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A Phase 1 Study of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects
A Phase 1, Randomised, Double-blind, Placebo-controlled, Single and Multiple Dose Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HEC88473 Injection in Healthy Subjects, Obese Subjects and T2DM Subjects
Lead sponsor
Asset
HEC88473
Subcutaneous · GLP-1 / FGF21 dual
Listed sites
1
Recruiting sites
—
Enrollment
164
actual
Study population
Healthy volunteers, Obesity / overweight, Type 2 diabetes
Key I/E criteria
•BMI ≤28•HbA1c ≤10.5%
Primary endpoints
•Frequency and severity of Adverse Events (AEs)•Cmax•AUC
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
Part A
1. Males or females, between 18 and 45 years of age, inclusive, at screening.
2. Body weight ≥ 50 kg for males and body weight ≥ 45 kg for females. 18≤body mass index (BMI)<28 kg/m2 for nonobese subjects and 28≤BMI≤45 kg/m2 for obese subjects.
Part B
1. Males or females, between 18 and 65 years of age, inclusive, at screening.
2. 24 kg/m2≤BMI≤35 kg/m2.
3. Subjects diagnosed with T2DM, newly diagnosed subjects at screening, or treated with diet and exercise alone within 3 months before screening and still have poor blood glucose control, or treated with a stable dose of metformin for ≥ 3 months before screening.
4. 7.0%≤ HbA1c ≤10.5% at screening.
Exclusion criteria
Part A
1. Smoked more than 5 cigarettes per day within 3 months before the study.
2. Immunization with a live attenuated vaccine or coronavirus vaccination within 1 month prior to screening or planned vaccination during the course of the study.
3. Positive alcohol breath test result or positive urine drug screen.
4. Blood donation (> 300 mL) or massive blood loss (> 400 mL) within 3 months before screening.
Part B
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 >5 times the upper limit of the reference range at screening.
4. Have serum calcitonin ≥20 ng/L at screening.
5. Have a personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2; or have hereditary diseases that can easily induce MTC.
6. Fasted triglycerides > 5.7 mmol/L at screening. If the patient is on lipid-lowering therapies, doses must be stable for 30 days prior to screening.
Endpoints (9)
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
Glycemic / diabetes
2 endpointsOGTT
Time frame:Day-1, Day3 and Day 7
descriptive
Change from baseline of HbA1c at day 38
Time frame:Baseline to day 38
change from baseline, improvement
Cardiometabolic biomarkers
1 endpointFasting lipid concentration
Time frame:Baseline to day 43
concentration, descriptive
Safety / tolerability / PK
5 endpointsFrequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473
Time frame:Baseline to day 15
descriptive
Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473
Time frame:Baseline to day 43
descriptive
Cmax
Time frame:Predose and postdose 4、8、10、12、14、24、48、72、96、168、216、336 hours
concentration, descriptive
AUC
Time frame:Predose and postdose 4、8、10、12、14、24、48、72、96、168、216、336 hours
concentration, descriptive
Assessment of the incidence of anti drug antibodies (ADA) developed against HEC88473 after dosing
Time frame:Baseline to day 43
event count, event
Other (unclassified)
1 endpointChange from baseline of Adiponectin at day 38
Time frame:Baseline to day 38
change from baseline, improvement
Publications (2)
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
- Journal of hepatology2025 Jun (month)PMID39709140doi:10.1016/j.jhep.2024.12.006via clinicaltrials gov reference derived + pubmed nct search
- BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy2025 May (month)PMID40175670doi:10.1007/s40259-025-00715-3via clinicaltrials gov reference derived + pubmed nct search
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.