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CompletedPhase 1

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

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 ≤28HbA1c ≤10.5%

Primary endpoints

Frequency and severity of Adverse Events (AEs)CmaxAUC

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

NCT IDNCT05943886
Org study IDHEC88473-DM-101

Timeline

Milestones

Study start2021-08-11actual
Primary completion2023-02-17actual
Study completion2023-02-17actual
Study first posted2023-07-13actual
Last update posted2023-07-17actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersObesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age65 Years
SexAll
Healthy volunteersAccepted

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

Safety / tolerability / PK
5
Glycemic / diabetes
2
Cardiometabolic biomarkers
1
Other (unclassified)
1

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

OGTT

Time frame:Day-1, Day3 and Day 7

descriptive

Secondary/protocol endpoint

Change from baseline of HbA1c at day 38

Time frame:Baseline to day 38

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Fasting lipid concentration

Time frame:Baseline to day 43

concentration, descriptive

Safety / tolerability / PK

5 endpoints
Primary/protocol endpoint

Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after a single dose of HEC88473

Time frame:Baseline to day 15

descriptive

Primary/protocol endpoint

Frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) after multiple dose of HEC88473

Time frame:Baseline to day 43

descriptive

Primary/protocol endpoint

Cmax

Time frame:Predose and postdose 4、8、10、12、14、24、48、72、96、168、216、336 hours

concentration, descriptive

Primary/protocol endpoint

AUC

Time frame:Predose and postdose 4、8、10、12、14、24、48、72、96、168、216、336 hours

concentration, descriptive

Secondary/protocol endpoint

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 endpoint
Secondary/protocol endpoint/low confidence

Change 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

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.