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

• Sponsor: Jiangsu HengRui Medicine Co., Ltd. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04799327
• Collaborator: (none)
• Enrollment: 254
• Locations: 2
• Arms: 4
• Anticipated Duration (Months): 13.5
• Patients Per Site: 127
• Patients Per Site Per Month: 9.4

Study Details

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: SHR20004; Drug: SHR20004; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 254 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Parallel Assign to SHR20004 or placeboParallel 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: Mar 29, 2021
• Anticipated Primary Completion Date: May 15, 2022
• Anticipated 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 [Week 0, Week 24]

   Change from baseline in body weight in kilograms

Secondary Outcome Measures

1. Relative change from baseline in body weight(%) [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 [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 [Week 0, Week 24]

   Change from baseline in fasting plasma glucose in mmol/L

4. Change from baseline in fasting insulin [Week 0, Week 24]

   Change from baseline in fasting insulin in μU/ml

5. Change from baseline in fasting C-peptide [Week 0, Week 24]

   Change from baseline in fasting C-peptide in ng/ml

6. Change from baseline in fasting blood lipids [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 [Week 0, Week 24]

   Change from baseline in glycosylated hemoglobin(%)

8. Change from baseline in blood pressure [Week 0, Week 24]

   Change from baseline in blood pressure in mmHg

9. Change from baseline in waist circumference [Week 0, Week 24]

   Change from baseline in waist circumference in cm

10. Change from baseline in waist-to-hip ratio [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 [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） [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） [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） [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 [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 [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 [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 [Week 0-25]

19. Percentage of subjects with an Adverse events [Week 0-25]

20. Percentage of subjects with Injection site reactions [Week 0-25]

21. 12-lead ECG [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 [Week 8]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

	Site	City	State	Country	Postal Code
1	Chinese PLA General Hospital	Beijing	Beijing	China	100853
2	Shanxi Provincial People's Hospital	TaiYuan	Shanxi	China	030000

Sponsors and Collaborators

• Jiangsu HengRui Medicine Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04799327
• Other Study ID Numbers: SHR20004-202
• First Posted: Mar 16, 2021
• Last Update Posted: Mar 15, 2022
• Last Verified: Mar 1, 2021

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

Study Results

No Results Posted as of Mar 15, 2022