Actively Recruiting
A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement
Led by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. · Updated on 2025-05-22
40
Participants Needed
1
Research Sites
60 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of HDM1002
CONDITIONS
Official Title
A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Chinese subjects aged 18 to 70 years inclusive
- Subjects of any gender with age matching within ±10 years and gender matching within ±1 subject per group
- Male subjects weighing at least 50.0 kg and female subjects weighing at least 40.0 kg
- Body Mass Index (BMI) between 19.0 and 32.0 kg/m² inclusive
- Weight matching within ±10 kg between normal hepatic function and hepatic impairment groups
You will not qualify if you...
- History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2
- Serum calcitonin level ≥ 50 ng/L at screening
- History of chronic pancreatitis or acute pancreatitis episode within 3 months prior to consent
- History of acute gallbladder disease within 3 months prior to consent
- Diagnosis of any malignancy within 5 years prior to consent, except cured basal cell carcinoma
- History of severe cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine, or other systemic diseases within 1 year prior to consent
- Conditions affecting drug pharmacokinetics such as dysphagia, active inflammatory bowel disease, gastrectomy, or intestinal resection at screening
- Severe hypoglycemia episode within 3 months prior to screening
- History of allergic diseases or known intolerance/allergy to GLP-1 receptor agonists
- For normal liver function group: history of chronic liver disease, positive hepatitis B surface antigen or hepatitis C antibody, positive Treponema pallidum antibody, or medication use within 28 days or 5 half-lives prior to dosing
- For hepatic impairment group: hepatocellular carcinoma, hepatorenal syndrome, limited life expectancy (<1 year), cirrhosis complications within 3 months, or medication use affecting HDM1002 pharmacokinetics within 7 days or 5 half-lives prior to dosing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Actively Recruiting
Research Team
L
Liyan Miao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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