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

Lilly

Status and phase: Enrolling; Phase 2

Conditions: Obesity; Type 2 Diabetes

Treatments: Drug: Tirzepatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06037252

2023-504561-24-00 (Other Identifier)

18739

I8F-MC-GPIT (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 350 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 4 patient groups, including a placebo group

Tirzepatide High Dose 1

Experimental group

Description:

Participants will receive tirzepatide subcutaneously (SC).

Treatment:

Drug: Tirzepatide

Tirzepatide High Dose 2

Experimental group

Description:

Participants will receive tirzepatide SC.

Treatment:

Drug: Tirzepatide

Tirzepatide

Active Comparator group

Description:

Participants will receive tirzepatide SC.

Treatment:

Drug: Tirzepatide

Placebo

Placebo Comparator group

Description:

Participants will receive placebo.

Treatment:

Drug: Placebo