A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program
- Registration Number
- NCT04657016
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 579
- Have a body mass index (BMI) ≥30 kg/m2 or ≥27 kg/m2 and previously diagnosed with at least 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or 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 Participants received matching placebo SC once weekly (QW). Tirzepatide Tirzepatide Participants received weekly doses of tirzepatide subcutaneously (SC) for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Body Weight Baseline, 72 Weeks Percent change from baseline in body weight. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percentage of Participants With Greater Than or Equal to (≥) 5% Body Weight Reduction Week 72 Percentage of participants with ≥5% body weight reduction was analysed by Logistic regression model using imputed data with baseline body weight, Analysis Country, Sex, Treatment as factors.
- Secondary Outcome Measures
Name Time Method Percentage of Participants Who Maintain ≥80% of the Body Weight Lost During Intensive Lifestyle Program 72 Weeks Percentage of participants who maintain ≥80% of the body weight lost during intensive lifestyle program was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.
Change From Baseline in Waist Circumference Baseline, 72 Weeks Change from baseline in waist circumference. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percentage of Participants Who Achieve ≥10%Body Weight Reduction 72 Weeks Percentage of participants who achieve ≥10% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.
Change From Baseline in Body Mass Index (BMI) Baseline, 72 Weeks Change from baseline in BMI. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares).
Change From Baseline in Systolic Blood Pressure (SBP) Baseline, 72 Weeks Change from baseline in SBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percent Change From Baseline in High Density Lipoprotein (HDL) Cholesterol Baseline, 72 Weeks Percent change from baseline in HDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percent Change From Baseline in Low Density Lipoprotein (LDL) Cholesterol Baseline, 72 Weeks Percent change from baseline in LDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percent Change From Baseline in Very Low-Density Lipoprotein (VLDL) Cholesterol Baseline, 72 Weeks Percent change from baseline in VLDL cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
Change From Baseline in Fasting Glucose Baseline, 72 Weeks Change from baseline in fasting glucose. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
Change From Baseline in Hemoglobin A1c (HbA1c) Baseline, 72 Weeks 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 determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percent Change From Baseline in Fasting Insulin Baseline, 72 Weeks Percent change from baseline in fasting insulin. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
Change From Baseline in Short Form 36 Version 2 Health Survey Version 2 (SF 36v2) Acute Form Physical Functioning Domain Score Baseline, 72 Weeks The SF-36v2 acute form assesses health-related quality of life (HRQoL) on 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" and consists of 10-items, each rated on a 3-point Likert scale. Scoring of the domain is norm-based and presented in the form of T-scores, with a mean of 50 and standard deviation of 10; higher scores indicate better levels of function. Range cannot be specified in norm-based scores.
LS mean was determined using analysis of covariance (ANCOVA) model using Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.Percentage of Participants Who Achieve ≥15% Body Weight Reduction 72 Weeks Percentage of participants who achieve ≥15% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.
Percentage of Participants Who Achieve ≥20% Body Weight Reduction 72 Weeks Percentage of participants who achieve ≥20% body weight reduction was analysed by logistic regression model using imputed data with baseline body weight, analysis country, sex, treatment as factors.
Change From Baseline in Body Weight Baseline, 72 Weeks Change from baseline in body weight. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Treatment + Time + Treatment\*Time (Type III sum of squares).
Change From Baseline in Impact of Weight on Quality of Life Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score Baseline, 72 Weeks The IWQOL Lite-CT consists of 20 items, assessing 2 primary domains of obesity related 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 health-related quality of life.
LS mean was determined using ANCOVA model with Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment (Type III sum of squares) as variables.Change From Baseline in Diastolic Blood Pressure (DBP) Baseline, 72 Weeks Change from baseline in DBP. LS mean was determined by MMRM model for post-baseline measures: Variable = Baseline + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percent Change From Baseline in Total Cholesterol Baseline, 72 Weeks Percent change from baseline in total cholesterol. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percent Change From Baseline in Triglycerides Baseline, 72 Weeks Percent change from baseline in triglycerides. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
Percent Change From Baseline in Free Fatty Acids Baseline, 72 Weeks Percent change from baseline in free fatty acids. LS mean was determined by MMRM model for post-baseline measures: log(Actual Measurement/Baseline) = log(Baseline) + Analysis Country + Sex + Lead-In Weight Loss % + Treatment + Time + Treatment\*Time (Type III sum of squares).
Trial Locations
- Locations (62)
National Research Institute - Huntington Park
🇺🇸Huntington Park, California, United States
National Research Institute - Wilshire
🇺🇸Los Angeles, California, United States
Catalina Research Institute, LLC
🇺🇸Montclair, California, United States
National Research Institute (NRI) - Santa Ana
🇺🇸Santa Ana, California, United States
Encompass Clinical Research
🇺🇸Spring Valley, California, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
Clinical Research of South Florida
🇺🇸Coral Gables, Florida, United States
New Horizon Research Center
🇺🇸Miami, Florida, United States
Precision Clinical Research
🇺🇸Sunrise, Florida, United States
Scroll for more (52 remaining)National Research Institute - Huntington Park🇺🇸Huntington Park, California, United States