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

Purpose

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.

Conditions

Type 2 Diabetes
Obesity

Eligibility

Eligible Ages: Between 18 Years and 75 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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 Design

Phase: Phase 2
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Masking: Double (Participant, Investigator)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Tirzepatide High Dose 1	Participants will receive tirzepatide subcutaneously (SC).	Drug: Tirzepatide Administered SC Other names: LY3298176
Experimental Tirzepatide High Dose 2	Participants will receive tirzepatide SC.	Drug: Tirzepatide Administered SC Other names: LY3298176
Active Comparator Tirzepatide	Participants will receive tirzepatide SC.	Drug: Tirzepatide Administered SC Other names: LY3298176
Placebo Comparator Placebo	Participants will receive placebo.	Drug: Placebo Administered SC

Recruiting Locations

More Details

NCT ID: NCT06037252
Status: Active, not recruiting
Sponsor: Eli Lilly and Company

Detailed 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.