NCT06037252Active, not recruitingPhase 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 enrollmentStarted: September 21, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 414
- Locations
- 40
- Primary Endpoint
- Percent Change From Baseline in Body Weight
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- 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
- •Have a history of chronic or acute pancreatitis.
Arms & Interventions
Tirzepatide High Dose 1
Experimental
Participants will receive tirzepatide subcutaneously (SC).
Intervention: Tirzepatide (Drug)
Tirzepatide High Dose 2
Experimental
Participants will receive tirzepatide SC.
Intervention: Tirzepatide (Drug)
Tirzepatide
Active Comparator
Participants will receive tirzepatide SC.
Intervention: Tirzepatide (Drug)
Placebo
Placebo Comparator
Participants will receive placebo.
Intervention: Placebo (Drug)
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)
Investigators
Study Sites (40)
Loading locations...
Similar Trials
Completed
Phase 2
A Study to Test the Safety and Efficacy of MK0249 in Patients With ADHD (0249-018)(COMPLETED)Attention-Deficit/Hyperactivity Disorder (ADHD)NCT00475735Merck Sharp & Dohme LLC72
Completed
Phase 2
Proof of Concept and Dose-ranging Study of INDV-2000 in Individuals With Moderate to Severe Opioid Use DisorderOpioid Use DisorderNCT06384157Indivior Inc.300
Terminated
Phase 2
Randomized, Controlled Trial of Extended-Release Niacin (Niaspan®) to Augment Subacute Ischemic Stroke RecoveryIschemic StrokeNCT00796887Henry Ford Health System27
Completed
Phase 2
A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B VaccineHepatitis B, ChronicNCT04289987CHA Vaccine Institute Co., Ltd.134
Completed
Phase 2
MK0557 for the Treatment of Cognitive Impairment in Patients With Schizophrenia (0557-027)SchizophreniaParanoid SchizophreniaNCT00482430Merck Sharp & Dohme LLC50