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Efficacy and Safety of Eloralintide (LY3841136) in Participants With Osteoarthritis Knee Pain and Obesity or Overweight

ConditionsOsteoarthritisOverweight or Obesity
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorEli Lilly and Company

About this trial

The YDAN master protocol will support two independent studies, J3R-MC-YOA1 and J3R-MC-YOA2. Each study will investigate how well and safely Eloralintide (LY3841136) works in adults with obesity or overweight who have osteoarthritis (OA) of the knee with pain. Participation in the study will last about 75 weeks, including screening.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have a body mass index (BMI) of 27 kilograms per square meter (kg/m²) or higher at screening

Have a stable body weight (less than 5% body weight change) for 90 days prior to screening

Have tried at least once to lose weight through diet but were unsuccessful

Be over 50 years old

Disqualifiers

Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed greater than 1 year before screening)

Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)

Have type 1 diabetes, type 2 diabetes, or any other type of diabetes

Have an active knee infection

Trial design

Design model

Parallel

Treatments tested in this trial

  • Eloralintide

    Drug

    Administered SC

  • Placebo

    Drug

    Placebo administered SC

Treatment groups

900 Participants
are divided into 4 treatment groups
Group A: Eloralintide (YOA1)Experimental treatment 1 intervention
Group B: Placebo (YOA1)Placebo comparator 1 intervention
Group C: Eloralintide (YOA2)Experimental treatment 1 intervention
Group D: Placebo (YOA2)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Percent Change from Baseline in Body Weight

Percent Change from Baseline in Body Weight

Time frame
Baseline, Week 64
2

Change from Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Score

Change from Baseline in the WOMAC Pain Subscale Score

Time frame
Baseline, Week 64

Secondary outcomes

1

Change from Baseline in Systolic Blood Pressure (SBP)

Change from Baseline in SBP

Time frame
Baseline, Week 64
2

Percent Change from Baseline in Triglycerides

Percent Change in Baseline in Triglycerides

Time frame
Baseline, Week 64
3

Change from Baseline in Short Form-36 (SF-36 v2) Acute Form Physical Functioning Domain Score

Change from Baseline in SF-36 v2 Score

Time frame
Baseline, Week 64
4

Percent Change from Baseline in High Sensitivity, C-reactive Protein (hsCRP)

Percent Change from Baseline in hsCRP

Time frame
Baseline, Week 64

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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