EloraTZP for weight loss in adults with overweight/obesity and type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional study compares the weight-reduction effects and safety of the eloralintide-tirzepatide coformulation (EloraTZP) to tirzepatide in adults with obesity or overweight and type 2 diabetes. Participants are adults with BMI ≥27 kg/m2 who have had limited weight loss despite prior efforts, and who meet specific medical criteria. The study lasts about two years and excludes individuals with certain prior obesity procedures, specific competing medications, or type 1 diabetes. Outcomes focus on body weight changes and safety signals related to the combination therapy. Conducted at sites in Arizona and California under Eli Lilly and partnering centers.

Why it matters

Who can join: the full rules

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

Where it's running

• Los Angeles Institute for Metabolic Research
  Los Angeles, California, United States Recruiting
• Tucson Clinical Research Institute
  Tucson, Arizona, United States Not yet recruiting
• Pacific Clinical Studies Inc.
  Los Alamitos, California, United States Not yet recruiting
• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Not yet recruiting
• American Research Centers of Florida
  Pembroke Pines, Florida, United States Not yet recruiting
• Encore Medical Research - Weston
  Weston, Florida, United States Not yet recruiting

+25 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 317-615-4559

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.