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

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Lilly

Status and phase

Enrolling
Phase 2

Conditions

Overweight or Obesity
CKD
Type 2 Diabetes

Treatments

Drug: Placebo
Drug: LY3437943

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 lasts 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

120 participants in 2 patient groups, including a placebo group

LY3437943
Experimental group
Description:
Participants will receive multiple doses of LY3437943 subcutaneously (SC)
Treatment:
Drug: LY3437943
Placebo
Placebo Comparator group
Description:
Participants will receive LY3437943
Treatment:
Drug: Placebo

Trial contacts and locations

36

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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