Eloralintide for Osteoarthritis

(ENLIGHTEN-4 Trial)

Not yet recruiting at 155 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?

This trial explores the effectiveness and safety of Eloralintide for individuals who are overweight or obese and suffer from knee osteoarthritis with pain. Participants will receive either Eloralintide or a placebo (a substance with no active drug) to compare effects. It is ideal for those with a BMI of 27 or higher who have struggled to lose weight and experience knee issues such as morning stiffness or a crackling sound. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, you cannot have taken any weight loss medications or remedies in the 90 days before screening.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that Eloralintide has been tested in earlier human studies. Researchers closely monitored the safety of Eloralintide and carefully noted any unwanted side effects. Most participants handled the treatment well. Common side effects included mild reactions at the injection site and some cases of nausea. Serious side effects were not commonly reported, suggesting that Eloralintide is generally well-tolerated. This information provides a positive view of the safety of Eloralintide for those considering joining a clinical trial.12345

Why do researchers think this study treatment might be promising for osteoarthritis?

Eloralintide is unique because it brings a fresh approach to treating osteoarthritis by being administered subcutaneously, which might offer more targeted relief. Current standard treatments often involve oral medications like NSAIDs or corticosteroid injections. Unlike these, Eloralintide's subcutaneous delivery could potentially reduce systemic side effects and provide more localized action. Researchers are excited about Eloralintide because it may offer a novel mechanism of action that specifically targets the inflammatory processes in osteoarthritis, paving the way for more effective symptom management.

What evidence suggests that this trial's treatments could be effective for osteoarthritis?

Research shows that Eloralintide, a medication targeting specific receptors, may help reduce knee pain in people with osteoarthritis (OA) who are overweight or obese. Previous studies found that Eloralintide led to significant weight loss, with participants losing up to 11% of their body weight after 12 weeks of treatment. This weight loss likely reduces stress on the knees, potentially easing OA pain. Although direct evidence on pain reduction in OA is limited, the promising weight loss effects suggest potential benefits for knee health. Early findings support further research into its effectiveness for relieving osteoarthritis pain. Participants in this trial will receive either Eloralintide or a placebo to evaluate its impact on OA symptoms.12356

Who Is on the Research Team?

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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.
See 3 more

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

Citations

Efficacy and Safety of Eloralintide (LY3841136) in ...

Each study will investigate how well and safely Eloralintide (LY3841136) works in adults with obesity or overweight who have osteoarthritis (OA) of the knee ...

Eloralintide for Osteoarthritis · Info for Participants

The study tests Eloralintide's effectiveness and safety for those with obesity/overweight and osteoarthritis knee pain. It compares Eloralintide ...

Eloralintide, a selective amylin receptor agonist for the ...

Phase 1 clinical trials showed that once-per-week dosing produced an up to 11% bodyweight reduction after 12 weeks of exposure, with generally ...

Efficacy and Safety of Eloralintide (LY3841136) in Participants ...

Each study will investigate how well and safely Eloralintide (LY3841136) works in adults with obesity or overweight who have osteoarthritis (OA) ...

Completed Trials - Lilly Trials

The purpose of this study is to test safety or efficacy of study drug LY3526318 in participants with osteoarthritis (OA) knee pain. This trial is part of the ...

Eloralintide (LY3841136), a novel amylin receptor agonist ...

In the clinical trial, descriptive statistics were used to summarize demographic data, adverse events, and safety data. Plasma concentrations of ...