A Study of Supaglutide in Chinese Type 2 Diabetes Patients
A Randomized, Double-Blind, Placebo-controlled Study of Supaglutide on the Safety, Pharmacokinetics and Pharmacodynamics, and Efficacy in Chinese Patients With Type 2 Diabetes.
Asset
Efsubaglutide Alfa
Subcutaneous · GLP-1 agonist
Listed sites
1
Recruiting sites
-
Actual enrollment
40
Study population
Type 2 diabetes
Eligibility highlights
•BMI 20-40•HbA1c 7-10%
Primary endpoints
•HbA1c•Adverse Events•Vital Sign
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. Have diagnosed with type 2 diabetes for at least 3 months before enrollment.
2. Have diet and exercise intervention only (for part A and part B) or been treated with stable dose of metformin as monotherapy for at least 3 months (for part B only)
3. Have HbA1c ≥7.0% and ≤10.0% as assessed by the central laboratory.
4. Have a body mass index (BMI) of 20-40 kilograms per square meter (kg/m^2).
Exclusion criteria
1. Type 1 diabetes (T1D).
2. Evidences of fasting C-peptide levels<0.81 ng/mL.
3. History of trauma, infection or surgery within a month;
4. History of blood donation, blood transfusion or losing more than 450 ml blood within 3 months.
5. History of the severe cardiovascular conditions, gastrointestinal diseases, blood system diseases, pancreatitis, or malignant tumors.
6. Evidence of abnormal thyroid function within 6 months before screening.
7. Positive test results in HBsAg, HCVAB, HIVAB or TPAB.
8. History of serious mental illness.
9. History of drug or alcohol abuse.
10. History of a transplanted organ, acquired or congenital immune system diseases.
11. Allergy to active ingredients or excipients of the test drug.
12. Evidence of abnormal result of laboratory examination according to the judgment of researchers.
13. Participated in any interventional medical, surgical, or pharmaceutical study within 3 months prior to entry into the study.
14. Previously completed or withdrawn from this study after providing informed consent.
Endpoints (16)
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
1 endpointBody Weight
Time frame:Baseline, 7 weeks, 17weeks
descriptive
Glycemic / diabetes
5 endpointsHbA1c
Time frame:Baseline, 7 weeks, 17weeks
descriptive
HbA1c <7%
Time frame:Baseline, 7 weeks, 17weeks
descriptive
Fasting Blood Glucose
Time frame:Baseline, 7 weeks, 17weeks
descriptive
Fasting Blood Insulin
Time frame:Baseline, 7 weeks, 17weeks
descriptive
Fasting Blood C-peptide
Time frame:Baseline, 7 weeks, 17weeks
descriptive
Cardiometabolic biomarkers
1 endpointBlood Lipid
Time frame:Baseline, 7 weeks, 17weeks
descriptive
Safety / tolerability / PK
7 endpointsAdverse Events
Time frame:Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
descriptive
Vital Sign
Time frame:Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
descriptive
Laboratory Tests
Time frame:Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
descriptive
Immunogenicity Tests
Time frame:Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
descriptive
Pharmacokinetics (PK): Area Under the Curve
Time frame:Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)
descriptive
Pharmacokinetics (PK): t½ of Supaglutide
Time frame:Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168 and 336 hours post dose (in part A)
descriptive
PK: Tmax of Supaglutide
Time frame:Day1, Day8, Day36 and Day43: Predose, 3, 6, 12, 24, 48, 72, 96, 168, and 336 hours post dose (in part A)
concentration, descriptive
Other (unclassified)
2 endpoints12-lead ECGs
Time frame:Baseline , through 12 weeks for part A; Baseline, through 17 weeks for part B
descriptive
Glycosylated Albumin
Time frame:Baseline, 7 weeks, 17weeks
descriptive
Publications (1)
Bibliography
Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.
Registry references + supporting bibliography
- PMID39961992via clinicaltrials gov reference derived
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 November 5, 2026 snapshot.