A Study of Tirzepatide (LY3298176) in Participants With Impaired Kidney Function

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-30

Study Completion Date

2019-08-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to assess how fast tirzepatide gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05536804

Overweight Obesity Chronic Kidney Disease +2 more

ACTIVE_NOT_RECRUITING PHASE2

Clinical, Morphometric and Biochemical Effects on Adiposopathy Associated With the Use of GLP-1RA in CKD

NCT07309094

Chronic Kidney Disease stage3 Chronic Kidney Disease stage4 Chronic Kidney Disease Stage 1 +3 more

RECRUITING

Glucagon-Like Peptide-1 Receptor Agonist in ADPKD

NCT06582875

Autosomal Dominant Polycystic Kidney Obesity

RECRUITING PHASE2

Efficacy and Safety of Tirzepatide (Spartina) in Chronic Kidney Failure

NCT07176663

Obesity

NOT_YET_RECRUITING NA

DIALYSIS-TIR Study

NCT06042153

Type 2 Diabetes End Stage Renal Disease on Dialysis

ACTIVE_NOT_RECRUITING PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Renal Insufficiency End Stage Renal Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Tirzepatide - Control

Group 1 - Tirzepatide 5 milligrams (mg) administered subcutaneously (SC) to healthy participants with normal renal function.

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC.

Tirzepatide - Mild Renal Impairment

Group 2 - Tirzepatide 5mg administered SC to participants with mild renal impairment.

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC.

Tirzepatide - Moderate Renal Impairment

Group 3 - Tirzepatide 5mg administered SC to participants with moderate renal impairment.

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC.

Tirzepatide - Severe Renal Impairment

Group 4 - Tirzepatide 5mg administered SC to participants with severe renal impairment.

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC.

Tirzepatide - End Stage Renal Disease (ESRD)

Group 5 - Tirzepatide 5mg administered SC to participants with ESRD.

Group Type EXPERIMENTAL

Tirzepatide

Intervention Type DRUG

Administered SC.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tirzepatide

Administered SC.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY3298176

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All Participants:

* Women not of childbearing potential may participate and include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or postmenopausal
* Are between the body mass index (BMI) of 19.0 and 40.0 kilograms per meter squared (kg/m²), inclusive, at screening
* Healthy Participants:

\-- Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function, assessed by estimated glomerular filtration rate (eGFR) ≥90 milliliters per minute (mL/min) at screening
* Participants with Renal Impairment or ESRD:

\-- Males or females with stable mild to severe renal impairment, assessed by eGFR or with ESRD (having received hemodialysis for at least 3 months)
* Participants with Type 2 Diabetes Mellitus (T2DM) and Renal Impairment or ESRD:

* Have T2DM controlled with diet or exercise alone or stable on metformin for at least 8 weeks
* Taking stable doses of over-the-counter or prescription medications (eg, antihypertensive agents, aspirin, lipid-lowering agents) for treatment of concurrent medical conditions are permitted to participate providing they have been stable on their treatment regimen for at least 4 weeks
* Have a hemoglobin A1c (HbA1c) ≥7.0% and ≤11.0% at screening

Exclusion Criteria

* All Participants:

* Women of childbearing potential
* Have known allergies to tirzepatide or related compounds
* Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
* Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2× the upper limit of normal (ULN) or total bilirubin (TBL) \>1.5× ULN
* Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or GI disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
* Participants with Renal Impairment or ESRD:

* Have hemoglobin \<8.5 grams per deciliter (g/dL) or significant active hematological disease from causes other than underlying renal disease.
* Have used any drug indicated for medical care of the participant's renal impairment, which is not established in dose and administered for at least 7 days before LY3298176 administration
* Participants with T2DM and Renal Impairment or ESRD:

* Have taken any glucose-lowering medications other than metformin, including insulin, in the past 3 months before screening
* Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before entry into the study or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes