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

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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Obesity
• Intervention / Treatment: Drug: placebo; Drug: SHR20004; Drug: SHR20004; Drug: SHR20004

• Study Type: Interventional
• Enrollment (Actual): 254
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Chinese PLA General Hospital
  • Shanxi
    • TaiYuan, Shanxi, China, 030000
      • Shanxi Provincial People's Hospital

Participation Criteria

Eligibility Criteria

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

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Anticipated): May 15, 2022
• Study Completion (Anticipated): May 15, 2022

Study Registration Dates

• First Submitted: March 4, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (Actual): March 16, 2021

Study Record Updates

• Last Update Posted (Actual): March 15, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SHR20004-202

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No