A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight
- Registration Number
- NCT04184622
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This is a study of tirzepatide in participants with overweight and obesity. The main purpose is to learn more about how tirzepatide affects body weight. The study has two phases: A main phase and an extension phase. The main phase of the study will last 72 weeks. Participants with prediabetes will continue in the extension for another 2 years.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2539
- Body mass Index (BMI) ≥30 kilograms per square meter (kg/m²), or ≥27 kg/m² and previous diagnosis with at least one of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea, cardiovascular disease
- History of at least one unsuccessful dietary effort to lose body weight
- Diabetes mellitus
- Change in body weight greater than 5 kg within 3 months prior to starting study
- Obesity induced by other endocrinologic disorders or monogenetic or syndromic forms of obesity
- History of pancreatitis
- Family or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2)
- History of significant active or unstable major depressive disorder (MDD) or other severe psychiatric disorder within the last 2 years
- Any lifetime history of a suicide attempt
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo administered SC once a week. 10 mg Tirzepatide Tirzepatide 10 mg tirzepatide administered SC once a week. 15 mg Tirzepatide Tirzepatide 15 mg tirzepatide administered SC once a week. 5 mg Tirzepatide Tirzepatide 5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Body Weight Baseline, Week 72 Least Squares (LS) Mean was calculated using mixed-model repeated measures (MMRM) with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Percentage of Participants Who Achieve ≥5% Body Weight Reduction Week 72 Percentage of participants who achieve ≥5% body weight reduction.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Achieve ≥20% Body Weight Reduction Week 72 Percentage of participants who achieve ≥20% body weight reduction.
Percent Change From Baseline in Fasting Insulin (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 Fasting Insulin is a test used to measure the amount of insulin in the body. Results are reported as model-based estimates and SE from MMRM analysis using log transformation.
Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, Week 72 HbA1c is the glycosylated fraction of hemoglobin A. HbA1c is measured primarily to identify average plasma glucose concentration over prolonged periods of time. LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Percent Change From Baseline in Low-Density Lipoprotein (LDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Percent Change From Baseline in Free Fatty Acids (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Change From Baseline in Body Weight (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 20 LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Percentage of Participants Who Achieve ≥5% Body Weight Reduction Week 176 Percentage of Participants who Achieve ≥5% Body Weight Reduction.
Change From Baseline in Fasting Glucose Baseline, Week 72 LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Percent Change From Baseline in Triglycerides (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 Percent change from baseline in triglycerides are reported as model-based estimate and Standard Error (SE) from MMRM analysis using log transformation.
Percentage of Participants Who Achieve ≥10% Body Weight Reduction Week 72 Percentage of Participants who Achieve ≥10% Body Weight Reduction
Percentage of Participants Who Achieve ≥15% Body Weight Reduction Week 72 Percentage of participants who achieve ≥15% body weight reduction.
Change From Baseline in Waist Circumference Baseline, Week 72 LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Change From Baseline in Body Mass Index (BMI) Baseline, Week 72 LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Percent Change From Baseline in Body Weight Baseline, Week 176 Percent Change from Baseline in Body Weight.
Time to Onset of Type 2 Diabetes Baseline through Week 176 Time to Onset of Type 2 Diabetes
Percent Change From Baseline in Total Cholesterol (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Percent Change From Baseline in High-Density Lipoprotein (HDL) Cholesterol at Week 72 (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 Results are reported as model-based estimate and SE from MMRM analysis using log transformation.
Change From Baseline in Systolic Blood Pressure (SBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Change From Baseline in Diastolic Blood Pressure (DBP) (Pooled Doses of Tirzepatide 5 mg, 10 mg and 15 mg) Baseline, Week 72 LS Mean was calculated using MMRM with baseline, analysis country, sex, prediabetes status at randomization, treatment, time, treatment\*time (Type III sum of squares) in the model.
Change From Baseline in Short Form Survey-36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 72 (Pooled Doses of Tirzepatide 10 mg and 15 mg) Baseline, Week 72 The SF-36v2 acute, 1-week recall version is a 36-item, generic, patient-administered measure designed to assess the following 8 domains: Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health. The Physical-Functioning domain assesses limitations due to health "now" while the remaining domains assess functioning "in the past week." Each domain is scored individually and information from these 8 domains are further aggregated into 2 health-component summary scores: Physical-Component Summary and Mental-Component Summary. Items are answered on Likert scales of varying lengths (3-, 5-, or 6- point scales).The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health.
Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72 Baseline, Week 72 The IWQOL-Lite-CT is a 20-item, obesity-specific PRO instrument developed for use in obesity clinical trials. It assesses 2 primary domains of obesity-related health-related quality of life (HRQoL): physical (7 items), and psychosocial (13 items). A 5-item subset of the physical domain, the physical-function composite is also supported. Items in the physical-function composite describe physical impacts related to general and specific physical activities. All items in the physical domain are rated on either a 5-point frequency ("never" to "always") scale or a 5-point truth ("not at all true" to "completely true") scale. Total score of IWQOL-Lite-CT composite ranges from 0 to 100, with higher scores reflecting better quality of life.
Pharmacokinetics (PK): Steady State Area Under the Concentration Time Curve (AUC) of Tirzepatide Week 8, 16, and 36, at 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose PK: Steady State AUC of Tirzepatide. each participant will be assigned via the Interactive Web Response System (IWRS) to one of the sampling PK time windows of 1 to 24 hours, 24 to 96 hours, or 120 to 168 hours postdose.
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Trial Locations
- Locations (117)
Cahaba Research
🇺🇸Pelham, Alabama, United States
Perseverance Research Center
🇺🇸Scottsdale, Arizona, United States
John Muir Physician Network Clinical Research Center
🇺🇸Concord, California, United States
Valley Research
🇺🇸Fresno, California, United States
National Research Institute - Wilshire
🇺🇸Los Angeles, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
University Clinical Investigators, Inc.
🇺🇸Tustin, California, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Scroll for more (107 remaining)Cahaba Research🇺🇸Pelham, Alabama, United States