A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, and Type 2 Diabetes (ENLIGHTEN-2)

Lilly

Status and phase: Enrolling; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Eloralintide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07282600

2025-523658-15-00 (EU Trial (CTIS) Number)

J3R-MC-YDAF (Other Identifier)

27741

Details and patient eligibility

About

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 overweight or obesity and type 2 diabetes. Participation in the study will last about 75 weeks.

Enrollment: 1,035 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have type 2 diabetes
• Are on stable treatment for type 2 diabetes for at least 90 days prior to screening
• Have a BMI ≥ 27 kg/m2
• Have a stable body weight (<5% body weight change) for 90 days prior to 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:

  • amylin analogs
  • glucagon-like peptide-1 (GLP-1) receptor agonists
  • glucose-dependent insulinotropic polypeptide/glucagon-like peptide-1 (GIP/GLP) receptor agonists, or
  • 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

• 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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1,035 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