Health TrialsbyHealthPanel

A Chronic Pain Master Protocol (CPMP): A Study of LY4065967 in Participants With Osteoarthritis Pain

ConditionsOsteoarthritis, KneeChronic Pain
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorEli Lilly and Company

About this trial

The main purpose of this study is to test the safety and efficacy of study drug for the treatment of knee pain due to osteoarthritis (OA). 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have presence of index knee pain for more than 12 weeks at screening

Have an x-ray supporting diagnosis of osteoarthritis according to the American College of Rheumatology with a Kellgren-Lawrence grade 2 to 4 radiographic classification of index knee

Have a body mass index ≤40 kilograms per meter squared (kg/m²) (inclusive)

Have stable glycemic control as indicated by a glycated hemoglobin (HbA1c) less than or equal to 10 at time of screening

Disqualifiers

Are pregnant or breastfeeding

Have had a surgical procedure or therapeutic injection in the affected knee within 3 months prior to screening

Have presence of surgical hardware or other foreign body in the index knee

Have ongoing complex regional pain syndrome or other concurrent medical condition that could interfere with the evaluation of pain in the index knee.

Trial design

Design model

Parallel

Treatments tested in this trial

  • LY4065967

    Drug

    Administered orally

  • Placebo

    Drug

    Administered orally

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: LY4065967Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline in Average Pain Intensity as Measured by the Numeric Rating Scale (NRS)

Time frame
Baseline, Week 8

Secondary outcomes

1

Change From Baseline in the Western Ontario and McMaster University Arthritis Index (WOMAC®) Pain Subscale

Time frame
Baseline, week 8
2

Change From Baseline in Overall Improvement as Measured by Patient's Global Impression of Change

Time frame
Baseline, Week 8
3

Change From Baseline for Worst Pain Intensity as Measured by NRS

Time frame
Baseline, Week 8
4

Change From Baseline in the Sleep Scale from the Medical Outcomes Study (MOS Sleep Scale)

Time frame
Baseline, Week 8

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eli Lilly and Company

Lead sponsor

Source ClinicalTrials.gov
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