Eloralintide for Obesity

(ENLIGHTEN-1 Trial)

Not yet recruiting at 171 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must not be taking: Weight loss medications

Disqualifiers: Type 1 diabetes, Type 2 diabetes, Recent heart attack, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called eloralintide to determine if it can safely aid weight loss. It targets adults who struggle with obesity or are overweight but do not have type 2 diabetes. Participants will be divided into groups to receive either various doses of eloralintide or a placebo (inactive substance). The trial suits those with a history of unsuccessful diet attempts, a stable weight, and certain weight-related health conditions like high blood pressure or sleep apnea. Participants with prediabetes may continue in the trial for an additional two years to observe long-term effects. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but 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 has shown that eloralintide was well-tolerated in earlier studies. One study found that after 48 weeks, participants using eloralintide experienced significant weight loss without major safety issues. This treatment mimics a natural hormone in the body to help manage weight. Some people reported mild side effects like nausea, but it was generally considered safe. As this study is in a late phase, eloralintide has already been found safe in earlier trials and is now being monitored closely for any rare side effects. ^{1 2 3 4 5}

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

Unlike current obesity treatments, which often involve lifestyle changes, medications like orlistat, or GLP-1 receptor agonists such as semaglutide, eloralintide introduces a new approach. This investigational drug is administered subcutaneously and may offer a unique mechanism of action that differs from existing therapies. Researchers are excited about eloralintide's potential to provide effective weight management with possibly fewer side effects or improved patient outcomes compared to the standard treatments available today.

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

Research has shown that eloralintide can aid in weight loss. In earlier studies, participants taking eloralintide lost between 9.5% and 20.1% of their body weight after 48 weeks, compared to only about 0.4% for those taking a placebo (a fake treatment). In this trial, participants will receive different doses of eloralintide or a placebo. Eloralintide works by affecting a part of the brain that controls hunger and appetite. These results suggest that eloralintide could be a promising option for weight loss in adults who are overweight or have obesity. ^{1 5 6 7 8}

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 with obesity or overweight but without type 2 diabetes. It's not clear what specific inclusion criteria are required, nor the exclusion criteria that would prevent someone from participating.

Inclusion Criteria

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

Have Body Mass Index (BMI) at screening of 30 kg/m2 OR 27 kg/m2 with at least one of the following weight-related health conditions at screening: high blood pressure, dyslipidemia, obstructive sleep apnea, or heart disease

Have a history of at least one self-reported unsuccessful dietary effort to reduce body weight

Exclusion Criteria

I have severe heart failure.

I have had or plan to have surgery for obesity more than a year ago.

I have had or am planning to have a procedure or device-based therapy for obesity.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Main Treatment

Participants receive eloralintide or placebo subcutaneously for the main phase

75 weeks

Extension

Participants with prediabetes continue treatment in the extension phase

2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Eloralintide

Trial Overview

The study tests eloralintide against a placebo to see if it's effective and safe in treating obesity in adults. The trial includes a main phase of about 75 weeks, followed by an extension phase lasting two more years for those with prediabetes.

How Is the Trial Designed?

Group I: Eloralintide Dose 4 Experimental Treatment 1 Intervention

Participants will receive eloralintide SC

Group II: Eloralintide Dose 3 Experimental Treatment 1 Intervention

Participants will receive eloralintide SC

Group III: Eloralintide Dose 2 Experimental Treatment 1 Intervention

Participants will receive eloralintide SC

Group IV: Eloralintide Dose 1 Experimental Treatment 1 Intervention

Participants will receive eloralintide subcutaneously (SC)

Group V: Placebo Placebo Group 1 Intervention

Participants will receive placebo SC

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

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

1.

lilly.gcs-web.com

lilly.gcs-web.com/news-releases/news-release-details/lillys-selective-amylin-agonist-eloralintide-demonstrated

Lilly's selective amylin agonist, eloralintide, demonstrated ...

At 48 weeks, all treatment arms of eloralintide met the primary endpoint, demonstrating superior mean weight reductions from 9.5% to 20.1% ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41207310/

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

Interpretation: Eloralintide produced clinically meaningful, dose-dependent reductions in bodyweight over 48 weeks and was generally well ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07321886

A Study of Eloralintide (LY3841136) in Participants With ...

The purpose of this study is to evaluate the efficacy and safety of eloralintide in adults with obesity or overweight who do not have type 2 ...

4.

appliedclinicaltrialsonline.com

appliedclinicaltrialsonline.com/view/eli-lilly-trial-eloralintide-weight-reduction-adults-obesity

Eli Lilly's Phase II Trial of Eloralintide Shows Up to 20 ...

Mean weight loss ranged from 9% at the lowest dose to 20% at 9 mg after 48 weeks. Placebo group saw a 0.4% mean reduction in body weight.

5.

prnewswire.com

prnewswire.com/news-releases/lillys-selective-amylin-agonist-eloralintide-demonstrated-meaningful-weight-loss-and-favorable-tolerability-in-a-phase-2-study-of-adults-with-obesity-or-overweight-302607061.html

Lilly's selective amylin agonist, eloralintide, demonstrated ...

At 48 weeks, all treatment arms of eloralintide met the primary endpoint, demonstrating superior mean weight reductions from 9.5% to 20.1% ...

6.

trials.lilly.com

trials.lilly.com/en-US/trial/673735

A Study of Eloralintide (LY3841136) in Participants With ...

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo for body weight reduction in participants with ...

7.

thelancet.com

thelancet.com/journals/lancet/article/PIIS0140-6736(25)02155-5/abstract

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

Eloralintide is a novel, selective amylin receptor agonist in development for weight management. We performed a phase 2, double blind, ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12640043/

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

Eloralintide (LY3841136), a novel amylin analog, was evaluated in translational studies to characterize its therapeutic potential for treating obesity.