A Pharmacokinetic Study of HDM1005 Injection in Participants With Impaired Renal Function and Healthy Participants

A Multicenter, Single-Dose, Parallel-Group, Open-Label Pharmacokinetic Study of HDM1005 Injection in Participants With Impaired Renal Function and Healthy Participants

The purpose of this study is to evaluate the pharmacokinetic profile and safety of a single subcutaneous injection of HDM1005 solution in participants with impaired kidney function compared to healthy participants.

Study Overview

• Status: Not yet recruiting
• Conditions: Overweight; Obese
• Intervention / Treatment: Drug: HDM1005

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Guiyu Liu; Phone Number: +86-0571 89908523; Email: liuguiyu@eastchinapharm.com

Study Locations

• China
  • Beijing, China, 100191
    • Peking University Third Hospital
    • Principal Investigator: Yue Wang
    • Principal Investigator: Dongyang Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Aged between 18 and 75 years (inclusive), regardless of gender.
• Body weight ≥50.0 kg for males and ≥45.0 kg for females; body mass index (BMI) between 19.0 and 35.0 kg/m² (inclusive).
• For participants with renal impairment: prior diagnosis of chronic kidney disease (CKD). Absolute GFR calculated by CKD-EPI and BSA formula: ≥30 and <60 mL/min for moderate impairment; ≥15 and <30 mL/min for severe impairment.
• For participants with normal renal function: aged 18 to 75 years (inclusive); body weight ≥50.0 kg (male) or ≥45.0 kg (female); BMI 19.0-35.0 kg/m².
• In the investigator's opinion, suitable for the study based on medical history, clinical laboratory tests, vital signs, 12-lead ECG, and physical examination at screening.
• Provide signed informed consent before any trial procedures; fully understand the trial content, procedures, and possible adverse reactions.
• Able to communicate well with the investigator and understand and comply with all study requirements.

Exclusion Criteria:

• Personal or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
• History of chronic pancreatitis, or an episode of acute pancreatitis or acute cholecystitis within 3 months prior to screening.
• Severe hypoglycemic events or recurrent hypoglycemic events (≥3 episodes per week) within 3 months prior to screening.
• For the renal impairment group: presence of obstructive urinary tract disease, acute kidney injury, or other clinically significant systemic diseases beyond chronic kidney disease and its complications, which in the investigator's opinion make the participant unsuitable. For the normal renal function group: presence of clinically significant diseases involving any of the following systems at screening (including but not limited to respiratory, circulatory, digestive, hematopoietic, endocrine, immune, skin, nervous, psychiatric, ear-nose-throat, etc.), which in the investigator's opinion make the participant unsuitable.
• Known intolerance or allergy to GLP-1R and/or GIPR agonists, or known allergy to HDM1005 or any component of the formulation.
• Major surgery within 6 months prior to screening, or incomplete healing of surgical incisions, or planned surgery during the study.
• Blood donation or blood loss ≥400 mL, or use of blood products within 3 months prior to screening or between screening and dosing.
• History of drug abuse (e.g., morphine, ketamine, tetrahydrocannabinolic acid, methamphetamine, methylenedioxymethamphetamine, cocaine) or positive urine drug test at screening.
• History of needle phobia or hemophobia, difficulty with blood collection, or inability to tolerate venipuncture.
• Any other condition (medical, psychological, psychiatric, social, or geographic factors) that, in the investigator's opinion, makes the participant unsuitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 - Healthy Control	Drug: HDM1005; 2.0 mg, SC, single dose
Experimental: Group 2 - Moderate Renal Impairment	Drug: HDM1005; 2.0 mg, SC, single dose
Experimental: Group 3 - Severe Renal Impairment	Drug: HDM1005; 2.0 mg, SC, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Concentration (Cmax)	Cmax of HDM1005	Up to Day 29
Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)]	AUC(0- t) of HDM1005	Up to Day 29

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apparent clearance (CL/F)	CL/F of HDM1005	Up to Day 29
Apparent distribution(Vz/F)	Vz/F of HDM1005	Up to Day 29
Adverse events (AEs)	Number of subjects reporting AEs	Up to Day 29

Collaborators and Investigators

• Sponsor: Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): June 12, 2026
• Study Completion (Estimated): July 31, 2026

Study Registration Dates

• First Submitted: April 23, 2026
• First Submitted That Met QC Criteria: April 23, 2026
• First Posted (Actual): April 30, 2026

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: HDM1005-105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No