations.At the end of the study, data will be collected and analyzed.
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
- None
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1)20 years old≤70 years old; (2) simple obesity, gender is not limited; (3) 28.0≤BMI≤37.5kg/m2; (4) Before the screening period, the body weight was controlled by lifestyle interventions (diet and exercise) for at least 3 months, and weight was decreased by <5% from baseline; (5) Agree to sign the informed consent form;
排除标准
- •Accurately diagnosed as having type 1 or type 2 diabetes according to the WHO 1999 diagnostic criteria;
- •Use weight loss drugs within 3 months before screening;
- •Metformin was used within the first 3 months of screening;
- •Malignant tumors (excluding basal cell or squamous cell carcinoma treated) within 5 years before enrollment
- •Alanine aminotransferase or aspartate aminotransferase > 3 times the upper limit of normal or total serum bilirubin (TB) >34.2 μmol/L (>2 mg/dL)
- •Patients with moderate/severe renal impairment or end-stage renal disease (eGFR < 60 mL/min/1.73 m2); male subjects with serum creatinine (Cr) ≥133 μmol/L (≥1.50 mg/dL Serum Cr in female subjects was ≥124 μmol/L (>1.40 mg/dL);
- •Severe heart, lung, nervous, mental and infectious diseases;
- •Pregnancy, lactation and recent pregnancy plans;
- •Alternate or chronic systemic corticosteroid therapy, defined as treatment with any dose of systemic corticosteroids within 3 months of enrollment visit V1 > 4 weeks
- •History of alcohol abuse, history of abuse of active drugs (opioids, analgesics, etc.) within 6 months before enrollment;
- •Give any other test drug within 30 days before enrollment or within 5 half-lives of other test drugs;
- •Patients with past history or family history of medullitary thyroid cancer (MTC) and patients with type 2 multiple endocrine tumor syndrome (MEN2);
- •Inability to tolerate benalutide, metformin;
- •Any influence of the investigator's judgment on enrollment.
研究组 & 干预措施
Metformin
Metformin Hydrochloride Tablet 500mg po by month,three times a day for 12 weeks
干预措施: Metformin (Drug)
Benaglutide
Benaglutide Injection 0.2mg, iH,po, three times a day for 3 12 weeks
干预措施: Benaglutide (Drug)
结局指标
主要结局
Changes in body weight
时间窗: Change from Baseline after 12 weeks treatment
Changes in body weight from baseline were observed in patients with simple obesity after 12 weeks of treatment intervention.
次要结局
- Changes in body mass index (BMI) of subjects(Change from Baseline after 12 weeks treatment)
- Changes in blood lipid levels(Change from Baseline after 12 weeks treatment)
- Changes in Body Fat Levels(Change from Baseline after 12 weeks treatment)
研究者
Dalong Zhu
Chief Physician
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School