BridgeMD
New treatment option for Hepatic Impairment
Official title A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement
ClinicalTrials.gov ID: NCT06985615
What this study is testing
What is Single dose of HDM1002 on Day 1?
Single dose of HDM1002 on Day 1 is an investigational medicine, being studied as a potential treatment for hepatic impairment.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of HDM1002
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70. Healthy volunteers may be eligible.
You may be able to join if
- Age and Sex: Chinese people aged 18-70 years (inclusive) at screening, regardless of gender. The normal hepatic function group and hepatic impairment...
- Body Weight and Body Mass Index (BMI): At screening, male people must weigh ≥50.0 kg, and female people ≥40.0 kg, with a BMI ranging from 19.0 to...
You likely can't join if
- History or family history of medullary thyroid carcinoma, thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2; or serum calcitonin ≥50...
- History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to signing the informed consent form (ICF).
- History of acute gallbladder disease within 3 months prior to signing the ICF.
- History of Malignancy: Diagnosis of any malignancy within 5 years prior to ICF signing (except basal cell carcinoma treated with curative intent and...
- Severe Systemic Diseases: History of severe cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine, or other systemic...
- Conditions Affecting Drug Pharmacokinetics: Presence of dysphagia or any condition that, on the investigator's judgment, may impact drug absorption...
See the full eligibility criteria
- Age and Sex: Chinese people 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...
- Body Weight and Body Mass Index (BMI): At screening, male people must weigh ≥50.0 kg, and female people ≥40.0 kg, with a BMI ranging from 19.0 to 32.0 kg/m² (inclusive).The normal hepatic function group and hepatic...
- 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.
- History of chronic pancreatitis or an episode of acute pancreatitis within 3 months prior to signing the informed consent form (ICF).
- History of acute gallbladder disease within 3 months prior to signing the ICF.
- 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).
- Severe Systemic Diseases: History of severe cardiovascular, neuropsychiatric, gastrointestinal, respiratory, urinary, endocrine, or other systemic diseases (e.g., acute myocardial infarction, severe depression, gastric...
- 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...
- Severe Hypoglycemia: Episode of severe hypoglycemia within 3 months prior to screening.
- 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.
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Suzhou, Jiangsu, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Suzhou, Jiangsu, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.