Eloralintide for Osteoarthritis

(ENLIGHTEN-4 Trial)

Not yet recruiting at 151 trial locations
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Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eli Lilly and Company
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of 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.

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults over 50 with obesity or overweight (BMI of 27 kg/m² or higher) who have osteoarthritis knee pain. Participants should have tried dieting to lose weight unsuccessfully and must not have had significant weight changes in the last 90 days. They should experience morning knee stiffness lasting around 30 minutes and a crackling sensation in the knee.

Inclusion Criteria

My knee stiffness in the morning lasts about 30 minutes.
My BMI is 27 or higher.
My weight has been stable, with less than a 5% change, for the last 3 months.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Eloralintide or placebo subcutaneously for osteoarthritis knee pain and obesity or overweight

64 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Eloralintide

Trial Overview

The study tests Eloralintide's effectiveness and safety for those with obesity/overweight and osteoarthritis knee pain. It compares Eloralintide against a placebo over approximately 75 weeks, including initial screening, to determine its impact on managing OA symptoms.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Eloralintide (YOA2)Experimental Treatment1 Intervention
Group II: Eloralintide (YOA1)Experimental Treatment1 Intervention
Group III: Placebo (YOA1)Placebo Group1 Intervention
Group IV: Placebo (YOA2)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University