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Active, Not Recruiting

NCT Number: NCT06037252

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CEDIC, CABA, Buenos Aires, Argentina

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tirzepatide

Drug

Administered SC

Other names: LY3298176

Placebo

Drug

Administered SC

Primary outcomes

  1. Percent Change From Baseline in Body Weight

    Time frame: Baseline (Week 0), Week 44

Secondary outcomes

  1. Change from Baseline in HbA1c

    Time frame: Baseline (Week 0), Week 44

  2. Change from Baseline in HbA1c

    Time frame: Baseline (Week 24), Week 80

  3. Percent Change from Baseline in Body Weight

    Time frame: Baseline (Week 24), Week 80

  4. Absolute Change from Baseline in Body Weight

    Time frame: Baseline (Week 0), Week 44

  5. Absolute Change from Baseline in Body Weight

    Time frame: Baseline (Week 24), Week 80

  6. Change from Baseline in Body Mass Index (BMI)

    Time frame: Baseline (Week 0), Week 44

  7. Change from Baseline in BMI

    Time frame: Baseline (Week 24), Week 80

  8. Change from Baseline in Waist Circumference

    Time frame: Baseline (Week 0), Week 44

  9. Change from Baseline in Waist Circumference

    Time frame: Baseline (Week 24), Week 80

  10. Percentage of Participants Achieving ≥15% Body Weight Reduction

    Time frame: Baseline (Week 0), Week 44

  11. Percentage of Participants Achieving ≥15% Body Weight Reduction

    Time frame: Baseline (Week 0), Week 80

  12. Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)

    Time frame: Baseline through Week 44

    Steady State Area Under the Concentration Time Curve (AUC) presented as a single average measure of AUC across the time frame.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Investigational Tirzepatide Doses in Participants With Type 2 Diabetes and Obesity

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2023
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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