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.
1 other identifier
interventional
254
1 country
2
Brief Summary
The study is being conducted to assess the efficacy and safety of SHR20004 on body weight in obese subjects without diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Mar 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 4, 2021
CompletedFirst Posted
Study publicly available on registry
March 16, 2021
CompletedStudy Start
First participant enrolled
March 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2022
CompletedMarch 15, 2022
March 1, 2021
1.1 years
March 4, 2021
March 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Change from baseline in body weight
Change from baseline in body weight in kilograms
Week 0, Week 24
Secondary Outcomes (22)
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
Week 0, Week 24
Change from baseline in fasting plasma glucose
Week 0, Week 24
Change from baseline in fasting insulin
Week 0, Week 24
Change from baseline in fasting C-peptide
Week 0, Week 24
- +17 more secondary outcomes
Study Arms (4)
Treatment group A
EXPERIMENTALTreatment group B
EXPERIMENTALTreatment group C
EXPERIMENTALTreatment group D
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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）.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Shanxi Provincial People's Hospital
Taiyuan, Shanxi, 030000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2021
First Posted
March 16, 2021
Study Start
March 29, 2021
Primary Completion
May 15, 2022
Study Completion
May 15, 2022
Last Updated
March 15, 2022
Record last verified: 2021-03