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?

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 diabetes. The study has two phases: a main phase and an extension phase.

Participation in the main phase of the study will last about 75 weeks. Participants with prediabetes will continue in the extension phase for another 2 years.

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