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

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

Official Title
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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.

Conditions
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Obesity

Intervention / Treatment
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* Drug: SHR20004
* Drug: SHR20004
* Drug: SHR20004
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assign to SHR20004 or placebo
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A<br> | Drug: SHR20004<br>* SHR20004：low dose<br>|
| Experimental: Treatment group B<br> | Drug: SHR20004<br>* SHR20004: medium dose<br>|
| Experimental: Treatment group C<br> | Drug: SHR20004<br>* SHR20004: high dose<br>|
| Placebo Comparator: Treatment group D<br> | Drug: placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in body weight | Change from baseline in body weight in kilograms | Week 0, Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change from baseline in body weight(%) | Relative change from baseline in body weight(%) | Week 0, Week 24 | 
| 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 | 
| Change from baseline in fasting plasma glucose | Change from baseline in fasting plasma glucose in mmol/L | Week 0, Week 24 | 
| Change from baseline in fasting insulin | Change from baseline in fasting insulin in μU/ml | Week 0, Week 24 | 
| Change from baseline in fasting C-peptide | Change from baseline in fasting C-peptide in ng/ml | Week 0, Week 24 | 
| 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 | 
| Change from baseline in glycosylated hemoglobin | Change from baseline in glycosylated hemoglobin(%) | Week 0, Week 24 | 
| Change from baseline in blood pressure | Change from baseline in blood pressure in mmHg | Week 0, Week 24 | 
| Change from baseline in waist circumference | Change from baseline in waist circumference in cm | Week 0, Week 24 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Percentage of subjects developing anti-drug antibody of SHR20004 |  | Week 0-25 | 
| Percentage of subjects with an Adverse events |  | Week 0-25 | 
| Percentage of subjects with Injection site reactions |  | Week 0-25 | 
| 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 | 
| Concentration of SHR20004 in plasma at steady state |  | Week 8 |