Clinical trial

A Phase 2b, Double-Blind Study to Investigate the Effect of LY3437943 on Renal Function in Participants With Overweight or Obesity and Chronic Kidney Disease With or Without Type 2 Diabetes

Name
18725
Description
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.
Trial arms
Trial start
2023-07-20
Estimated PCD
2025-11-25
Trial end
2025-11-25
Status
Recruiting
Phase
Early phase I
Treatment
LY3437943
Administered SC
Arms:
LY3437943
Placebo
Administered SC
Arms:
Placebo
Size
120
Primary endpoint
Change from Baseline in Glomerular Filtration Rate (GFR)
Baseline, Week 24
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Phase 2b', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}
Updated at
2024-04-08

1 organization

2 products

3 indications

Product
Placebo
Indication
Obesity
Indication
Type 2 Diabetes
Product
LY3437943