A Study of Eloralintide (LY3841136) in Participants With Persistent Obesity Who Are Treated With a Weekly Incretin (ENLIGHTEN-6)

Lilly

Status and phase: Begins enrollment this month; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Placebo; Drug: Eloralintide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07392190

2025-523659-73-00 (EU Trial (CTIS) Number)

J3R-MC-YDAL (Other Identifier)

27743

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with placebo in participants with persistent obesity or overweight, with or without type 2 diabetes, and on stable incretin background therapy.

Participation in the study will last about 80 weeks.

Enrollment: 900 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are on stable incretin therapy at screening

• With persistent obesity or overweight defined as:

  • ≥30 kg/m2 OR

  • ≥27 kg/m2 with at least one existing obesity related complication at screening:

    • hypertension
    • dyslipidemia
    • obstructive sleep apnea
    • cardiovascular disease (for example, ischemic cardiovascular disease, New York Heart Association Functional Class I-III heart failure), or
    • type 2 diabetes

• Have a stable body weight (<5% body weight change) at screening

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

• Have taken any of the following antihyperglycemic medications within 90 days before screening:

  • dipeptidyl peptidase-4 (DPP-4) inhibitors
  • amylin analogs
  • insulin

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

900 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