The trial is taking place at:
C

Chase Medical Research, LLC | Waterbury, MA

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

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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

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

Trial contacts and locations

59

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Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from clinicaltrials.gov

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