Eloralintide for Obstructive Sleep Apnea

(ENLIGHTEN-3 Trial)

Not yet recruiting at 121 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 tests a new treatment called eloralintide for individuals with moderate-to-severe obstructive sleep apnea (a sleep disorder where breathing repeatedly stops and starts) who are also overweight or obese. The researchers aim to determine if eloralintide is safe and effective for these individuals. Participants will be divided into two groups: those not using Positive Airway Pressure (PAP) therapy and those who have used PAP therapy for at least three months. This trial suits individuals who have tried and failed to lose weight through diet and have a confirmed diagnosis of sleep apnea. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Do I need to stop taking my current medications for the trial?

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

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

Research has shown that eloralintide is generally well-tolerated. In earlier studies, participants reported only a few side effects, mostly mild ones like nausea or headaches, which usually resolved over time.

Eloralintide is also under study for potential use in treating obesity and sleep apnea. Other studies on similar treatments have found them safe for people with these conditions. Since this trial is in an advanced stage, earlier safety checks have shown promising results.

Overall, the data so far suggests that eloralintide is a safe option for those with sleep apnea and obesity. However, like any treatment, some individuals might experience side effects. It's important to discuss any concerns with the trial team.12345

Why do researchers think this study treatment might be promising for obstructive sleep apnea?

Most treatments for obstructive sleep apnea, like CPAP machines and oral appliances, work by physically keeping airways open during sleep. But Eloralintide offers a fresh approach by being delivered subcutaneously (under the skin) and potentially working internally to address the root cause of airway obstruction. This new method could make it easier for people who struggle with the bulkiness or discomfort of traditional devices. Researchers are excited because Eloralintide might provide a more convenient and less intrusive option, encouraging better patient adherence and effectiveness.

What evidence suggests that this trial's treatments could be effective for obstructive sleep apnea?

Research has shown that eloralintide may benefit people with moderate-to-severe obstructive sleep apnea, particularly those who are overweight or obese. Studies suggest that this drug might improve sleep apnea by reducing the frequency of breathing interruptions during sleep. Some early findings indicate that eloralintide can decrease sleep disruptions, leading to better sleep quality. Although detailed information on its effectiveness remains limited, these initial results offer hope. This trial will test eloralintide in different formulations, presenting a promising option for those who struggle with current treatments like Positive Airway Pressure (PAP) therapy.13467

Who Is on the Research Team?

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Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for adults with moderate-to-severe obstructive sleep apnea and obesity or overweight. Participants must have a BMI of at least 27, stable weight in the last 90 days, and either be using PAP therapy for over three months or be unable to use it. They should also have tried dieting without success.

Inclusion Criteria

I have been diagnosed with moderate-to-severe sleep apnea.
My sleep study shows I have moderate to severe sleep apnea.
My BMI is 27 or higher.
See 4 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 the duration of the study

72 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Eloralintide

Trial Overview

The study tests Eloralintide's effectiveness and safety in treating sleep apnea combined with obesity. It includes two groups: one taking Eloralintide and another receiving a placebo. The trial lasts about 76 weeks, with participants grouped based on their PAP therapy usage.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Eloralintide (YSA2)Experimental Treatment1 Intervention
Group II: Eloralintide (YSA1)Experimental Treatment1 Intervention
Group III: Placebo (YSA1)Placebo Group1 Intervention
Group IV: Placebo (YSA2)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

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