DelfaGLP-1 Atlas

← Trials/Trial dossier/NCT03940742

CompletedPhase 1Results posted

A Study of Tirzepatide in Participants With Impaired Liver Function

A Single Dose Pharmacokinetic Study of Tirzepatide in Subjects With Varying Degrees of Hepatic Impairment

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

3

Recruiting sites

—

Enrollment

32

actual

Study population

Healthy volunteers, Hepatic impairment, Type 2 diabetes

Key I/E criteria

•BMI 19-40•HbA1c 6-11%•Healthy volunteers

Primary endpoints

•AUC of Drug From Zero To Infinity (AUC[0-∞]) of Tirzepatide•PK: Maximum Observed Drug Concentration (Cmax) 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 IDNCT03940742
Org study ID17102
Secondary IDI8F-MC-GPGQEli Lilly and Company

Timeline

Milestones

Study first posted2019-05-07actual
Study start2019-07-22actual
Primary completion2020-09-22actual
Study completion2020-09-22actual
Last update posted2023-03-24actual
Results first posted2023-03-24actual

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Healthy volunteersHepatic impairmentType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age85 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

All Participants:

•Women of childbearing potential are excluded from the study.
•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 liver function

Participants with Impaired Liver Function:

•Males or females with chronic mild, moderate and severe liver impairment, assessed by Child-Pugh scoring
•Have type 2 diabetes mellitus (T2DM) controlled with diet or exercise alone or on stable doses of metformin for at least 8 weeks
•Have a hemoglobin A1c (HbA1c) ≥6.0% and ≤11.0% at screening

Exclusion criteria

All Participants:

•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 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 Impaired Liver Function:

•Have hemoglobin <8.5 grams per deciliter (g/dL)
•Have kidney function that is significantly impaired at screening
•Have taken any glucose-lowering medications other than metformin, including insulin, in the past 3 months before screening
•Have brain function impaired significantly due to liver condition

Endpoints (4)

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

4 endpoints
Primary/registry result

Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of Tirzepatide

Time frame:Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose

AUC₀–∞

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram*hour per milliliter (ng*h/mL)95% CI
Control (Normal Hepatic Function)84300—
Mild Hepatic Impairment102000—
Moderate Hepatic Impairment82000—
Severe Hepatic Impairment77000—
Ratio of geometric least squares mean1.0890% CI0.879 – 1.32
Ratio of geometric least squares mean0.96090% CI0.790 – 1.17
Ratio of geometric least squares mean0.85290% CI0.699 – 1.04
Primary/registry result

PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide

Time frame:Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose

Cmax

concentration, descriptive

Posted result

GroupValue (geometric_mean), ng/mL95% CI
Control (Normal Hepatic Function)510—
Mild Hepatic Impairment509—
Moderate Hepatic Impairment516—
Severe Hepatic Impairment521—
Ratio of geometric least squares mean0.91690% CI0.726 – 1.16
Ratio of geometric least squares mean1.0090% CI0.802 – 1.25
Ratio of geometric least squares mean0.97290% CI0.784 – 1.21
Primary/protocol endpoint

Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of Tirzepatide

Time frame:Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose

AUC₀–∞

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Observed Drug Concentration (Cmax) of Tirzepatide

Time frame:Predose, 8, 12, 24, 48, 72, 96, 168 and 336 post dose

Cmax

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

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.