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A Study of Investigational Tirzepatide (LY3298176) Doses in Participants With Type 2 Diabetes and Obesity

Recruiting
18 - 75 years of age
Both
Phase 2

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Overview

The main purpose of this study is to learn more about the safety and efficacy of investigational tirzepatide doses in participants with Type 2 diabetes and obesity that are already taking metformin. The study will last for about 89 weeks.

Description

The study will include a screening period of up to 5 weeks. The primary endpoint will be at Week 44 with a tirzepatide extension until week 80. A safety follow up will be performed approximately 4 weeks after end of treatment.

Eligibility

Inclusion Criteria

  • Have a Body Mass Index (BMI) ≥35 kilogram/square meter (kg/m²) at screening.
  • Have had stable body weight (±5%) during the 90 days preceding screening.
  • Have been diagnosed with Type 2 Diabetes (T2D).
  • Have been on a stable treatment of metformin only at least 90 days preceding screening and between screening and randomization with the minimum effective dose of ≥1500 milligram (mg)/day.

Exclusion Criteria:

  • Have Type 1 Diabetes (T1D), history of ketoacidosis or hyperosmolar state/coma, or any other types of diabetes except T2D.
  • Have had 1 or more episode of severe hypoglycemia and/or 1 or more episode of hypoglycemia unawareness within 6 months prior to screening.
  • Are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.
  • Have a prior or planned surgical treatment for obesity.
  • Use products intended for weight loss including prescription drugs, over the counter (OTC) drugs, and herbal preparations, within 3 months prior to screening.
  • Have renal impairment measured as estimated glomerular filtration rate (eGFR) <45 milliliter/min (mL/min)/1.73 m².
  • Have any of the following cardiovascular (CV) conditions within 2 months prior to screening.
    • acute myocardial infarction.
    • cerebrovascular accident (stroke).
    • unstable angina .
    • hospitalization due to congestive heart failure, or
    • coronary artery revascularization.
  • Have a family or personal history of medullary thyroid carcinoma or multiple

    endocrine neoplasia (MEN) syndrome Type 2.

  • Have a history of chronic or acute pancreatitis.

Study details

Type 2 Diabetes, Obesity

NCT06037252

Eli Lilly and Company

3 February 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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