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

• ClinicalTrials.gov Identifier: NCT04799327
• Recruitment Status: Enrolling by invitation
• First Posted: March 16, 2021
• Last Update Posted: October 13, 2021
• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Information provided by (Responsible Party): Jiangsu HengRui Medicine Co., Ltd.

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Obesity	Drug: SHR20004; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 252 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel Assign to SHR20004 or placebo
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: March 29, 2021
• Estimated Primary Completion Date: May 15, 2022
• Estimated Study Completion Date: May 15, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment group A	Drug: SHR20004; SHR20004：low dose
Experimental: Treatment group B	Drug: SHR20004; SHR20004: medium dose
Experimental: Treatment group C	Drug: SHR20004; SHR20004: high dose
Placebo Comparator: Treatment group D	Drug: placebo; Placebo

Outcome Measures

Primary Outcome Measures :

1. Change from baseline in body weight [ Time Frame: Week 0, Week 24 ]
   Change from baseline in body weight in kilograms

Secondary Outcome Measures :

1. Relative change from baseline in body weight(%) [ Time Frame: Week 0, Week 24 ]
   Relative change from baseline in body weight(%)
2. Proportion of subjects with body weight reduction greater than or equal to 5% and10% from baseline [ Time Frame: Week 0, Week 24 ]
   Proportion of subjects with body weight reduction greater than or equal to 5% and10% from baseline
3. Change from baseline in fasting plasma glucose [ Time Frame: Week 0, Week 24 ]
   Change from baseline in fasting plasma glucose in mmol/L
4. Change from baseline in fasting insulin [ Time Frame: Week 0, Week 24 ]
   Change from baseline in fasting insulin in μU/ml
5. Change from baseline in fasting C-peptide [ Time Frame: Week 0, Week 24 ]
   Change from baseline in fasting C-peptide in ng/ml
6. Change from baseline in fasting blood lipids [ Time Frame: Week 0, Week 24 ]
   Change from baseline in fasting blood lipids including TC\TG\H-DLC\L-DLC in mmol/L
7. Change from baseline in glycosylated hemoglobin [ Time Frame: Week 0, Week 24 ]
   Change from baseline in glycosylated hemoglobin(%)
8. Change from baseline in blood pressure [ Time Frame: Week 0, Week 24 ]
   Change from baseline in blood pressure in mmHg
9. Change from baseline in waist circumference [ Time Frame: Week 0, Week 24 ]
   Change from baseline in waist circumference in cm
10. Change from baseline in waist-to-hip ratio [ Time Frame: Week 0, Week 24 ]
    Change from baseline waist-to-hip ratio（waist and hip will be combined to report waist-to-hip ratio)
11. Change from baseline in BMI [ Time Frame: Week 0, Week 24 ]
    Change from baseline in BMI (weight and height will be combined to report BMI in kg/m^2)
12. Change from baseline in plasma glucose of 120 minutes after oral glucose tolerance test （OGTT） [ Time Frame: Week 0, Week 24 ]
    Change from baseline in plasma glucose of 120 minutes after OGTT in mmol/L
13. Change from baseline in insulin of 120 minutes after oral glucose tolerance test （OGTT） [ Time Frame: Week 0, Week 24 ]
    Change from baseline in insulin of 120 minutes after OGTT in μU/ml
14. Change from baseline in C-peptide of 120 minutes after oral glucose tolerance test （OGTT） [ Time Frame: Week 0, Week 24 ]
    Change from baseline in C-peptide of 120 minutes after OGTT in ng/ml
15. Change from baseline in AUC0-2h of plasma glucose during OGTT [ Time Frame: Week 0, Week 24 ]
    Change from baseline in AUC0-2h of plasma glucose during OGTT in mmol*hr/L
16. Change from baseline in AUC0-2h of insulin during OGTT [ Time Frame: Week 0, Week 24 ]
    Change from baseline in AUC0-2h of insulin during OGTT in μU*hr/ml
17. Change from baseline in AUC0-2h of C peptide during OGTT [ Time Frame: Week 0, Week 24 ]
    Change from baseline in AUC0-2h of C peptide during OGTT in ng*hr/ml
18. Percentage of subjects developing anti-drug antibody of SHR20004 [ Time Frame: Week 0-25 ]
19. Percentage of subjects with an Adverse events [ Time Frame: Week 0-25 ]
20. Percentage of subjects with Injection site reactions [ Time Frame: Week 0-25 ]
21. 12-lead ECG [ Time Frame: Week 0-25 ]
    12-lead ECG in heart rate（beats）, PR interval（ms）, QT interval(ms), QTC interval(ms), and overall conclusion description
22. Concentration of SHR20004 in plasma at steady state [ Time Frame: Week 8 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

China, Beijing

Chinese PLA General Hospital

Beijing, Beijing, China, 100853

China, Shanxi

Shanxi Provincial People's Hospital

TaiYuan, Shanxi, China, 030000

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

More Information

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04799327
• Other Study ID Numbers: SHR20004-202
• First Posted: March 16, 2021
• Last Update Posted: October 13, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No