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Also known as LY3016859 intravenous, LY3016859 ISA
LY3016859 · 5 trials · 6 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.
| 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. |
| LY3016859 Osteoarthritis ISA | EXPERIMENTAL | Participants are randomized to receive either active LY3016859 or matching placebo |
| LY3016859 Diabetic Neuropathic Pain ISA | EXPERIMENTAL | Participants are randomized to receive either active LY3016859 or matching placebo |
| LY3016859 Chronic Back Pain ISA | EXPERIMENTAL | Participants are randomized to receive either active LY3016859 or matching placebo |
| LY3556050 Osteoarthritis ISA | EXPERIMENTAL | Participants are randomized to receive either active LY3556050 or matching placebo |
| LY3556050 Diabetic Neuropathic Pain ISA | EXPERIMENTAL | Participants are randomized to receive either active LY3556050 or matching placebo |
| LY3556050 Chronic Back Pain ISA | EXPERIMENTAL | Participants are randomized to receive either active LY3556050 or matching placebo |
| LY3526318 Osteoarthritis ISA | EXPERIMENTAL | Participants are randomized to receive either active LY3526318 or matching placebo |
| LY3526318 Diabetic Neuropathic Pain ISA | EXPERIMENTAL | Participants are randomized to receive either active LY3526318 or matching placebo |
| LY3526318 Chronic Back Pain ISA | EXPERIMENTAL | Participants are randomized to receive either active LY3526318 or matching placebo |
| LY3857210 Osteoarthritis ISA | EXPERIMENTAL | Participants are randomized to receive either active LY3857210 or matching placebo |
| LY3857210 Diabetic Neuropathic Pain ISA | EXPERIMENTAL | Participants are randomized to receive either active LY3857210 or matching placebo |
| LY3857210 Chronic Back Pain ISA | EXPERIMENTAL | Participants are randomized to receive either active LY3857210 or matching placebo |
| LY4065967 Chronic Low Back Pain ISA | EXPERIMENTAL | Participants are randomized to receive either active LY4065967 or matching placebo |
| LY4065967 Osteoarthritis ISA | EXPERIMENTAL | Participants are randomized to receive either active LY4065967 or matching placebo |
| LY4065967 Diabetic Neuropathic Pain ISA | EXPERIMENTAL | Participants are randomized to receive either active LY4065967 or matching placebo |
| 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. |
| Name | Type | Description |
|---|---|---|
| LY3016859 | DRUG | Administered IV |
| Placebo | DRUG | Administered IV |
| LY3016859 ISA | DRUG | Administered intravenously (IV) |
| LY3556050 ISA | DRUG | Administered orally |
| LY3526318 ISA | DRUG | Administered orally |
| LY3857210 ISA | DRUG | Administered orally |
| Placebo Oral | DRUG | Placebo administered orally |
| LY4065967 ISA | DRUG | Administered orally |
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 ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GSK plc Sponsored ADR | GSK | 2 | PHASE3 | Camlipixant |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE2 | Haduvio (nalbuphine ER) |
LY3016859 is an investigational medicine being studied for chronic pain conditions. Eli Lilly and Company is evaluating it in chronic low-back pain, diabetic peripheral neuropathic pain, and osteoarthritis, including osteoarthritis of the knee. It is not approved for any use and remains in clinical development.
LY3016859 is being developed by Eli Lilly and Company, which trades on the New York Stock Exchange under the ticker LLY. Lilly is running the clinical program, including a chronic pain master protocol that tests the drug across several pain indications.
LY3016859 is in Phase 2 clinical development. It has been studied in completed Phase 2 trials in chronic low-back pain, diabetic peripheral neuropathic pain, and osteoarthritis, and it continues to be evaluated in a recruiting Phase 2 master protocol in chronic pain.
LY3016859 has been tested in three completed Phase 2 trials: NCT04529096 in chronic low-back pain, NCT04476108 in diabetic peripheral neuropathic pain, and NCT04456686 in osteoarthritis. It is also included in the recruiting master protocol NCT05986292, which covers knee osteoarthritis, diabetic neuropathic pain, and chronic low-back pain.
Yes. LY3016859 intravenous and LY3016859 ISA refer to the same investigational compound as LY3016859. ISA stands for intervention-specific appendix, the substudy structure used in Lilly's chronic pain master protocol, and intravenous describes the route of administration.
No. LY3016859 is an investigational drug and is not approved by the FDA. It is still in Phase 2 clinical development for chronic pain conditions, including chronic low-back pain, diabetic peripheral neuropathic pain, and osteoarthritis.