Evaluating the effects of hepatic impairment on HDM1002

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.

This study tests how different levels of liver function affect the way the drug HDM1002 works in Chinese adults aged 18-70.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. (industry)
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT06985615 on ClinicalTrials.gov

What this trial studies

This study aims to assess how varying degrees of hepatic impairment affect the pharmacokinetics of HDM1002 in subjects. Participants will receive a single dose of HDM1002, and the study will compare the drug's behavior in individuals with normal liver function against those with hepatic impairment. The study focuses on Chinese adults aged 18-70, ensuring age and gender matching between groups. The goal is to determine any clinically meaningful differences in drug metabolism related to liver function.

Who should consider this trial

Good fit: Ideal candidates are Chinese adults aged 18-70 with either normal hepatic function or varying degrees of hepatic impairment.

Not a fit: Patients with a history of certain thyroid conditions, pancreatitis, or malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and management of drug dosing in patients with liver impairment.

How similar studies have performed: While studies on pharmacokinetics in hepatic impairment are common, the specific approach of this study with HDM1002 is novel.

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).

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University — Suzhou, Jiangsu, China (RECRUITING)

Study contacts

• Study coordinator: Liyan Miao

Conditions: Hepatic Impairment, Healthy Volunteers, HDM1002