The Effect of SHR20004（Noiiglutide ） on Body Weight in Obese Subjects Without Diabetes

Obesity Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Placebo-controlled，Parallel-group Clinical Trial to Assess the Efficacy and Safety of Noiiglutide Injection in Obese Subjects Without Diabetes.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04799327
• Other study ID #: SHR20004-202
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 29, 2021
• Est. completion date: May 15, 2022

Study information

• Verified date: March 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study is being conducted to assess the efficacy and safety of SHR20004 on body weight in obese subjects without diabetes.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 254
• Est. completion date: May 15, 2022
• Est. primary completion date: May 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Informed consent obtained prior to any trial-related activities

2. Body mass index (BMI) between 28 and 40 kg/m2(both inclusive)

3. 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 Criteria:

1. History of endocrine disease or treatment that may significantly affect body weight prior to screening visit

2. History of diabetes

3. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2)

4. History of pancreatitis

5. Previous surgical treatment of obesity

6. Screening calcitonin of 20 ng/L or above

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• SHR20004
SHR20004:low dose
• SHR20004
SHR20004: medium dose
• SHR20004
SHR20004: high dose
• placebo
Placebo

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing
China	Shanxi Provincial People's Hospital	TaiYuan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in body weight	Change from baseline in body weight in kilograms	Week 0, Week 24
Secondary	Relative change from baseline in body weight(%)	Relative change from baseline in body weight(%)	Week 0, Week 24
Secondary	Proportion of subjects with body weight reduction greater than or equal to 5% and10% from baseline	Proportion of subjects with body weight reduction greater than or equal to 5% and10% from baseline	Week 0, Week 24
Secondary	Change from baseline in fasting plasma glucose	Change from baseline in fasting plasma glucose in mmol/L	Week 0, Week 24
Secondary	Change from baseline in fasting insulin	Change from baseline in fasting insulin in µU/ml	Week 0, Week 24
Secondary	Change from baseline in fasting C-peptide	Change from baseline in fasting C-peptide in ng/ml	Week 0, Week 24
Secondary	Change from baseline in fasting blood lipids	Change from baseline in fasting blood lipids including TC\TG\H-DLC\L-DLC in mmol/L	Week 0, Week 24
Secondary	Change from baseline in glycosylated hemoglobin	Change from baseline in glycosylated hemoglobin(%)	Week 0, Week 24
Secondary	Change from baseline in blood pressure	Change from baseline in blood pressure in mmHg	Week 0, Week 24
Secondary	Change from baseline in waist circumference	Change from baseline in waist circumference in cm	Week 0, Week 24
Secondary	Change from baseline in waist-to-hip ratio	Change from baseline waist-to-hip ratio(waist and hip will be combined to report waist-to-hip ratio)	Week 0, Week 24
Secondary	Change from baseline in BMI	Change from baseline in BMI (weight and height will be combined to report BMI in kg/m^2)	Week 0, Week 24
Secondary	Change from baseline in plasma glucose of 120 minutes after oral glucose tolerance test (OGTT)	Change from baseline in plasma glucose of 120 minutes after OGTT in mmol/L	Week 0, Week 24
Secondary	Change from baseline in insulin of 120 minutes after oral glucose tolerance test (OGTT)	Change from baseline in insulin of 120 minutes after OGTT in µU/ml	Week 0, Week 24
Secondary	Change from baseline in C-peptide of 120 minutes after oral glucose tolerance test (OGTT)	Change from baseline in C-peptide of 120 minutes after OGTT in ng/ml	Week 0, Week 24
Secondary	Change from baseline in AUC0-2h of plasma glucose during OGTT	Change from baseline in AUC0-2h of plasma glucose during OGTT in mmol*hr/L	Week 0, Week 24
Secondary	Change from baseline in AUC0-2h of insulin during OGTT	Change from baseline in AUC0-2h of insulin during OGTT in µU*hr/ml	Week 0, Week 24
Secondary	Change from baseline in AUC0-2h of C peptide during OGTT	Change from baseline in AUC0-2h of C peptide during OGTT in ng*hr/ml	Week 0, Week 24
Secondary	Percentage of subjects developing anti-drug antibody of SHR20004		Week 0-25
Secondary	Percentage of subjects with an Adverse events		Week 0-25
Secondary	Percentage of subjects with Injection site reactions		Week 0-25
Secondary	12-lead ECG	12-lead ECG in heart rate(beats), PR interval(ms), QT interval(ms), QTC interval(ms), and overall conclusion description	Week 0-25
Secondary	Concentration of SHR20004 in plasma at steady state		Week 8