Status:
UNKNOWN
The Effect of SHR20004（Noiiglutide ） on Body Weight in Obese Subjects Without Diabetes
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
Obesity
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The study is being conducted to assess the efficacy and safety of SHR20004 on body weight in obese subjects without diabetes.
Eligibility Criteria
Inclusion
- Informed consent obtained prior to any trial-related activities
- Body mass index (BMI) between 28 and 40 kg/m2(both inclusive)
- Diet and exercise management for at least 3 months before screening and less than 5% change in body weight during the previous 3 months（self-reported）.
Exclusion
- History of endocrine disease or treatment that may significantly affect body weight prior to screening visit
- History of diabetes
- Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2)
- History of pancreatitis
- Previous surgical treatment of obesity
- Screening calcitonin of 20 ng/L or above
Key Trial Info
Start Date :
March 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2022
Estimated Enrollment :
254 Patients enrolled
Trial Details
Trial ID
NCT04799327
Start Date
March 29 2021
End Date
May 15 2022
Last Update
March 15 2022
Active Locations (2)
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1
Chinese PLA General Hospital
Beijing, Beijing Municipality, China, 100853
2
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, China, 030000