Hepatic ImpairmentPhase 1NCT06985615
A Study of HDM1002 in Subjects With And Without Varying Degrees Of Hepatic Impairement
A Phase 1 study testing Single dose of HDM1002 on Day 1 in people with Hepatic Impairment and Healthy Volunteers, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of HDM1002 Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy Volunteers
- What is being tested?
- Single dose of HDM1002 on Day 1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2025to 14 May 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
- 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.
Who cannot join
- 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 ulcer, uremia) within 1 year prior to ICF signing.
- 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.
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- 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 (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.
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Liyan Miao, miaolysuzhou@163.com
Liyan Miao
About this study
Official title: 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.
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
- Hepatic Impairment, Healthy Volunteers
- Being tested
- Single dose of HDM1002 on Day 1
- Keywords
- HDM1002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single dose of HDM1002 on Day 1Drug
Single dose of HDM1002 will be administered on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Subjects Without Hepatic Impairment | Experimental | Not described Receives: Drug: Single dose of HDM1002 on Day 1 |
| Subjects With Mild Hepatic Impairment | Experimental | Not described Receives: Drug: Single dose of HDM1002 on Day 1 |
| Subjects With Moderate Hepatic Impairment | Experimental | Not described Receives: Drug: Single dose of HDM1002 on Day 1 |
| Subjects With Severe Hepatic Impairment | Experimental | Not described Receives: Drug: Single dose of HDM1002 on Day 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Plasma Concentration (Cmax)
Maximum observed plasma of HDM1002 concentration.
Measured: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.
Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf)
Area under the plasma HDM1002 concentration-time profile from time 0 extrapolated to infinite time.
Measured: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.
Area Under the Plasma Concentration-Time Profile From Time Zero to the Time of the Last Quantifiable Concentration (AUC0-t)
Area under the plasma HDM1002 concentration-time profile from time 0 extrapolated to the time of the last quantifiable concentration.
Measured: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.
Fraction of Unbound Drug in Plasma (fu)
fu = Cu/C (where Cu represents unbound concentration and C represents total concentration).
Measured: Predose (0 hours), 1, 2, 3, 4, 5, 6, 8, 10, 12, 24, 36, 48 and 72 hours post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2025
- Study start18 Mar 2025
- Primary completion14 Jan 2026 (estimated)
- Study completion14 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies of the same condition, open and under way.
- More trials run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06985615
- Sponsor's protocol ID
- HDM1002-109
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 22 May 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT06985615
- Acronym / sponsor ID
- HDM1002-109
- Conditions
- Hepatic Impairment, Healthy Volunteers
- Keywords
- HDM1002
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- 14 Jan 2026 (estimated)
- Study completion
- 14 May 2026 (estimated)
- First posted
- 22 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma Pharmacokinetic (PK) of HDM1002
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Subjects Without Hepatic Impairment | Experimental | Drug: Single dose of HDM1002 on Day 1 |
| Subjects With Mild Hepatic Impairment | Experimental | Drug: Single dose of HDM1002 on Day 1 |
| Subjects With Moderate Hepatic Impairment | Experimental | Drug: Single dose of HDM1002 on Day 1 |
| Subjects With Severe Hepatic Impairment | Experimental | Drug: Single dose of HDM1002 on Day 1 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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).
- 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.
Key exclusion criteria (10 listed)
- 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 ulcer, uremia) within 1 year prior to ICF signing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single dose of HDM1002 on Day 1Single dose of HDM1002 will be administered on Day 1 | Drug | Subjects With Mild Hepatic Impairment, Subjects With Moderate Hepatic Impairment, Subjects With Severe Hepatic Impairment, Subjects Without Hepatic Impairment |
Primary outcome
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.
Maximum observed plasma of HDM1002 concentration.
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.
Area under the plasma HDM1002 concentration-time profile from time 0 extrapolated to infinite time.
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.
Area under the plasma HDM1002 concentration-time profile from time 0 extrapolated to the time of the last quantifiable concentration.
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.
fu = Cu/C (where Cu represents unbound concentration and C represents total concentration).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Single dose of HDM1002 on Day 1 in people with Hepatic Impairment and Healthy Volunteers, run by Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liyan Miao (0512-67972858, miaolysuzhou@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2025.