A Study of Tirzepatide (LY3298176) in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes (TREASURE-CKD)

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Chronic Kidney Disease; Overweight; Obesity; Type 2 Diabetes; T2D

Treatments: Drug: Placebo; Drug: Tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05536804

2023-506082-60-00 (Other Identifier)

I8F-MC-GPIG (Other Identifier)

2021-005273-47 (EudraCT Number)

17217

Details and patient eligibility

About

We are doing this study to learn more about how tirzepatide may help fight chronic kidney disease in people with obesity with or without type 2 diabetes (T2D).

The study will last about 56 weeks and include up to 12 visits.

Enrollment: 140 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All participants with or without diabetes:

• Have a Body Mass Index (BMI) ≥27 kilogram/square meter (kg/m²) at screening
• Diagnosed with chronic kidney disease (CKD)
• Has an estimated glomerular filtration rate (eGFR) ≥25 to ≤60 ml/min/1.73 m² or eGFR ≥25 to ≤75 ml/min/1.73 m² if urine albumin-to-creatinine ratio (UACR) >30 milligram/gram (mg/g)
• Have been receiving an angiotensin-converting enzyme (ACE) or angiotensin II receptor blockers (ARB) that is considered the maximal appropriate dose by the investigator for treatment of chronic kidney disease or hypertension (unless the participant has low blood pressure or hypotension)

Participants without diabetes:

• Have Hemoglobin A1c (HbA1c) <6.5% at screening

Participants with Type 2 diabetes:

• Have been diagnosed at least 180 days prior to screening
• Have HbA1c ≤9.5% at screening

Exclusion criteria

All participants:

• Have a self-reported change in body weight >5 kilogram (kg) within 90 days prior to screening.
• Have a prior or planned surgical treatment for obesity
• Have or plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 180 days
• Have eGFR <25 mL/min/1.73m² calculated by using creatinine-based chronic kidney disease epidemiology collaboration (CKD-EPI) equations, as determined by central laboratory at screening.
• Have a history of unstable or rapidly progressing renal disease according to investigator judgment
• Have a known clinically significant gastric emptying abnormality (for example, severe diabetic gastroparesis or gastric outlet obstruction) or chronically take drugs that directly affect GI motility)
• Have had a history of chronic or acute pancreatitis

Participants with T2D:

• Have history of proliferative diabetic retinopathy or diabetic macular edema or non-proliferative diabetic retinopathy that requires acute treatment.
• Have been diagnosed with type 1 diabetes (T1D) or have history of ketoacidosis or hyperosmolar state/coma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 2 patient groups, including a placebo group

Tirzepatide

Experimental group

Description:

Tirzepatide administered subcutaneously (SC)

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Placebo administered SC

Treatment:

Drug: Placebo