Clinical Trials/NCT06037252

NCT06037252

Active, not recruiting

Phase 2

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

Eli Lilly and Company40 sites in 4 countries414 target enrollmentSeptember 21, 2023

ConditionsType 2 Diabetes Obesity

InterventionsTirzepatide Placebo

DrugsTirzepatide Placebo

Overview

Phase: Phase 2
Intervention: Tirzepatide
Conditions: Type 2 Diabetes
Sponsor: Eli Lilly and Company
Enrollment: 414
Locations: 40
Primary Endpoint: Percent Change From Baseline in Body Weight
Status: Active, not recruiting
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 21, 2023

End Date

October 1, 2026

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Eli Lilly and Company

Responsible Party

Sponsor

Eligibility 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 .

Arms & Interventions

Tirzepatide High Dose 1

Participants will receive tirzepatide subcutaneously (SC).

Intervention: Tirzepatide

Tirzepatide High Dose 2

Participants will receive tirzepatide SC.

Intervention: Tirzepatide

Tirzepatide

Participants will receive tirzepatide SC.

Intervention: Tirzepatide

Placebo

Participants will receive placebo.

Intervention: Placebo

Outcomes

Primary Outcomes

Percent Change From Baseline in Body Weight

Time Frame: Baseline (Week 0), Week 44

Secondary Outcomes

Absolute Change from Baseline in Body Weight(Baseline (Week 24), Week 80)
Change from Baseline in Body Mass Index (BMI)(Baseline (Week 0), Week 44)
Percentage of Participants Achieving ≥15% Body Weight Reduction(Baseline (Week 0), Week 80)
Change from Baseline in HbA1c(Baseline (Week 24), Week 80)
Percent Change from Baseline in Body Weight(Baseline (Week 24), Week 80)
Change from Baseline in BMI(Baseline (Week 24), Week 80)
Change from Baseline in Waist Circumference(Baseline (Week 24), Week 80)
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC)(Baseline through Week 44)
Percentage of Participants Achieving ≥15% Body Weight Reduction(Baseline (Week 0), Week 44)
Change from Baseline in HbA1c(Baseline (Week 0), Week 44)
Absolute Change from Baseline in Body Weight(Baseline (Week 0), Week 44)
Change from Baseline in Waist Circumference(Baseline (Week 0), Week 44)