DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT05793450

CompletedPhase 1

Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment

Asset

Mazdutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

—

Enrollment

20

actual

Study population

Healthy volunteers, Renal impairment

Key I/E criteria

•eGFR ≥90•Healthy volunteers

Primary endpoints

•Cmax of IBI362•PK: Area Under the Concentration Versus Time Curve (AUC) of IBI362

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 IDNCT05793450
Org study IDCIBI362D102

Timeline

Milestones

Study first posted2023-03-31actual
Study start2023-05-05actual
Primary completion2023-09-18actual
Study completion2023-11-17actual
Last update posted2024-02-20actual

Assets

Investigational agents

Mazdutide

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•All Participants:

o The weight of male subjects is not less than 50 kg, and the body weight of female subjects is not less than 45 kg, and the body mass index (BMI) is within the range of 20~30 kilograms per meter squared (kg/m²), inclusive, at screening

•Healthy Participants:

-- Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function, assessed by estimated glomerular filtration rate (eGFR) ≥90 milliliters per minute (mL/min) at screening

•Participants with Renal Impairment:
–Males or females with stable mild to severe renal impairment, assessed by eGFR

Exclusion criteria

•All Participants:
–Pregnant or lactating women, or men or women who are of childbearing potential and are not willing to use contraception within 6 months from the screening period to the administration of the study drug
–Have known allergies to IBI362 or related compounds
–Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
–Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5× the upper limit of normal (ULN) or total bilirubin (TBL) >1× ULN
–Severe gastrointestinal diseases (such as active ulcer, pyloric obstruction, inflammatory bowel disease, etc.) occurred within 6 months before screening, or received gastrointestinal surgery or long-term use of drugs that directly affect gastrointestinal motility due to chronic gastrointestinal diseases
–Have a history of acute and chronic pancreatitis, or serum amylase and/or lipase ≥ 1.5× ULN at screening, or fasting Triglyceride ≥ 5.64 mmol/L (500 mg/dl)
•Participants with Renal Impairment:
–obstructive urinary tract diseases (such as urinary stones, urinary tract obstruction caused by abdominal space-occupying lesions, etc.) or renal dysfunction caused by special types of renal parenchymal damage (such as polycystic kidney, medullary sponge kidney, Renal tumors, etc.) and/or patients with renal impairment who have diseases that are not related to renal disease but can cause renal impairment (eg, renal artery stenosis, acute drug injury, severe infection, hypovolemia, heart failure, etc.).
–Have a history of kidney transplant
–The treatment medication and/or the treatment medication of other comorbid diseases have been taken stably for less than 1 month at screening, or there are new medications within 1 month before screening (except temporary or intermittent use of drugs, such as Erythropoietin once a month, or diuretics as needed, etc.), or received any drug known to alter renal tubular creatinine secretion within 14 days or 5 half-lives before screening, such as cimetidine D, trimethoprim or cibenzoline, etc.

Endpoints (2)

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

2 endpoints
Primary/protocol endpoint

Pharmacokinetics (PK): Maximum Concentration (Cmax) of IBI362

Time frame:Predose through 1344 hours postdose

Cmax

concentration, descriptive

Primary/protocol endpoint

PK: Area Under the Concentration Versus Time Curve (AUC) of IBI362

Time frame:Predose through 1344 hours postdose

AUC₀–∞

concentration, 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.