NCT07243171招募中1 期
A Multicenter, Multiple-dose Escalation, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral Ecnoglutide Tablets in Chinese Participants With Overweight or Obesity
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- The incidence and severity of adverse events
研究概览
简要总结
The aim of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of oral ecnoglutide tablets in Chinese participants with overweight or obesity
详细描述
In this study, eligible participants will be randomized to receive either oral ecnoglutide tablet or placebo once daily for up to 3 weeks (Cohort C1) or 4 weeks (Cohort C2 or C6), or once weekly for up to 24 weeks (Cohort C3, C4 and C5), including a dose escalation period.
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
- 是
入选标准
- •At the time of informed consent, with BMI in the range of 24.0 to 35.0 kg/m2 (including the threshold), body weight >60.0 kg for male, and weight >50.0 kg for female;
- •Self-declaration of body weight change <5% within 3 months prior to informed consent ;
排除标准
- •Diagnosis of overweight or obesity due to endocrine disorders , such as Cushing's syndrome;
- •Diagnosis of other endocrine disorders with clinical significance, including but not limited to hyperthyroidism or hypothyroidism, thyroid nodules (imaging shows TI-RADS≥ class 3), thyroid cancer, or personal or family history of type 2 multiple endocrine tumor syndrome (MEN2), etc.
- •Diagnosis of cardiovascular or cerebrovascular diseases with clinical significance within 6 months prior to screening, including but not limited to acute stroke, acute coronary syndrome, heart failure, arrhythmia, etc.
- •Diagnosis of severe gastrointestinal diseases, including but not limited to inflammatory bowel disease, active ulcers, irritable bowel syndrome, celiac disease, dyspepsia, diabetic gastroparesis, diabetic diarrhea, clinical gastric emptying abnormalities (such as pyloric obstruction), etc.
- •History of major gastrointestinal surgery (except cholecystectomy or appendectomy), or metabolic surgery, or plan to undergo major surgery during the study period;
- •HbA1c ≥6.5% or fasting blood glucose ≥7.0 mmol/L, or OGTT 2-hour blood glucose ≥11.1 mmol/L, at screening;
- •Clinical laboratory test results with clinical significance
研究组 & 干预措施
oral ecnoglutide dose 2
Experimental
once daily
干预措施: ecnoglutide tablets (Drug)
oral ecnoglutide dose 3
Experimental
once weekly
干预措施: ecnoglutide tablets (Drug)
placebo dose 1
Placebo Comparator
once daily
干预措施: placebo with matching dosage (Drug)
placebo dose 2
Placebo Comparator
once weekly
干预措施: placebo with matching dosage (Drug)
oral ecnoglutide dose 1
Experimental
once daily
干预措施: ecnoglutide tablets (Drug)
oral ecnoglutide dose 4
Experimental
once weekly
干预措施: ecnoglutide tablets (Drug)
结局指标
主要结局
The incidence and severity of adverse events
时间窗: up to day 204
次要结局
- Pharmacokinetics of oral ecnoglutide tablet(up to day 204)
- Change of hip circumference from baseline(up to day 204)
- Change of body weight from baseline(up to day 204)
- Change of neck circumference from baseline(up to day 204)
- Change of BMI from baseline(up to day 204)
- Change of fasting blood glucose from baseline(up to day 204)
- Change of fasting insulin from baseline(up to day 204)
- Change of waist circumference from baseline(up to day 204)
- Change of waist/hip ratio from baseline(up to day 204)
- Change of lipid profile from baseline(up to day 204)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
A Multiple-dose Study of Gantenerumab in Japanese Alzheimer&Apos;s Disease PatientsAlzheimer's DiseaseNCT01656525Chugai Pharmaceutical28
招募中
1 期
A Study on the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of CAN106 in Subjects With PNHPNHHemolysisNCT05539248CARE Pharma Shanghai Ltd.78
已完成
1 期
Study of TAK-733 in Adult Patients With Advanced Nonhematologic MalignanciesAdvanced Non-hematologic MalignanciesAdvanced Metastatic MelanomaNCT00948467Millennium Pharmaceuticals, Inc.51
已完成
1 期
A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).Peripheral Arterial Disease (PAD)NCT00760565Hoffmann-La Roche72
已完成
1 期
Study to Evaluate Multiple Doses of ERB-041 in Healthy, Female Japanese SubjectsHealthyNCT00434187Wyeth is now a wholly owned subsidiary of Pfizer24