A Study of Retatrutide (LY3437943) on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Overweight or Obesity; CKD; Type 2 Diabetes

Treatments: Drug: Placebo; Drug: Retatrutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT05936151

2023-504583-42-00 (Other Identifier)

J1I-MC-GZBU (Other Identifier)

18725

Details and patient eligibility

About

The main purpose of this study is to investigate the effect of retatrutide on renal function in participants with overweight or obesity and chronic kidney disease (CKD), with or without Type 2 Diabetes (T2D). The study will last around 31 weeks.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have a body mass index (BMI) ≥27 kilogram/square meter (kg/m²)

• Have either

  • no T2D with an HbA1c < 6.5% or
  • have T2D with an HbA1c ≤ 9.5% and treated with diet and exercise only or with stable doses of up to 3 oral antihyperglycemic medications, with or without basal insulin for at least 90 days before screening.

• Have been diagnosed with chronic kidney disease (CKD).

Exclusion criteria

• Have a self-reported change in body weight >5 kilogram (kg) (11 pounds) within 90 days before screening.
• Have used in 90 days before the screening any of the following antihyperglycemic class: Dipeptidyl Peptidase IV (DPP4) inhibitors, amylin analogs, glucagon-like peptide-RA (GLP-RA), gastric inhibitory polypeptide (GIP)/GIP-1 RA, and short acting or rapid acting insulins or U500 Insulin
• Have a prior or planned surgical treatment for obesity
• Have Type 1 Diabetes (T1D)
• Have acute or chronic hepatitis
• Have a history of malignant disease within 5 years before screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Retatrutide

Experimental group

Description:

Participants will receive multiple doses of retatrutide subcutaneously (SC)

Treatment:

Drug: Retatrutide

Placebo

Placebo Comparator group

Description:

Participants will receive LY3437943

Treatment:

Drug: Placebo