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

Phase 2

• Conditions: Obesity
• Interventions: Drug: SHR20004; Drug: placebo

• Registration Number: NCT04799327
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2021-03
• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-15
• Study First Posted: 2021-03-16
• Study Start: 2021-03-29
• Last Update Submitted: 2022-03-14
• Last Update Posted: 2022-03-15
• Primary Completion: 2022-05-15
• Study Completion: 2022-05-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 254

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）.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group A	SHR20004	-
Treatment group B	SHR20004	-
Treatment group C	SHR20004	-
Treatment group D	placebo	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in body weight	Week 0, Week 24	Change from baseline in body weight in kilograms

Secondary Outcome Measures

Name	Time	Method
Change from baseline in fasting plasma glucose	Week 0, Week 24	Change from baseline in fasting plasma glucose in mmol/L
Relative change from baseline in body weight(%)	Week 0, Week 24	Relative change from baseline in body weight(%)
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
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
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
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
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
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	Week 0-25	12-lead ECG in heart rate（beats）, PR interval（ms）, QT interval(ms), QTC interval(ms), and overall conclusion description
Concentration of SHR20004 in plasma at steady state	Week 8
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
Change from baseline in fasting C-peptide	Week 0, Week 24	Change from baseline in fasting C-peptide in ng/ml
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
Change from baseline in glycosylated hemoglobin	Week 0, Week 24	Change from baseline in glycosylated hemoglobin(%)
Change from baseline in blood pressure	Week 0, Week 24	Change from baseline in blood pressure in mmHg
Change from baseline in waist circumference	Week 0, Week 24	Change from baseline in waist circumference in cm
Change from baseline in fasting insulin	Week 0, Week 24	Change from baseline in fasting insulin in μU/ml
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)
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)
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

Trial Locations

Locations (2)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China

Shanxi Provincial People's Hospital; 🇨🇳 TaiYuan, Shanxi, China