Type 2 Diabetes Mellitus (T2DM)
Conditions
Interventions
Product Name: Tirzepatide
Product Code: [LY3298176]
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Tirzepatide
Current Sponsor code: LY3298176
Concentration unit: m
Sponsors
ELI LILLY & COMPANY, LILLY CORPORATE CENTER
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant must be 10 to 6.5% to =11% at screening visit (determined by central laboratory). 4. Body weight =50 kg and BMI of >85th percentile of the general age and gender-matched population for that country or region. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Have T1DM. 2. AFTER the diagnosis of T2DM, have a history of diabetic ketoacidosis or hyperosmolar syndrome. 3. Have diabetes-associated autoantibodies (GAD65 and/or IA2), historically or at Visit 1. 4. Have had >=1 episode of severe hypoglycemia and/or >=1 episode of hypoglycemic unawareness within the last 6 months. 5. Have history of: proliferative diabetic retinopathy, or diabetic macular edema, or non-proliferative diabetic retinopathy that requires acute treatment. 6. Have family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN2). 7. Had chronic or acute pancreatitis any time prior to study entry (Visit 1). 8. Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than Nonalcoholic fatty liver disease (NAFLD), or ALT or AST level >5.0 times the upper limit of the age-adjusted reference range, or Total bilirubin = 1.5 times the upper limit of the age-adjusted reference range (except in the case of Gilbert’s syndrome) as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this study only if their ALT and AST levels are =5.0 times the ULN for the reference range and Total bilirubin level is < 1.5 times the ULN at screening. 9. Have an estimated glomerular filtration rate <45 mL/min/1.73 m2, calculated by Chronic Kidney Disease-Epidemiology as determined by central laboratory at Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that pooled 5 mg and 10 mg tirzepatide once weekly (QW) is superior to placebo at 30 weeks.;Secondary Objective: To demonstrate that 5 mg and 10 mg tirzepatide QW, analyzed as pooled and/or separate treatment arms, is superior to placebo at 30 weeks. To assess the effect of 5 mg and 10 mg tirzepatide QW, analyzed as pooled and separate treatment arms, at 52 weeks. To assess safety of 5 mg and 10 mg tirzepatide QW, analyzed as pooled and separate treatment arms, at 30 weeks and at the end of the safety follow-up period. To compare 5 mg, and 10 mg tirzepatide QW, analyzed as pooled and separate treatment arms, to placebo at 30 weeks. To assess the safety of 5 mg and 10 mg tirzepatide QW, analyzed as separate and pooled arms, at 52 weeks for diabetic retinopathy. Characterize the pharmacokinetics and pharmacodynamic relationships of tirzepatide. To assess the effect of 5 mg, and 10 mg tirzepatide QW, analyzed as pooled and separate treatment arms, on patient reported outcomes at 30 and 52 weeks.;Primary end point(s): To measure a change in hemoglobin A1c (HbA1c) from baseline.;Timepoint(s) of evaluation of this end point: 30 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Incidence of HbA1c <=6.5%. Change in body mass index (BMI) standard deviation score (age- and sex-matched) from baseline. Change in fasting serum glucose (FSG) from baseline. Change in HbA1c from baseline. Incidence of HbA1c <7.0%. Incidence of HbA1c <5.7%. Change in daily average 6-point self-monitored blood glucose profiles from baseline. Change from baseline for serum lipid levels. Incidence of new or worsening of dyslipidemia. Treatment-emergent adverse events (TEAEs). Discontinuation of study intervention due to adverse events (AEs). Adjudicated pancreatic AEs. Serum calcitonin. Incidence of allergic, hypersensitivity reactions, and injection site reactions. Incidence of treatment-emergent anti-drug antibodies to tirzepatide. Change in systolic and diastolic blood pressure and heart rate from baseline. Incidence of new or worsening of hypertension. Incidence of new or worsening of albuminuria. Occurrence of hypoglycemic events. Incidence of initiation of rescue therapy for severe persistent hyperglycemia. Incidence of new or worsening of diabetic neuropathy. Change from baseline for physical and developmental measures (Height and weight, Height SDS and weight SDS, Waist circumference, and Tanner Staging). Incidence of new or worsening of diabetic retinopathy or diabetic maculopathy in either eye. Relationship between tirzepatide exposure and key safety and efficacy measures. Change from baseline for PedsQL Generic Core Scales and PedsQL (3.2) Diabetic Module from baseline.;Timepoint(s) of evaluation of this end point: At 30 weeks, 52 weeks and when an AE is reported. | — |
Countries
Australia, Brazil, France, India, Israel, Italy, Mexico, United Kingdom, United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly
Outcome results
None listed