A Pilot Study of Tirzepatide in Participants With Overweight or Obesity and Chronic Kidney Disease With Type 2 Diabetes/Prediabetes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011737

Enrollment

Registered

2026-03-18

Start date

2026-04-12

Completion date

Unknown

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Tirzepatide Administration • Dose levels: 2.5 mg, 5 mg, 7.5 mg, and 10 mg • Frequency and route of administration: Subcutaneous injection once weekly using a single-use pen device • Dose escala

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Age = 20 years and = 65 years

Exclusion criteria

Exclusion criteria: - Diagnosis of type 1 diabetes mellitus. - ALT or AST = 3 times the upper limit of normal (ULN). - eGFR < 25 mL/min/1.73 m², calculated using the CKD-EPI equation. - Use of GLP-1 receptor agonists within 3 months prior to screening. - Use of DPP-4 inhibitors within 2 weeks prior to screening. - Contraindications to renal biopsy, including bleeding tendency or inability to temporarily discontinue anticoagulant or antiplatelet therapy. - History of diagnosed psychiatric disorders requiring treatment. - Presence of systemic rheumatic disease or systemic infection. - History of treatment with corticosteroids or immunosuppressive agents within 6 months prior to screening. - Pregnancy or planned pregnancy during the study period. - Proliferative diabetic retinopathy or severe non-proliferative diabetic retinopathy. - Self-reported body weight change exceeding 5 kg within 90 days prior to screening. - History of or planned surgical, medical, endoscopic, or device-based treatment for obesity. - Clinically significant gastric emptying abnormalities or chronic use of medications that affect gastrointestinal motility. - Personal or family history of diabetic ketoacidosis, hyperosmolar state/coma, medullary thyroid carcinoma, multiple endocrine neoplasia syndrome type 2 (MEN2), or pancreatitis. - Known allergy to shellfish or iodine.

Design outcomes

Primary

Measure	Time frame
6-month change in renal sinus fat and perirenal fat thickness	—

Secondary

Measure	Time frame
Glomerular filtration rate (GFR);urine albumin-to-creatinine ratio (UACR);renal fat	—

Countries

Korea, Republic of

Contacts

Public ContactNan Hee Kim

Korea University Ansan Hospital

nhkendo@gmail.com+82-2-412-6715

Outcome results