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Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus
A Phase 2, Multicenter, Randomised, Paralleled, Placebo-controlled (Double-blind) and Active Drug-controlled (Open) Study to Investigate Efficacy and Safety of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus
Lead sponsor
Assets
Dulaglutide / HEC88473
Listed sites
2
Recruiting sites
—
Enrollment
234
actual
Study population
Type 2 diabetes
Key I/E criterion
•HbA1c 7.5-10.5%
Primary endpoint
•HbA1c, change
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. Male or female patients 18 to 75 years of age, inclusive.
2. Have T2DM for at least 3 months before screening based on the disease diagnostic criteria (WHO 1999).
3. Have an HbA1c value of ≥7.5% and ≤10.5%, fasting blood-glucose ≤13.9 mmoL/L, at screening and visit 3.
Exclusion criteria
1. Have type 1 diabetes mellitus.
2. Have had ≥1 episode of severe hypoglycemia within 6 months before screening, or history of recurrent hypoglycemia (history of hypoglycemia more than 3 times in 3 months).
3. Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine aminotransferase (ALT) level >2.5 times the upper limit of the reference range at screening.
4. Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2) at screening.
5. Have serum calcitonin ≥20 ng/L at screening.
6. Fasted triglycerides > 5.7 mmol/L at screening.
Endpoints (4)
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 endpointChange from baseline of weight at week 12
Time frame:Baseline to week 12
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
2 endpointsChange from baseline of HbA1c at week 12
Time frame:Baseline to week 12
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change from baseline of fasting blood-glucose at week 12
Time frame:Baseline to week 12
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Safety / tolerability / PK
1 endpointFrequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame:Baseline to week 15
Serious AEs (any)
descriptive, event
componentsTreatment-emergent AEs (any), Serious AEs (any)
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.