NCT07262762已完成不适用
A Post-marketing Real-world Study for Evaluating Effectiveness and Safety of Spartina® (Tirzepatide Manufactured by CinnaGen) in Patients With Obesity and Overweight
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cinnagen
- 入组人数
- 175
- 试验地点
- 25
- 主要终点
- Proportion of patients with ≥5% weight loss
研究概览
简要总结
The goal of this study is to evaluate Effectiveness and safety of Spartina® (Tirzepatide) in male or female participants with obesity and overweight. The main questions which are aimed to be answered:
- Is Spartina® (Tirzepatide) effective in the treatment of obesity and overweight?
- Is Spartina® (Tirzepatide) safe in the treatment of obesity and overweight?
In this study, there is no comparison group. Participants receive Spartina® (Tirzepatide)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 ≥18 years of age
- •Willingness for signing and having signed the informed consent form
- •BMI ≥30 kg/m² or ≥27 kg/m² with ≥1 weight-related comorbidity
排除标准
- •Prior use of any GLP-1 agonist in the last 6 months
- •Type 1 diabetes mellitus
- •Any condition or circumstance that might pose a risk to the subject or interfere with the ability to acquire satisfactory clinical data
- •Pregnancy or breast-feeding
- •Personal or family history of medullary thyroid carcinoma (MTC) or patients with multiple endocrine neoplasia syndrome type 2 (MEN 2)
结局指标
主要结局
Proportion of patients with ≥5% weight loss
时间窗: day 0, 180
次要结局
- Proportion of patients with ≥15% weight loss(day 0, 180)
- Percent change in body weight from baseline(day 0, 90)
- Absolute change in body weight from baseline(day 0, 90)
- Assessment of immunogenicity at screening, day 90, and day 180(day 0, 90, 180)
- Percent change in body weight from baseline(day 0, 180)
- Absolute change in body weight from baseline(day 0, 180)
- Mean change in Body Mass Index from baseline(day 0, 90, 180)
- Mean change in waist circumference from baseline(day 0, 90, 180)
- Proportion of patients with ≥5% weight loss(day 0, 90)
- Proportion of patients with ≥10% weight loss(day 0, 90, 180)
- Proportion of patients with ≥15% weight loss(day 0, 180)
- Assessment of the adverse events (including Treatment Emergent Adverse Events)(during study period)
- Assessment of immunogenicity at screening(day 0, 90, 180)
研究者
研究点 (25)
Loading locations...
相似试验
尚未招募
1 期
A Study of HY001N in the Treatment of Relapsed or Refractory Neurological Autoimmune DiseasesNCT07265206Juventas Cell Therapy Ltd.15
尚未招募
2 期
SPARTANA : Spartalizumab, mDCF (docetaxel, cisplatin and 5-fluorouracil) and radiotherapy in patients with metastatic squamous cell anal carcinoma.2024-516005-23-00Centre Hospitalier Regional Universitaire34
已完成
2 期
Phase II, Open-Label Study of preliminary efficacy of Sitravatinib in Combination with Tislelizumab in Patients with Metastatic Uveal Melanoma with liver metastases.2024-519451-29-00Grupo Espanol Multidisciplinar De Melanoma16
招募中
2 期
A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLCNCT07264816Sichuan Baili Pharmaceutical Co., Ltd.80
招募中
1 期
KSV01 Injection for the Treatment of Relapsed/Refractory Diffuse Large B-Cell LymphomaDiffuse Large B Cell Lymphoma (DLBCL)NCT07260812TCRx Therapeutics Co.Ltd18