mazisotine (LY3556050) / Eli Lilly, Centrexion Therap - LARVOL DELTA

A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2 | N=410 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Jan 2025 ➔ Jul 2025 | Trial primary completion date: Jan 2025 ➔ Jul 2025

Trial completion date • Trial primary completion date • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Phase 2 studies evaluating LY3556050, a SSTR4 agonist, for osteoarthritis and chronic low back pain (IASP 2024) - P2 | "In both studies, there was no statistical evidence that LY3556050 600 mg BID was superior to placebo in relieving OA pain in the knee or CLBP. The overall safety profile was generally consistent for both studies. Most common TEAEs were constipation, nausea, dizziness, fatigue, and headache; most were mild to moderate."

P2 data • Back Pain • Constipation • Fatigue • Gastroenterology • Gastrointestinal Disorder • Immunology • Lumbar Back Pain • Musculoskeletal Pain • Oncology • Osteoarthritis • Osteosarcoma • Pain • Rheumatology • Sarcoma • Solid Tumor

A phase 2 study evaluating SSTR4 agonist, LY3556050, for diabetic peripheral neuropathic pain (IASP 2024) - P2 | "Metformin doses were limited to ?1000 mg/day (due to a drug-drug interaction). In this study, treatment with LY3556050 600 mg BID in participants with DPNP was associated with improvement in pain, as demonstrated by a statistically significant improvement in mean change in API from baseline at Week 8 vs placebo and some secondary measures. Furthermore, effectiveness of LY3556050 was demonstrated by Week 2 and was sustained till the end of study. Treatment-emergent AEs due to LY3556050 were mild to moderate in severity."

P2 data • Constipation • Diabetes • Diabetic Neuropathy • Gastroenterology • Gastrointestinal Disorder • Metabolic Disorders • Neuralgia • Pain • Peripheral Neuropathic Pain • Type 1 Diabetes Mellitus

Operational Benefits of the Chronic Pain Master Protocol Platform Trial (IASP 2024) - "It assessed safety and efficacy of 4 potential novel chronic pain interventions (LY3016859 Epiregulin/TGF? monoclonal antibody, LY3526318 transient receptor potential ankyrin 1 antagonist, LY3556050 somatostatin receptor 4 antagonist and LY3857210 purinergic 2X7 antagonist) vs placebo in patients with osteoarthritis of the knee, chronic low back pain and diabetic peripheral neuropathic pain... The CPMP design enables efficient testing of multiple investigational interventions across a variety of pain types while allowing study interventions to be added at different time points across patient populations. At the same time, the use of standardized design elements and dedicated resources within the overall context of this flexible design resulted in reduced enrollment timelines and operational efficiencies at several levels."

Clinical • Back Pain • Diabetic Neuropathy • Immunology • Lumbar Back Pain • Musculoskeletal Pain • Neuralgia • Osteoarthritis • Pain • Peripheral Neuropathic Pain • Rheumatology • EREG • SSTR

A Study of Carbon-14-Labelled [14C] LY3556050 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=7 | Completed | Sponsor: Eli Lilly and Company | Recruiting ➔ Completed

Trial completion

A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2 | N=410 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

A Study of LY3556050 in Adult Participants With Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2 | N=410 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

A Study of Carbon-14-Labelled [14C] LY3556050 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=7 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open

A Study of Carbon-14-Labelled [14C] LY3556050 in Healthy Male Participants (clinicaltrials.gov) - P1 | N=7 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P1 trial

CPMP: A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain (clinicaltrials.gov) - P2 | N=10000 | Recruiting | Sponsor: Eli Lilly and Company

New P2 trial • Back Pain • Diabetic Neuropathy • Immunology • Lumbar Back Pain • Musculoskeletal Pain • Neuralgia • Osteoarthritis • Pain • Rheumatology

A Study of Effect of LY3556050 on Metformin in Healthy Participants (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion

A Study of Effect of LY3556050 on Metformin in Healthy Participants (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Eli Lilly and Company | Recruiting ➔ Active, not recruiting

Enrollment closed

A Study of Effect of LY3556050 on Metformin in Healthy Participants (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open

A Study of Effect of LY3556050 on Metformin in Healthy Participants (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Eli Lilly and Company

New P1 trial

Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2 | N=69 | Terminated | Sponsor: Eli Lilly and Company | Completed ➔ Terminated; The trial was slow to enroll, and the sponsor made a business decision to terminate the trial earlier than planned.

Trial termination • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2 | N=69 | Completed | Sponsor: Eli Lilly and Company | Recruiting ➔ Completed | N=150 ➔ 69 | Trial completion date: May 2023 ➔ Jun 2022 | Trial primary completion date: May 2023 ➔ Jun 2022

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

A Study of Single and Repeated Doses of LY3556050 in Healthy Participants (clinicaltrials.gov) - P1 | N=106 | Completed | Sponsor: Eli Lilly and Company

New P1 trial

Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2 | N=150 | Recruiting | Sponsor: Eli Lilly and Company | Trial completion date: Feb 2024 ➔ May 2023 | Trial primary completion date: Feb 2024 ➔ May 2023

Trial completion date • Trial primary completion date • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Chronic Low Back Pain (clinicaltrials.gov) - P2 | N=153 | Completed | Sponsor: Eli Lilly and Company | Recruiting ➔ Completed

Trial completion • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Osteoarthritis (clinicaltrials.gov) - P2; N=202; Completed; Sponsor: Eli Lilly and Company; Recruiting ➔ Completed

Clinical • Trial completion • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Eli Lilly and Company; Trial completion date: Apr 2022 ➔ Feb 2024; Trial primary completion date: Apr 2022 ➔ Feb 2024

Clinical • Trial completion date • Trial primary completion date • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Chronic Low Back Pain (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Eli Lilly and Company; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Diabetic Peripheral Neuropathic Pain (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Eli Lilly and Company; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Diabetic Neuropathy • Neuralgia • Pain • Peripheral Neuropathic Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Chronic Low Back Pain (clinicaltrials.gov) - P2; N=200; Not yet recruiting; Sponsor: Eli Lilly and Company

Clinical • New P2 trial • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

Chronic Pain Master Protocol (CPMP): A Study of LY3556050 in Participants With Osteoarthritis (clinicaltrials.gov) - P2; N=200; Recruiting; Sponsor: Eli Lilly and Company; Trial completion date: Jul 2021 ➔ Dec 2021; Trial primary completion date: Jul 2021 ➔ Dec 2021

Clinical • Trial completion date • Trial primary completion date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology