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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.
Lead sponsor
Asset
Noiiglutide / HS-20004 / SHR20004
Oral · GLP-1 agonist
Listed sites
2
Recruiting sites
—
Enrollment
254
actual
Study population
Obesity / overweight
Key I/E criterion
•BMI 28-40
Primary endpoint
•Body weight
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Endpoints (23)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
6 endpointsChange from baseline in body weight
Time frame:Week 0, Week 24
change from baseline, improvement
Relative change from baseline in body weight(%)
Time frame:Week 0, Week 24
percent change from baseline, improvement
Proportion of subjects with body weight reduction greater than or equal to 5% and10% from baseline
Time frame:Week 0, Week 24
threshold achievement, improvement
Change from baseline in waist circumference
Time frame:Week 0, Week 24
change from baseline, improvement
Change from baseline in waist-to-hip ratio
Time frame:Week 0, Week 24
change from baseline, improvement
Change from baseline in BMI
Time frame:Week 0, Week 24
change from baseline, improvement
Glycemic / diabetes
9 endpointsChange from baseline in fasting plasma glucose
Time frame:Week 0, Week 24
change from baseline, improvement
Change from baseline in fasting insulin
Time frame:Week 0, Week 24
change from baseline, improvement
Change from baseline in fasting C-peptide
Time frame:Week 0, Week 24
change from baseline, improvement
Change from baseline in plasma glucose of 120 minutes after oral glucose tolerance test （OGTT）
Time frame:Week 0, Week 24
change from baseline, improvement
Change from baseline in insulin of 120 minutes after oral glucose tolerance test （OGTT）
Time frame:Week 0, Week 24
change from baseline, improvement
Change from baseline in C-peptide of 120 minutes after oral glucose tolerance test （OGTT）
Time frame:Week 0, Week 24
change from baseline, improvement
Change from baseline in AUC0-2h of plasma glucose during OGTT
Time frame:Week 0, Week 24
change from baseline, improvement
Change from baseline in AUC0-2h of insulin during OGTT
Time frame:Week 0, Week 24
change from baseline, improvement
Change from baseline in AUC0-2h of C peptide during OGTT
Time frame:Week 0, Week 24
change from baseline, improvement
Cardiometabolic biomarkers
2 endpointsChange from baseline in fasting blood lipids
Time frame:Week 0, Week 24
change from baseline, improvement
Change from baseline in blood pressure
Time frame:Week 0, Week 24
change from baseline, improvement
Safety / tolerability / PK
4 endpointsPercentage of subjects developing anti-drug antibody of SHR20004
Time frame:Week 0-25
threshold achievement, event
Percentage of subjects with an Adverse events
Time frame:Week 0-25
threshold achievement, event
Percentage of subjects with Injection site reactions
Time frame:Week 0-25
threshold achievement, event
12-lead ECG
Time frame:Week 0-25
descriptive
Other (unclassified)
2 endpointsChange from baseline in glycosylated hemoglobin
Time frame:Week 0, Week 24
change from baseline, improvement
Concentration of SHR20004 in plasma at steady state
Time frame:Week 8
concentration, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.