Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LY3016859 · 5 trials · 5 indications
The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval (CrI) was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals
The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval (CrI) was derived using Bayesian mixed model repeated measures.
The NRS was used during the preliminary data entry period and daily throughout the study to describe pain severity. Participants were asked to describe their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine. Posterior mean change from baseline, 95% credible interval (CrI) was derived using Bayesian mixed model repeated measures. The Bayesian analyses include posterior probabilities instead of p-values, and 95% credible intervals instead of 95% confidence intervals.
Proteinuria is defined as the ratio of protein to creatinine.
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.
Drug-related TEAEs are any untoward medical occurrence that either occurs or worsens at any time after treatment baseline, and in the opinion of the investigators is possibly related to study drug. A summary of SAEs and other nonserious AEs, regardless of whether or not they were possibly related to study drug, is located in the Reported Adverse Event section.
| Arm | Type | Description |
|---|---|---|
| 750 Mg-500 mg LY3016859 | EXPERIMENTAL | Participants received LY3016859 every 2 weeks with 750 milligram (mg) as starting dose followed by 500 mg intravenous (IV) infusion for a total of 4 doses |
| Placebo | PLACEBO_COMPARATOR | Participants received placebo every 2 weeks by IV infusion for a total of 4 doses. |
| Placebo (Part A) | PLACEBO_COMPARATOR | Part A: Placebo administered by 60 minute Intravenous (IV) infusion at Week 1 and Week 4. |
| 10 mg LY3016859 (Part A) | EXPERIMENTAL | Part A: 10 milligram (mg) LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. |
| 100 mg LY3016859 (Part A) | EXPERIMENTAL | Part A: 100 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. |
| 750 mg LY3016859 (Part A) | EXPERIMENTAL | Part A: 750 mg LY3016859 administered by 60 minute IV infusion at Week 1 and Week 4. |
| Placebo (Part B) | PLACEBO_COMPARATOR | Part B: Placebo administered by 60 minute IV infusion at Weeks 1, 4, 7, 10 and 13. |
| 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. |
| 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. |
| 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. |
| Placebo intravenous | PLACEBO_COMPARATOR | Placebo administered once intravenously |
| 0.1 milligram (mg) LY3016859 intravenous | EXPERIMENTAL | 0.1 mg LY3016859 administered once intravenously |
| 1 mg LY3016859 intravenous | EXPERIMENTAL | 1 mg LY3016859 administered once intravenously |
| 10 mg LY3016859 intravenous | EXPERIMENTAL | 10 mg LY3016859 administered once intravenously |
| 50 mg LY3016859 intravenous | EXPERIMENTAL | 50 mg LY3016859 administered once intravenously |
| 250 mg LY3016859 intravenous | EXPERIMENTAL | 250 mg LY3016859 administered once intravenously |
| 750 mg LY3016859 intravenous | EXPERIMENTAL | 750 mg LY3016859 administered once intravenously |
| Placebo subcutaneous | PLACEBO_COMPARATOR | Placebo administered once subcutaneously |
| 50 mg LY3016859 subcutaneous | EXPERIMENTAL | 50 mg LY3016859 administered once subcutaneously |
| Name | Type | Description |
|---|---|---|
| LY3016859 | DRUG | Administered IV |
| Placebo | DRUG | Administered IV |
| LY3016859 intravenous | DRUG | Administered intravenously |
| Placebo intravenous | DRUG | Administered intravenously |
| LY3016859 subcutaneous | DRUG | Administered subcutaneously |
| Placebo subcutaneous | DRUG | Administered subcutaneously |
Inclusion Criteria: * Have a visual analog scale (VAS) pain value ≥40 and \<95 during screening. * Have a history of daily pain for at least 12 weeks based on participant report or medical history. * Have a value of ≤30 on the pain catastrophizing scale. * Have a body mass index \<40 kilograms per ...
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LY3016859 is an investigational small molecule being studied for pain-related conditions, including osteoarthritis, chronic low-back pain, diabetic peripheral neuropathic pain, and diabetic nephropathy. It has also been evaluated in healthy volunteers. The drug is being developed by Eli Lilly and Company and has reached Phase 2 clinical trials.
LY3016859 is being developed by Eli Lilly and Company, a pharmaceutical company traded on the NYSE under the ticker LLY. The drug is an investigational small molecule in clinical development for pain indications, including osteoarthritis and chronic low-back pain.
LY3016859 is in Phase 2 clinical development. It has completed Phase 1 testing in healthy volunteers and Phase 2 studies in patients with osteoarthritis, diabetic peripheral neuropathic pain, and chronic low-back pain. The drug is investigational and not yet approved by regulatory authorities.
LY3016859 has been studied in several completed trials. NCT01545583 was a Phase 1 study in healthy volunteers in the United Kingdom. NCT04456686, NCT04476108, and NCT04529096 were Phase 2 trials under the Chronic Pain Master Protocol, conducted in the United States and Puerto Rico for osteoarthritis, diabetic peripheral neuropathic pain, and chronic low-back pain, respectively.
Yes, LY3016859 is listed as being studied for diabetic nephropathy, in addition to pain conditions. However, the completed clinical trials for LY3016859 include studies in healthy volunteers, osteoarthritis, diabetic peripheral neuropathic pain, and chronic low-back pain. The drug remains in clinical development.