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NCT05620576 · ClinicalTrials.gov registry record · Phase 2

A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05).

A Phase 2 study of Diabetic Peripheral Neuropathic Pain, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 2
Development phase
131
Enrollment target
20
Study locations

NCT05620576: Completed Phase 2 study of Diabetic Peripheral Neuropathic Pain, sponsored by Eli Lilly and Company.

NCT05620576 is a Phase 2 study of Diabetic Peripheral Neuropathic Pain that has completed, run by Eli Lilly and Company. The registered enrollment target is 131 participants, below the 419-participant average among 7 other Diabetic Peripheral Neuropathic Pain trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05620576, a Phase 2 study of Diabetic Peripheral Neuropathic Pain, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 2
Development phase
131 participants
Enrollment target
20
Study locations

Study Summary

This study is being done to test the safety and efficacy of the study drug LY3857210 for the treatment of diabetic peripheral neuropathic pain. This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chronic pain.

Primary Outcome

The NRS was used 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 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented are posterior mean with 95% credible interval.

Interventions

  • DRUG Placebo
  • DRUG LY3857210

Study Locations (20)

Florida

  • Accel Research Sites- Clinical Research Unit - DeLand
  • Suncoast Research Group - Miami
  • University of Miami Don Suffer Clinical Research Building - Miami
  • New Horizon Research Center - Miami
  • Renstar Medical Research - Ocala
  • Synexus Clinical Research US, Inc - Orlando - Orlando
  • Synexus Clinical Research US, Inc. - Pinellas Park

Massachusetts

  • Boston Clinical Trials - Boston
  • ActivMed Practices and Research - Methuen
  • MedVadis Research Corporation - Waltham

Arizona

  • Synexus Clinical Research US, Inc. - Chandler
  • Arizona Research Center - Phoenix

California

  • Artemis Institute for Clinical Research - Riverside
  • Artemis Institute for Clinical Research - San Diego

Connecticut

  • CMR of Greater New Haven, LLC - Hamden

Georgia

  • North Georgia Clinical Research - Woodstock

Idaho

  • Rocky Mountain Clinical Research - Idaho Falls

Illinois

  • Northwestern University - Chicago

Trial Details

FieldValue
Enrollment Target 131 participants
Start Date 2022-11-14
Est. Completion 2023-08-01
Phase Phase 2
Eli Lilly and Company

1,341 total trials

What the finished NCT05620576 record still lists

NCT05620576 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 419-participant average among 7 other Diabetic Peripheral Neuropathic Pain trials with a reported enrollment target (69% lower).

The record links to 1 condition, with Diabetic Peripheral Neuropathic Pain appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05620576 names 20 study sites across 10 states, led by Florida, Massachusetts, Arizona.

Frequently Asked Questions

What is clinical trial NCT05620576 about?

NCT05620576 is a clinical study titled "A Chronic Pain Master Protocol (CPMP): A Study of LY3857210 in Participants With Diabetic Peripheral Neuropathic Pain (NP05).". This study is being done to test the safety and efficacy of the study drug LY3857210 for the treatment of diabetic peripheral neuropathic pain. This trial is part of the chronic pain master protocol H0P-MC-CPMP (NCT05986292) which is a protocol to accelerate the development of new treatments for chr...

What is the current status of trial NCT05620576?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 131 participants. The study started on 2022-11-14. Estimated completion is 2023-08-01.

What conditions does trial NCT05620576 study?

This clinical trial studies the following conditions: Diabetic Peripheral Neuropathic Pain.

What interventions are being tested in trial NCT05620576?

The interventions under investigation include: Placebo (DRUG), LY3857210 (DRUG).

Who is sponsoring clinical trial NCT05620576?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05620576 being conducted?

This trial has 20 study locations across Arizona, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Source: ClinicalTrials.gov NCT05620576, the US trial registry maintained by the National Library of Medicine. NCT05620576 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.