A Study of Eloralintide (LY3841136) in Participants With Obesity or Overweight, Type 2 Diabetes, and Increased Cardiovascular Risk (ENLIGHTEN-10)

Lilly

Status and phase: Begins enrollment this month; Phase 3

Conditions: Overweight; Obesity; Cardiovascular Diseases; Diabetes Mellitus, Type 2

Treatments: Drug: Eloralintide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07900633

27870

J3R-MC-YDAS (Other Identifier)

2026-525919-14-00 (EU Trial (CTIS) Number)

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy and safety of eloralintide compared with a placebo in participants with obesity or overweight, type 2 diabetes, and increased cardiovascular risk.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have type 2 diabetes
• Have a HbA1c value between ≥ 6.5% and ≤ 9.5% at screening
• Are on stable treatment with an unchanged dose of at least 1 and no more than 4 antihyperglycemic therapies for at least 90 days before screening
• Have an increased risk of cardiovascular events
• Have a BMI ≥ 25.0 kg/m2 at screening
• 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

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

• Have had within 60 days prior to screening:

  • acute myocardial infarction
  • stroke
  • hospitalization for congestive heart failure, or
  • coronary, peripheral, or carotid artery revascularization procedure

• Have received treatment combining sulfonylurea and insulin within 90 days prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,000 participants in 2 patient groups, including a placebo group

Eloralintide

Experimental group

Description:

Participants will receive eloralintide subcutaneously (SC)

Treatment:

Drug: Eloralintide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo SC

Treatment:

Drug: Placebo