A Study of Eloralintide (LY3841136) in Participants With Obesity, or Overweight Without Type 2 Diabetes (ENLIGHTEN-1)

Lilly

Status and phase: Not yet enrolling; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Placebo; Drug: Eloralintide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07321886

2025-523657-34-00 (Other Identifier)

J3R-MC-YDAG (Other Identifier)

27742

Details and patient eligibility

About

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.

Enrollment: 1,980 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have Body Mass Index (BMI) at screening of the following:

  • 30 kilogram per square meter (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 stable body weight (<5% body weight change) for 90 days prior to screening.

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

Exclusion criteria

• Have a prior or planned surgical treatment for obesity (liposuction, cryolipolysis, or abdominoplasty allowed if performed >1 year before screening)

• Have a prior or planned endoscopic procedure and/or device-based therapy for obesity (prior device-based therapy acceptable if device removal was more than 6 months prior to screening)

• Have type 1 diabetes or type 2 diabetes

• Have had within 90 days prior to screening:

  • heart attack
  • stroke
  • coronary artery revascularization
  • unstable angina, or
  • hospitalization due to congestive heart failure

• Have a history or diagnosis of New York Heart Association Functional Classification Class IV congestive heart failure

• Have taken medications or alternative remedies intended for weight loss within 90 days of screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,980 participants in 5 patient groups, including a placebo group

Eloralintide Dose 1

Experimental group

Description:

Participants will receive eloralintide subcutaneously (SC)

Treatment:

Drug: Eloralintide

Eloralintide Dose 2

Experimental group

Description:

Participants will receive eloralintide SC

Treatment:

Drug: Eloralintide

Eloralintide Dose 3

Experimental group

Description:

Participants will receive eloralintide SC

Treatment:

Drug: Eloralintide

Eloralintide Dose 4

Experimental group

Description:

Participants will receive eloralintide SC

Treatment:

Drug: Eloralintide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo SC

Treatment:

Drug: Placebo