Eloralintide for Osteoarthritis
(ENLIGHTEN-4 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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Eloralintide or placebo subcutaneously for osteoarthritis knee pain and obesity or overweight
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
Participants will receive eloralintide SC
Participants will receive eloralintide subcutaneously (SC)
Participants will receive placebo SC
Participants will receive placebo SC
Find a Clinic Near You
Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Dr. Daniel Skovronsky
Eli Lilly and Company
Chief Medical Officer since 2018
MD from Harvard Medical School
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 ...
4.
ctv.veeva.com
ctv.veeva.com/study/efficacy-and-safety-of-eloralintide-ly3841136-in-participants-with-osteoarthritis-knee-pain-and-obEfficacy 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 ...
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