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RecruitingPhase 1

A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement

A Multi-center, Parallel Cohort, Open Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of HDM1002 in Subjects With Normal Hepatic Function and Hepatic Impairment.

Asset

HDM1002

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

40

estimated

Study population

Healthy volunteers, Hepatic impairment

Key I/E criterion

BMI ≥50

Primary endpoints

CmaxArea Under the Plasma Concentration-Time Profile From Time Zero ExtrapolatedArea Under the Plasma Concentration-Time Profile

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 IDNCT06985615
Org study IDHDM1002-109

Timeline

Milestones

Study start2025-03-18actual
Study first posted2025-05-22actual
Last update posted2025-05-22actual
Primary completion2026-01-14estimated
Study completion2026-05-14estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteersHepatic impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

1. Age and Sex: Chinese subjects aged 18-70 years (inclusive) at screening, regardless of gender. The normal hepatic function group and hepatic impairment group must be age-matched within ±10 years, with gender matching as close as possible (±1 subject per gender).

2. Body Weight and Body Mass Index (BMI): At screening, male subjects must weigh ≥50.0 kg, and female subjects ≥40.0 kg, with a BMI ranging from 19.0 to 32.0 kg/m² (inclusive).The normal hepatic function group and hepatic impairment group must be weight-matched within ±10 kg.

Exclusion criteria

1. History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2; or serum calcitonin ≥50 ng/L at screening.

2. History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to signing the informed consent form (ICF).

3. History of acute gallbladder disease within 3 months prior to signing the ICF.

4. History of Malignancy: Diagnosis of any malignancy within 5 years prior to ICF signing (except basal cell carcinoma treated with curative intent and deemed cured).

5. Severe Systemic Diseases: History of severe cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine, or other systemic diseases (e.g., acute myocardial infarction, severe depression, gastric ulcer, uremia) within 1 year prior to ICF signing.

6. Conditions Affecting Drug Pharmacokinetics: Presence of dysphagia or any condition that, on the investigator's judgment, may impact drug absorption, distribution, metabolism, or excretion (e.g., active inflammatory bowel disease, gastrectomy, intestinal resection) at screening.

7. Severe Hypoglycemia: Episode of severe hypoglycemia within 3 months prior to screening.

8. Allergy or Intolerance: History of allergic diseases (e.g., asthma, urticaria, eczematous dermatitis) or known intolerance/allergy to glucagon-like peptide-1 receptor (GLP-1R) agonists.

9. Hepatic Function Normal Group Exclusions:a) History of chronic liver disease, including hepatitis, hepatitis B, or hepatitis C, or positive for hepatitis B surface antigen (HBsAg) or hepatitis C virus antibody (anti-HCV) at screening.b) Positive Treponema pallidum antibody.c) Use of any medication within 28 days or 5 elimination half-lives (whichever is longer) prior to the first study drug administration.

10. Hepatic Impairment Group Exclusions:a) Hepatocellular carcinoma, hepatorenal syndrome, or limited life expectancy (defined as <1 year for the hepatic impairment cohort).b) Cirrhosis complications (e.g., gastrointestinal bleeding, severe hypoglycemia) within 3 months prior to screening.c) Use of any medication within 7 days or 5 half-lives (whichever is longer) prior to the first study drug administration that may affect HDM1002 pharmacokinetics (PK).

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.

Safety / tolerability / PK

4 endpoints
Primary/protocol endpoint

Maximum Plasma Concentration (Cmax)

Time frame:Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.

Cmax

concentration, descriptive

Primary/protocol endpoint

Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)

Time frame:Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t)

Time frame:Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

Fraction of Unbound Drug in Plasma (fu)

Time frame:Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.

ratio, descriptive

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.