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

Launched by HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO., LTD. · May 15, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a medication called HDM1002 to understand how it behaves in the body of people with liver issues (hepatic impairment) compared to healthy individuals. The main goal is to see if liver problems affect how the drug is processed in the body, which is important for determining its safety and effectiveness.

Eligible participants for the study are Chinese adults aged 18 to 70, both men and women, who weigh at least 50 kg for men and 40 kg for women, and have a body mass index (BMI) between 19 and 32. They will be grouped based on whether they have normal liver function or some level of liver impairment. Participants can expect to undergo health screenings and follow specific guidelines throughout the study. It's essential to know that individuals with certain health conditions, such as recent severe illnesses, specific types of cancer, or those on certain medications, may not qualify for the trial.

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Eligibility criteria

• 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).