GLP-1 Peptide Atlas, by Delfa

← Trials/Trial dossier/NCT03482024

CompletedPhase 1Results posted

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

Pharmacokinetics of Tirzepatide Following Administration to Subjects With Impaired Renal Function

Lead sponsor

Eli Lilly and Company

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

—

Enrollment

actual

Study population

Healthy volunteers, Renal impairment

Key I/E criteria

•BMI 19-40•HbA1c 7-11%•eGFR ≥90•Healthy volunteers

Primary endpoints

•AUC of Tirzepatide•PK: Maximum Concentration of Tirzepatide•PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT03482024

Org study ID17021

Secondary IDI8F-MC-GPGGEli Lilly and Company

Timeline

Milestones

Study first posted2018-03-29actual

Study start2018-03-30actual

Primary completion2019-08-19actual

Study completion2019-08-19actual

Last update posted2023-03-23actual

Results first posted2023-03-23actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Healthy volunteersRenal impairment

Eligibility

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

6 endpoints

Primary/registry result

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Tlast (AUC[0-tlast])

Time frame:Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose

concentration, descriptive

Posted result

Group	Value (geometric_mean), Nanogramhour per Millilitre (ngh/mL)	95% CI
Tirzepatide - Control	78400	—
Tirzepatide - Mild Renal Impairment	81900	—
Tirzepatide - Moderate Renal Impairment	98300	—
Tirzepatide - Severe Renal Impairment	81200	—
Tirzepatide - End Stage Renal Disease (ESRD)	88500	—

Primary/registry result

PK: Maximum Concentration of Tirzepatide

Time frame:Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose

Cmax

concentration, descriptive

Posted result

Group	Value (geometric_mean), Nanogram per Millilitre (ng/mL)	95% CI
Tirzepatide - Control	339	—
Tirzepatide - Mild Renal Impairment	353	—
Tirzepatide - Moderate Renal Impairment	369	—
Tirzepatide - Severe Renal Impairment	417	—
Tirzepatide - End Stage Renal Disease (ESRD)	347	—

Primary/registry result

PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC[0-inf])

Time frame:Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose

AUC₀–∞

concentration, descriptive

Posted result

Group	Value (geometric_mean), Nanogramhour per Millilitre (ngh/mL)	95% CI
Tirzepatide - Control	80500	—
Tirzepatide - Mild Renal Impairment	84200	—
Tirzepatide - Moderate Renal Impairment	10400	—
Tirzepatide - Severe Renal Impairment	83000	—
Tirzepatide - End Stage Renal Disease (ESRD)	93400	—

Primary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Tlast (AUC[0-tlast])

Time frame:Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Concentration of Tirzepatide

Time frame:Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose

Cmax

concentration, descriptive

Primary/protocol endpoint

PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC[0-inf])

Time frame:Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose

AUC₀–∞

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Effects of Renal Impairment on the Pharmacokinetics of the Dual GIP and GLP-1 Receptor Agonist Tirzepatide.
Clinical pharmacokinetics2021 Aug (month)PMID33778934doi:10.1007/s40262-021-01012-2via clinicaltrials gov reference derived + pubmed nct search

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.