Renal InsufficiencyPhase 1NCT03482024
A Study of Tirzepatide (LY3298176) in Participants With Impaired Kidney Function
A Phase 1 study testing Tirzepatide in people with Renal Insufficiency and End Stage Renal Disease, run by Eli Lilly and Company at 4 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, End Stage Renal Disease
- What is being tested?
- Tirzepatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 4 sitesUnited States
- Study dates
- 30 Mar 2018to 19 Aug 2019
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- -- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
United States4 sites
High Point Clinical Trials Center
High Point, North Carolina, 27265
Clinical Pharmacology of Miami
Miami, Florida, 33014
Orlando Clinical Research Center
Orlando, Florida, 32809
Orange County Research Center
Tustin, California, 92780
About this study
Official title: Pharmacokinetics of Tirzepatide Following Administration to Subjects With Impaired Renal Function
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.
- Conditions
- Renal Insufficiency, End Stage Renal Disease
- Being tested
- Tirzepatide
- Medical subject headings
- Renal Insufficiency, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TirzepatideDrug
Also called LY3298176
Administered SC.
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide - Control | Experimental | Group 1 - Tirzepatide 5 milligrams (mg) administered subcutaneously (SC) to healthy participants with normal renal function. Receives: Drug: Tirzepatide |
| Tirzepatide - Mild Renal Impairment | Experimental | Group 2 - Tirzepatide 5mg administered SC to participants with mild renal impairment. Receives: Drug: Tirzepatide |
| Tirzepatide - Moderate Renal Impairment | Experimental | Group 3 - Tirzepatide 5mg administered SC to participants with moderate renal impairment. Receives: Drug: Tirzepatide |
| Tirzepatide - Severe Renal Impairment | Experimental | Group 4 - Tirzepatide 5mg administered SC to participants with severe renal impairment. Receives: Drug: Tirzepatide |
| Tirzepatide - End Stage Renal Disease (ESRD) | Experimental | Group 5 - Tirzepatide 5mg administered SC to participants with ESRD. Receives: Drug: Tirzepatide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Tlast (AUC[0-tlast])
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to tlast (AUC[0-tlast]) of Tirzepatide was evaluated.
Measured: Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose
PK: Maximum Concentration of Tirzepatide
Cmax is the maximum observed concentration of Tirzepatide.
Measured: Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose
PK: Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC[0-inf])
Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Tirzepatide was evaluated.
Measured: Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start30 Mar 2018
- Primary completion19 Aug 2019
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03482024
- Sponsor's protocol ID
- 17021
- Other IDs
- I8F-MC-GPGG
- Status last verified
- 1 Jun 2022
- First submitted
- 23 Mar 2018
- Last updated
- 23 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Urva S, Quinlan T, Landry J, Martin J, Loghin C. Effects of Renal Impairment on the Pharmacokinetics of the Dual GIP and GLP-1 Receptor Agonist Tirzepatide. Clin Pharmacokinet. 2021 Aug;60(8):1049-1059. doi: 10.1007/s40262-021-01012-2. Epub 2021 Mar 29.
PubMed 33778934
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Tirzepatide Following Administration to Subjects With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT03482024
- Acronym / sponsor ID
- 17021
- Conditions
- Renal Insufficiency, End Stage Renal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2018 (actual)
- Primary completion
- 19 Aug 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 29 Mar 2018 (actual)
- Results
- Posted 23 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Tirzepatide - Control | Experimental | Drug: TirzepatideGroup 1 - Tirzepatide 5 milligrams (mg) administered subcutaneously (SC) to healthy participants with normal renal function. |
| Tirzepatide - Mild Renal Impairment | Experimental | Drug: TirzepatideGroup 2 - Tirzepatide 5mg administered SC to participants with mild renal impairment. |
| Tirzepatide - Moderate Renal Impairment | Experimental | Drug: TirzepatideGroup 3 - Tirzepatide 5mg administered SC to participants with moderate renal impairment. |
| Tirzepatide - Severe Renal Impairment | Experimental | Drug: TirzepatideGroup 4 - Tirzepatide 5mg administered SC to participants with severe renal impairment. |
| Tirzepatide - End Stage Renal Disease (ESRD) | Experimental | Drug: TirzepatideGroup 5 - Tirzepatide 5mg administered SC to participants with ESRD. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- All Participants:
- 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)
Key exclusion criteria (12 listed)
- All Participants:
- Participants with Renal Impairment or ESRD:
- Participants with T2DM and Renal Impairment or ESRD:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TirzepatideAlso: LY3298176Administered SC. | Drug | Tirzepatide - Control, Tirzepatide - End Stage Renal Disease (ESRD), Tirzepatide - Mild Renal Impairment, Tirzepatide - Moderate Renal Impairment, Tirzepatide - Severe Renal Impairment |
Primary outcome
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
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time Zero to tlast (AUC[0-tlast]) of Tirzepatide was evaluated.
PK: Maximum Concentration of Tirzepatide
Time frame: Predose, 8hours(h), 12h, 24h, 48h, 72h, 96h, 168h, 336h postdose
Cmax is the maximum observed concentration of Tirzepatide.
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
Area Under the Concentration Versus Time Curve from Time Zero to Infinity (AUC[0-inf]) of Tirzepatide was evaluated.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33778934Urva S, Quinlan T, Landry J, Martin J, Loghin C. Effects of Renal Impairment on the Pharmacokinetics of the Dual GIP and GLP-1 Receptor Agonist Tirzepatide. Clin Pharmacokinet. 2021 Aug;60(8):1049-1059. doi: 10.1007/s40262-021-01012-2. Epub 2021 Mar 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director
Eli Lilly and Company
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tirzepatide in people with Renal Insufficiency and End Stage Renal Disease, run by Eli Lilly and Company at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03482024, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2023.