NCT04799327UnknownPhase 2
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.
Jiangsu HengRui Medicine Co., Ltd.2 sites in 1 country254 target enrollmentStarted: March 29, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Enrollment
- 254
- Locations
- 2
- Primary Endpoint
- Change from baseline in body weight
Study Overview
Brief Summary
The study is being conducted to assess the efficacy and safety of SHR20004 on body weight in obese subjects without diabetes.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Treatment group A
Experimental
Intervention: SHR20004 (Drug)
Treatment group B
Experimental
Intervention: SHR20004 (Drug)
Treatment group C
Experimental
Intervention: SHR20004 (Drug)
Treatment group D
Placebo Comparator
Intervention: placebo (Drug)
Outcomes
Primary Outcomes
Change from baseline in body weight
Time Frame: Week 0, Week 24
Change from baseline in body weight in kilograms
Secondary Outcomes
- Change from baseline in glycosylated hemoglobin(Week 0, Week 24)
- Change from baseline in insulin of 120 minutes after oral glucose tolerance test （OGTT）(Week 0, Week 24)
- Change from baseline in C-peptide of 120 minutes after oral glucose tolerance test （OGTT）(Week 0, Week 24)
- Change from baseline in AUC0-2h of plasma glucose during OGTT(Week 0, Week 24)
- Change from baseline in AUC0-2h of insulin during OGTT(Week 0, Week 24)
- Change from baseline in AUC0-2h of C peptide during OGTT(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(Week 0-25)
- Concentration of SHR20004 in plasma at steady state(Week 8)
- Relative change from baseline in body weight(%)(Week 0, Week 24)
- Change from baseline in fasting plasma glucose(Week 0, Week 24)
- 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 C-peptide(Week 0, Week 24)
- Change from baseline in fasting blood lipids(Week 0, Week 24)
- Change from baseline in blood pressure(Week 0, Week 24)
- Change from baseline in waist circumference(Week 0, Week 24)
- Change from baseline in fasting insulin(Week 0, Week 24)
- Change from baseline in waist-to-hip ratio(Week 0, Week 24)
- Change from baseline in BMI(Week 0, Week 24)
- Change from baseline in plasma glucose of 120 minutes after oral glucose tolerance test （OGTT）(Week 0, Week 24)
Investigators
Study Sites (2)
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