Obesity, Type 2 Diabetes
Conditions
Keywords
Diabetes Mellitus, Glucose Metabolism Disorders, Metabolic Disease, Endocrine System Diseases, Overnutrition, Nutrition Disorders, Body Weight, Tirzepatide, Incretins
Brief summary
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.
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.
Interventions
DRUGTirzepatide
Administered SC
DRUGPlacebo
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent Change From Baseline in Body Weight | Baseline (Week 0), Week 44 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in HbA1c | Baseline (Week 0), Week 44 | — |
| Percent Change from Baseline in Body Weight | Baseline (Week 24), Week 80 | — |
| Absolute Change from Baseline in Body Weight | Baseline (Week 0), Week 44 | — |
| Change from Baseline in Body Mass Index (BMI) | Baseline (Week 0), Week 44 | — |
| Change from Baseline in BMI | Baseline (Week 24), Week 80 | — |
| Change from Baseline in Waist Circumference | Baseline (Week 0), Week 44 | — |
| Percentage of Participants Achieving ≥15% Body Weight Reduction | Baseline (Week 0), Week 44 | — |
| Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) | 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. |
Countries
Argentina, Mexico, Turkey (Türkiye), United States
Contacts
STUDY_DIRECTORCall 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Outcome results
None listed