Diabetic NephropathyPhase 1/2NCT01774981
Study of LY3016859 in Participants With Diabetic Nephropathy
A Phase 1/2 study testing LY3016859 in people with Diabetic Nephropathy, run by Eli Lilly and Company at 7 sites in 2 countries.
Trial summary
The purpose of this two-part study is to investigate the safety, tolerability and efficacy of LY3016859 after multiple intravenous (IV) dosing's in participants with diabetic nephropathy (DN). Part A will be dose escalation for safety and tolerability and Part B will evaluate Proteinuria. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetic Nephropathy
- What is being tested?
- LY3016859
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Mar 2013to Aug 2015
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stable diabetic kidney disease (DKD) while taking Standard of Care medication (SOC), as defined by:
- Estimated glomerular filtration rate (eGFR) less than (<) 90 milliliter per minute per 1.73 square meter (ml/min/1.73m²) as determine utilizing the Modification of Diet in Renal Disease (MDRD) equation
- Taking an angiotensin convertible enzyme (ACE) inhibitor or angiotensin II receptor blocker (ARB) at a stable dose for greater than or equal to (≥) 2 months prior to randomization and agree to continue to take such throughout the duration of the study
- Type 1 or Type 2 diabetes on a stable treatment regimen and adequately controlled in the opinion of the investigator
- First morning protein-creatine ratio (PCR) at screening ≥400 milligrams per gram (mg/g) (Part B only)
- Clinical chemistry labs within acceptable range for the participant population, as per investigator judgment
Show all 18Show fewer
- Men and women of non-childbearing potential as determined by medical history and physical examination
- Non-vasectomized male participants must agree to use a medically accepted method of contraception with all sexual partners during the study and for 90 days following the final dosing. Medically accepted effective forms of contraception may include condoms with contraceptive foam or having partners use diaphragms with contraceptive jelly or cervical caps with contraceptive jelly
- Female participants must be postmenopausal or surgically sterile to participate in this study. This is defined as females between age 45 to 75 years, inclusive, and either 12 months without a menstrual period [no follicle stimulating hormone (FSH) test required] or 6-12 months without a menstrual period and follicle stimulating hormone (FSH) greater than (>) 40 international units per liter (IU/L)
- Must weigh ≥50 kilograms (kg) at time of screening and dosing
- Acceptable sitting blood pressure (BP) per the following American Heart Association (AHA) guidelines:
- Normal: systolic blood pressure (SBP) <120 millimeters of mercury (mmHg) and diastolic blood pressure (DBP) <80 mmHg
- Prehypertension: SBP 120-139 or DBP 80-89
- High Blood Pressure (Hypertension) Stage 1: SBP 140-159 mmHg or DBP 90-99
- Have given written informed consent prior to any study-specific procedures
- Are reliable and willing to make themselves available for the duration of the study and are willing to follow site specific study procedures
- Have venous access sufficient to allow blood sampling
- Have laboratory values and other safety parameters that are, in the opinion of the investigator, acceptable fo participation for the study
Who cannot join
- Have a diagnosis of chronic kidney disease (CKD) other than DKD, (hypertensive nephrosclerosis superimposed on DKD is acceptable)
- Have SBP >160 mmHg or DBP >100 mmHg
- o Individuals with Stage 1 BP elevation (SBP 140-159 mmHg or DBP 90-99 mmHg) on some occasions during study, may be acceptable, as long as only non-protein-lowering antihypertensives are adjusted to achieve target BP goals (<140/90 mmHg)
- Current use of (or within 2 weeks of enrollment), or projected need for a renin inhibitor or aldosterone antagonist, or a combination of Angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEi/ARB)
- Individuals in whom dialysis or transplantation is anticipated within 6 months of screening
- Have a history of acute kidney injury within 3 months of screening
Show all 21Show fewer
- Are currently enrolled in, or discontinued within the last 60 days from, a clinical trial involving an investigational drug that has not received regulatory approval for any indication and/or have received treatment with biologic agents (such as monoclonal antibodies) within 3 months or 5 half-lives of the administered drug (whichever is longer) prior to dosing
- Have previously completed or withdrawn from this study or any other study investigating LY3016859
- Have a diagnosis of Class III or IV congestive heart failure (as defined by the New York Heart Association)
- Have an abnormality in the 12-lead Electrocardiogram (ECG) that, in the opinion of the investigator increases the risks associated with participating in the study. In addition, individuals with the following findings will be excluded:
- Confirmed corrected QT (QTcF) interval >450 milliseconds (msec) for men and >470 msec for women
- Irregular rhythms other than sinus arrhythmia or occasional, rare supraventricular ectopic beats
- History of unexplained syncope
- Family history of unexplained sudden death or sudden death due to long QT syndrome
- T-wave configurations are not of sufficient quality for assessing QT interval, as determined by the investigator
- Have evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies; have a history of cirrhosis or hepatitis C or are positive for hepatitis C antibody at the screening visit; are known to be hepatitis B surface antigen-positive or are positive for hepatitis B surface antigen at the screening visit
- Are unwilling to discontinue use of Chinese herbs for at least 2 weeks prior to randomization and for the duration of their study participation
- Are unwilling or unable to comply with the use of a data collection device to directly record data from the participant
- Have donated blood of more than 500 milliliters (mL) within the last 60 days prior to screening
- Have an average weekly alcohol intake that exceeds 21 units per week or are unwilling to stop alcohol intake within 48 hours of entry into study and for the duration of the study (1 unit = 12 ounces (oz) or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits)
- Individuals who, in the opinion of the investigator, show evidence of regular use of drugs of abuse
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Northeast Clinical Research Center
Bethlehem, Pennsylvania, 18017
Southeast Renal Research Institute
Chattanooga, Tennessee, 37408
Innovative Research of West Florida
Clearwater, Florida, 33756
TAD Clinical Research
Lufkin, Texas, 75904
Creighton University Medical Center
Omaha, Nebraska, 68131
Renal Associates, PA
San Antonio, Texas, 78215
Bulgaria1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Sofia, 1612
About this study
Official title: Study of the Safety and Efficacy of LY3016859 After Multiple Intravenous Dosing in Diabetic Nephropathy Patients
The purpose of this two-part study is to investigate the safety, tolerability and efficacy of LY3016859 after multiple intravenous (IV) dosing's in participants with diabetic nephropathy (DN). Part A will be dose escalation for safety and tolerability and Part B will evaluate Proteinuria.
- Conditions
- Diabetic Nephropathy
- Being tested
- Placebo, LY3016859
- Medical subject headings
- Diabetic Nephropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Administered IV
LY3016859Drug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Placebo (Part A) | Placebo comparator | Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4. Receives: Drug: Placebo |
| 10 mg LY3016859 (Part A) | Experimental | Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. Receives: Drug: LY3016859 |
| 100 mg LY3016859 (Part A) | Experimental | Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. Receives: Drug: LY3016859 |
| 750 mg LY3016859 (Part A) | Experimental | Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. Receives: Drug: LY3016859 |
| Placebo (Part B) | Placebo comparator | Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. Receives: Drug: Placebo |
| 50 mg LY3016859 (Part B) | Experimental | Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. Receives: Drug: LY3016859 |
| 250 mg LY3016859 (Part B) | Experimental | Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. Receives: Drug: LY3016859 |
| 750 mg LY3016859 (Part B) | Experimental | Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. Receives: Drug: LY3016859 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part B:Change From Baseline in Proteinuria
Proteinuria is defined as the ratio of protein to creatinine.
Measured: Baseline, 16 Weeks
Part A and Part B: Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs
Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
Measured: Baseline up to 32 Weeks
Secondary outcomes (2)
Part B: Change From Baseline in Proteinuria Over Time
Proteinuria is defined as the ratio of protein to creatinine.
Measured: Baseline, 19 Weeks
Part B: Change From Baseline in Albuminuria Over Time
Albuminuria is defined as the ratio of albumin to creatinine.
Measured: Baseline, 19 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2013 (estimated)
- Study startMar 2013
- Primary completionAug 2015
- Study completionAug 2015
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.
- Other trials for Diabetic NephropathyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 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
- NCT01774981
- Sponsor's protocol ID
- 14353
- Other IDs
- I5V-MC-TGAB, 2012-004496-40
- Status last verified
- Sep 2019
- First submitted
- 22 Jan 2013
- Last updated
- 19 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Safety and Efficacy of LY3016859 After Multiple Intravenous Dosing in Diabetic Nephropathy Patients
- ClinicalTrials.gov ID
- NCT01774981
- Acronym / sponsor ID
- 14353
- Conditions
- Diabetic Nephropathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2013
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 24 Jan 2013 (estimated)
- Results
- Posted 15 Aug 2017
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 two-part study is to investigate the safety, tolerability and efficacy of LY3016859 after multiple intravenous (IV) dosing's in participants with diabetic nephropathy (DN). Part A will be dose escalation for safety and tolerability and Part B will evaluate Proteinuria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Placebo (Part A) | Placebo comparator | Drug: PlaceboPart A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4. |
| 10 mg LY3016859 (Part A) | Experimental | Drug: LY3016859Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. |
| 100 mg LY3016859 (Part A) | Experimental | Drug: LY3016859Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. |
| 750 mg LY3016859 (Part A) | Experimental | Drug: LY3016859Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. |
| Placebo (Part B) | Placebo comparator | Drug: PlaceboPart B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. |
| 50 mg LY3016859 (Part B) | Experimental | Drug: LY3016859Part B: 50 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. |
| 250 mg LY3016859 (Part B) | Experimental | Drug: LY3016859Part B: 250 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. |
| 750 mg LY3016859 (Part B) | Experimental | Drug: LY3016859Part B: 750 mg LY3016859 administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Stable diabetic kidney disease (DKD) while taking Standard of Care medication (SOC), as defined by:
- Clinical chemistry labs within acceptable range for the participant population, as per investigator judgment
- Men and women of non-childbearing potential as determined by medical history and physical examination
- Must weigh ≥50 kilograms (kg) at time of screening and dosing
- Acceptable sitting blood pressure (BP) per the following American Heart Association (AHA) guidelines:
Key exclusion criteria (21 listed)
- Have a diagnosis of chronic kidney disease (CKD) other than DKD, (hypertensive nephrosclerosis superimposed on DKD is acceptable)
- Have SBP >160 mmHg or DBP >100 mmHg
- o Individuals with Stage 1 BP elevation (SBP 140-159 mmHg or DBP 90-99 mmHg) on some occasions during study, may be acceptable, as long as only non-protein-lowering antihypertensives are adjusted to achieve target BP goals (<140/90 mmHg)
- Current use of (or within 2 weeks of enrollment), or projected need for a renin inhibitor or aldosterone antagonist, or a combination of Angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (ACEi/ARB)
- Individuals in whom dialysis or transplantation is anticipated within 6 months of screening
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 |
|---|---|---|
| PlaceboAdministered IV | Drug | Placebo (Part A), Placebo (Part B) |
| LY3016859Administered IV | Drug | 10 mg LY3016859 (Part A), 100 mg LY3016859 (Part A), 250 mg LY3016859 (Part B), 50 mg LY3016859 (Part B), 750 mg LY3016859 (Part A), 750 mg LY3016859 (Part B) |
Primary outcome
Part B:Change From Baseline in Proteinuria
Time frame: Baseline, 16 Weeks
Proteinuria is defined as the ratio of protein to creatinine.
Part A and Part B: Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs
Time frame: Baseline up to 32 Weeks
Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section.
2 secondary outcomes
Part B: Change From Baseline in Proteinuria Over Time
Time frame: Baseline, 19 Weeks
Part B: Change From Baseline in Albuminuria Over Time
Time frame: Baseline, 19 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Related trials for Diabetic Nephropathy
Active, not recruitingObservational study
Family Investigation of Nephropathy and Diabetes (F.I.N.D.)
Diabetic Nephropathy, Diabetes Mellitus
Active, not recruitingPhase 4
Pentoxifylline in Diabetic Kidney Disease
Diabetic Kidney Disease
Not yet recruitingObservational study
Beta-2-Trace Protein in Diabetic Nephropathy
Diabetic Nephropathy Type 2, Type 2 Diabetes Mellitus
Active, not recruitingPhase 2
A Study on the Safety and Clinical Efficacy of Guominkang in the Treatment of Diabetic Kidney Disease
Diabetic Kidney Disease (DKD), Type 2 Diabetes
RecruitingPhase 2
Study to Assess the Effects of ALN-ANG3 in Adult Participants With Diabetic Kidney Disease
Diabetic Kidney Disease (DKD)
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
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LY3016859 in people with Diabetic Nephropathy, run by Eli Lilly and Company at 7 sites in 2 countries.
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 18 inclusion and 21 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 19 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Bulgaria. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 15 Aug 2017). 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?
Part B:Change From Baseline in Proteinuria (time frame: Baseline, 16 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2019; AzTrials last refreshed its copy on 7 Nov 2026.