Phase 2
N=60
Study of LY3016859 in Participants With Diabetic Nephropathy
Diabetic Nephropathy
Bottom Line
View on ClinicalTrials.gov: NCT01774981 ↗Enrolled (actual)
60
Serious AEs
20.0%
Results posted
Aug 2017
Primary outcome: Primary: Part B:Change From Baseline in Proteinuria — 1.5; -0.4; 0.1; 0.7 grams per 12 hour (g/12 hour) — p=0.0449
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); LY3016859 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eli Lilly and Company
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Part B:Change From Baseline in Proteinuria |
1.5; -0.4; 0.1; 0.7 | 0.0449 sig |
| PRIMARY Part A and Part B: Number of Participants With One or More Treatment Emergent Adverse Events (AEs) or Any Serious AEs |
1; 3; 4; 2; 6; 13 | — |
| SECONDARY Part B: Change From Baseline in Proteinuria Over Time |
19.3; -17.3; -2.4; 48.6 | — |
| SECONDARY Part B: Change From Baseline in Albuminuria Over Time |
8.6; -15.6; -8.1; 36.7 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Stable diabetic kidney disease (DKD) while taking Standard of Care medication (SOC), as defined by:
- Estimated glomerular filtration rate (eGFR) less 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) 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 ( 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
Data sourced from ClinicalTrials.gov (NCT01774981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.