Not yet recruitingPhase 3

A Study of EloraTZP in Adult Participants With Obesity or Overweight and Type 2 Diabetes

A Phase 3 Study to Investigate the Efficacy and Safety of LY900043 in Adult Participants With Obesity or Overweight and Type 2 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares EloraTZP, a mix of eloralintide and tirzepatide, with tirzepatide alone to see how safely and well it helps people lose weight. It is for adults with obesity or overweight who have type 2 diabetes. Taking part lasts about 2 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have type 2 diabetes.
  • Report that your weight changed by less than 5% in the 90 days before screening.
  • Have a BMI of 27 or higher at screening. BMI is a measure based on height and weight.
  • Report trying at least one diet to lose weight that did not work.

Who can't join

  • Have had or plan to have surgery for obesity. Liposuction, fat freezing, or a tummy tuck is allowed if done more than 1 year before screening.
  • Have had or plan to have a procedure using a scope or a medical device to treat obesity or type 2 diabetes. Past device treatment is allowed if the device was removed more than 6 months before screening.
  • Have type 1 diabetes.
  • Used insulin, DPP-4 inhibitors, or medicines that act on amylin, GLP-1, or GIP within 90 days before screening. These include certain diabetes medicines and specially mixed versions.
  • Within 90 days before screening, had a heart attack, stroke, a procedure to restore blood flow to the heart, unstable angina (heart-related chest pain), or a hospital stay for heart failure.
  • Have or have had Class IV heart failure, the most severe class of a condition in which the heart does not pump well enough.
  • Used medicines or alternative remedies meant for weight loss within 90 days of screening.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (25)

AZ

  • Tucson Clinical Research Institute · Tucson, AZ 85712Girish Karamchandani · Principal investigatorMore trials in Tucson

CA

CO

FL

GA

  • Care Access - Dalton - Clinical Trials Center by Walmart & Care Access · Dalton, GA 30720 · Study contact · 877-791-0656Chukwukanene Ofiaeli · Principal investigatorMore trials in Dalton

HI

IN

LA

MO

NJ

NY

TX

VA

  • Washington Center for Weight Management and Research · Arlington, VA 22206 · Study contact · 7038070037Domenica Rubino · Principal investigatorMore trials in Arlington

WA