Clinical trial NCT04799327: The Effect of SHR20004（Noiiglutide ） on Body Weight in Obese Subjects Without Diabetes
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-16
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assign to SHR20004 or placebo
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Change from baseline in body weight
timeFrame: Week 0, Week 24
Secondary outcomes:
measure: Relative change from baseline in body weight(%)
timeFrame: Week 0, Week 24
measure: Proportion of subjects with body weight reduction greater than or equal to 5% and10% from baseline
timeFrame: Week 0, Week 24
measure: Change from baseline in fasting plasma glucose
timeFrame: Week 0, Week 24
measure: Change from baseline in fasting insulin
timeFrame: Week 0, Week 24
measure: Change from baseline in fasting C-peptide
timeFrame: Week 0, Week 24
measure: Change from baseline in fasting blood lipids
timeFrame: Week 0, Week 24
measure: Change from baseline in glycosylated hemoglobin
timeFrame: Week 0, Week 24
measure: Change from baseline in blood pressure
timeFrame: Week 0, Week 24
measure: Change from baseline in waist circumference
timeFrame: Week 0, Week 24
measure: Change from baseline in waist-to-hip ratio
timeFrame: Week 0, Week 24
measure: Change from baseline in BMI
timeFrame: Week 0, Week 24
measure: Change from baseline in plasma glucose of 120 minutes after oral glucose tolerance test （OGTT）
timeFrame: Week 0, Week 24
measure: Change from baseline in insulin of 120 minutes after oral glucose tolerance test （OGTT）
timeFrame: Week 0, Week 24
measure: Change from baseline in C-peptide of 120 minutes after oral glucose tolerance test （OGTT）
timeFrame: Week 0, Week 24
measure: Change from baseline in AUC0-2h of plasma glucose during OGTT
timeFrame: Week 0, Week 24
measure: Change from baseline in AUC0-2h of insulin during OGTT
timeFrame: Week 0, Week 24
measure: Change from baseline in AUC0-2h of C peptide during OGTT
timeFrame: Week 0, Week 24
measure: Percentage of subjects developing anti-drug antibody of SHR20004
timeFrame: Week 0-25
measure: Percentage of subjects with an Adverse events
timeFrame: Week 0-25
measure: Percentage of subjects with Injection site reactions
timeFrame: Week 0-25
measure: 12-lead ECG
timeFrame: Week 0-25
measure: Concentration of SHR20004 in plasma at steady state
timeFrame: Week 8
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: TaiYuan
country: China
facility: Shanxi Provincial People's Hospital
state: Shanxi
Study officials:
References: