A Study of EloraTZP in Adult Participants With Obesity or Overweight and Type 2 Diabetes (AMPLIFY-2)

Lilly

Status and phase: Begins enrollment this month; Phase 3

Conditions: Overweight; Obesity; Diabetes Mellitus, Type 2

Treatments: Drug: Tirzepatide; Drug: eloralintide and tirzepatide

Study type: Interventional

Funder types: Industry

Identifiers

NCT07881458

2026-527230-31-00 (EU Trial (CTIS) Number)

J7C-MC-YQAB (Other Identifier)

27837

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy and safety of eloralintide and tirzepatide coformulation (EloraTZP) compared to tirzepatide for body weight reduction in participants with obesity or overweight and type 2 diabetes.

Participation in the study will last about 2 years.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have type 2 diabetes
• Have a stable self-reported body weight (<5% body weight change) for 90 days prior to screening
• Have a BMI of ≥27 kg/m2 at screening
• Have a history of at least 1 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 and/or type 2 diabetes (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 within 90 days prior to screening

  • medications with direct amylin, glucagon-like peptide-1 (GLP-1) or glucagon-dependent insulinotropic polypeptide (GIP) receptor activity, including compounded therapies
  • dipeptidyl peptidase 4 (DPP-4) inhibitors, and
  • 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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1,000 participants in 2 patient groups

EloraTZP

Experimental group

Description:

Participants will receive EloraTZP subcutaneously (SC)

Treatment:

Drug: eloralintide and tirzepatide

Tirzepatide

Experimental group

Description:

Participants will receive tirzepatide SC

Treatment:

Drug: Tirzepatide