Recruiting
Phase 3

Eloralintide & Tirzepatide

Sponsor:

Eli Lilly and Company

Code:

NCT07881458

Conditions

Obesity

Overweight

Diabetes Mellitus, Type 2

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

eloralintide and tirzepatide

Tirzepatide

Study Details

Brief summary:

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.

Conditions

Obesity

Overweight

Diabetes Mellitus, Type 2

Study ID

NCT07881458

Start date

Oct 16, 2026

Status verified date

Nov, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Oct, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: EloraTZP

Participants will receive EloraTZP subcutaneously (SC)

experimental: Tirzepatide

Participants will receive tirzepatide SC

Interventions

eloralintide and tirzepatide

Administered SC

Tirzepatide

Administered SC

Primary outcome measure

  • Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 100 ]

Central Contacts and Locations

Central contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

317-615-4559LillyTrials@Lilly.com

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

Locations

Los Angeles Institute for Metabolic Research

Recruiting

Los Angeles, California, United States, 90015

Contacts

213-373-8380

Principal Investigator:

Juan Frias

More Information

Sponsor

Eli Lilly and Company

Last update posted

Nov 4, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-05. This information was provided to ClinicalTrials.gov by Eli Lilly and Company on 2026-11-04. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.