DelfaGLP-1 Atlas

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Not yet recruitingPhase 1

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

Asset

HDM1005

Subcutaneous · GLP-1 / GIP dual

Listed sites

1

Recruiting sites

—

Enrollment

30

estimated

Study population

Healthy volunteers, Renal impairment

Key I/E criterion

•BMI 19-35

Primary endpoints

•Cmax•AUC

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07559240
Org study IDHDM1005-105

Timeline

Milestones

Study first posted2026-04-30actual
Last update posted2026-05-08actual
Study start2026-05-15estimated
Primary completion2026-06-12estimated
Study completion2026-07-31estimated

Assets

Investigational agents

HDM1005

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

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.

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

5 endpoints
Primary/protocol endpoint

Maximum Concentration (Cmax)

Time frame:Up to Day 29

concentration, descriptive

Primary/protocol endpoint

Area Under the Concentration Time Curve From Time Zero to t [ AUC(0- t)]

Time frame:Up to Day 29

concentration, descriptive

Secondary/protocol endpoint

Apparent clearance (CL/F)

Time frame:Up to Day 29

concentration, descriptive

Secondary/protocol endpoint

Apparent distribution(Vz/F)

Time frame:Up to Day 29

descriptive

Secondary/protocol endpoint

Adverse events (AEs)

Time frame:Up to Day 29

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.